Abstract

In this issue are two reports of randomized controlled trials of two topical skin care products used with the goal of mitigating radiation dermatitis in breast cancer patients. One trial, by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) compared mometasone furoate cream to an aqueous type cream placebo. The other trial, by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar), compared a product that combined many natural ingredients versus an aqueous type cream placebo. Acute radiation dermatitis is one of the most common side effects of radiation therapy for breast cancer. However, recent randomized studies have shown little progress in developing topical agents that are better than aqueous placebo in preventing or treating dermatitis (3Pinnix C. Perkins G.H. Strom E.A. et al.Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.Int J Radiat Oncol Biol Phys. 2012; 83: 1089-1094Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar, 4Sharp L. Finnilä K. Johansson H. et al.No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions—results from a randomised blinded trial.Eur J Oncol Nurs. 2013; 17: 429-435Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 5Graham P.H. Plant N. Graham J.L. et al.A Paired, Double-Blind, Randomized Comparison of a Moisturizing Durable Barrier Cream to 10% Glycerine Cream in the Prophylactic Management of postmastectomy Irradiation Skin Care: Trans Tasman Radiation Oncology Group (TROG) 04.01.Int J Radiat Oncol Biol Phys. 2013; 86: 45-50Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar).The study by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) used mometasone furoate cream. The mometasone furoate reduced average dermatitis scores by 0.123 compared to placebo; Figure 2 in their report shows the mean scores reduced from approximately 1.45 to 1.3. According to their dermatitis scale, that would mean the erythema observed was faint or dull but perhaps a little less so with the test agent. Is this clinically significant? The overall skin dermatitis was lower than expected, a projected 10% incidence of grade 3 dermatitis for placebo was too high (it is more like 1% in modern series). However, there was an overall 10% reduction in peak dermatitis scores of 2.5, suggesting that up to 1 in 10 women might have avoided or at least had reduced moist desquamation. In association with this, for approximately 2 weeks during weeks 4 to 6, the study questionnaires confirmed better quality of life scores with mometasone furoate. The study by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar) compared a natural oil-based emulsion containing allantoin to an aqueous placebo in a randomized trial. Only half of the patients in the study were treated for breast cancer. There was lower grade 2 or more skin toxicity with breast cancer than lung cancer. There were overall no differences in dermatitis scores at the end of treatment and after radiation, for the test agent. There were no major differences in pain, itching, or skin-related quality of life either.So where's the beef, biology? There is somewhat of a biological hypothesis to mometasone furoate, in as much as glucocorticosteroids may reduce mediators of inflammation in the skin that are responsible for radiation dermatitis. However, this is not necessarily novel: topical steroids have been used in dermatology to reduce inflammation for over 50 years. The main reason for conducting this trial seemed to be to confirm a previous study showing a therapeutic effect of this formulation. In contrast, the test agent in the study by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar) was a complex mixture of allantoin, oils, plant extracts, vitamins, and many other naturally based ingredients. There is no specific scientific mechanism of action stated for this product. The main reason for this trial seemed to be a test of the anecdotal evidence behind the cream, the use of the product was increasing by patient testimonial and word of mouth alone. The company deserves credit for supporting a scientific trial in the first place. Internet products can sell products, and patients can be convinced by anecdotes to buy products, without “scientific” studies, whereas a negative clinical trial has significant downside risk (see the study testing Biafine by Fisher et al [6Fisher J. Scott C. Stevens R. et al.Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13.Int J Radiat Oncol Biol Phys. 2000; 48: 1307-1310Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar]). Unfortunately, a paid endorsement (Dr Oz?) could be a better investment than a phase 3 trial for a company looking to increase sales.If extraordinary claims require extraordinary proof, what kind of proof is needed for rather ordinary claims, such as a slight reduction in shades of redness or skin pain during treatment, shall we say ordinary proof? The days of a prospective national randomized phase 3 trial in the United States cooperative groups to investigate a skin care product are long gone (6Fisher J. Scott C. Stevens R. et al.Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13.Int J Radiat Oncol Biol Phys. 2000; 48: 1307-1310Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar). The number of groups and funding for the number of studies has been diminished. Managing a side effect that for most women is relatively mild is not going to be a priority for the cooperative groups or National Institutes of Health or Department of Defense, and there is insufficient funding through any mechanism to create trials to prove or disprove every natural product that spreads by word of mouth or through the internet. In the future, new agents purported to mitigate radiation dermatitis will need to have (1) a novel biological rationale and (2) an extraordinary claim of effectiveness in order to be considered worthwhile for the resources needed for a funded phase 3 trial.Future studies should be well designed and appropriately powered. For example, a 2-sided hypothesis test needs to be used because previous trials have shown in some cases worse outcomes with the test product compared to the placebo (3Pinnix C. Perkins G.H. Strom E.A. et al.Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.Int J Radiat Oncol Biol Phys. 2012; 83: 1089-1094Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar). Most single-institution studies are too small and cannot stratify subjects well enough to control for differences in patient characteristics that could affect dermatitis such as breast size. I think the best practice is to use the patient as her own control and mitigate the influence of other patient- and treatment-related factors by using the test agent and placebo on different halves of the irradiated surface (3Pinnix C. Perkins G.H. Strom E.A. et al.Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.Int J Radiat Oncol Biol Phys. 2012; 83: 1089-1094Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar, 5Graham P.H. Plant N. Graham J.L. et al.A Paired, Double-Blind, Randomized Comparison of a Moisturizing Durable Barrier Cream to 10% Glycerine Cream in the Prophylactic Management of postmastectomy Irradiation Skin Care: Trans Tasman Radiation Oncology Group (TROG) 04.01.Int J Radiat Oncol Biol Phys. 2013; 86: 45-50Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar). Another limitation of most studies of dermatitis is the inadequacy of the scoring system. The definitions used in common terminology criteria for dermatitis include adjectives such as mild or moderate or mostly, which are subjective and may allow substantial interobserver variation. A strength of the study by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) was the use of an objective measure of erythema, a reflectance spectrophotometer, but this is not widely used clinically. Furthermore, pain is not an element of the scoring system, so that each grade encompasses substantial variability in the severity of symptoms experienced by patients. For example, a small, 1-cm nonpainful area of moist desquamation in the inframammary fold is scored as grade 2, as would an area of painless moderate erythema without desquamation, as well as a 10-cm painful area of moist desquamation requiring narcotics and a treatment break.After reading both studies, I remain convinced that technology and physics have trumped biology and skin care in the past 10 years for reducing dermatitis and improving quality of life during breast radiation. Radiation dermatitis is most directly related to increased dose inhomogeneity that comes with larger size, skin folds, or both. The greatest source of reduction in dermatitis in the past decade has been improvements in radiation homogeneity and positioning techniques (7Pignol J. Olivotto I. Rakovitch E. et al.A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis.J Clin Oncol. 2008; 26: 2085-2092Crossref PubMed Scopus (568) Google Scholar, 8Donovan E. Bleakley N. Denholm E. et al.Randomised trial of standard 2D radiotherapy (RT) versus intensity modulated radiotherapy (IMRT) in patients prescribed breast radiotherapy.Radiother Oncol. 2007; 82: 254-264Abstract Full Text Full Text PDF PubMed Scopus (366) Google Scholar, 9Mulliez T. Veldeman L. van Greveling A. et al.Hypofractionated whole breast irradiation for patients with large breasts: A randomized trial comparing prone and supine positions.Radiother Oncol. 2013; 108: 203-208Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar). Both of these studies in this issue may not have used state-of-the-art positioning and planning techniques. The study by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) used a radiation technique somewhat better than wedged tangents, but the study by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar) provided little detail about the radiation technique. Neither study took full advantage of modern volume-based planning, with 3D conformal forward planning or inverse planned intensity modulation, with set goals for doses and volumes to the whole breast and boost targets (10Radiation Therapy Oncology Group website. RTOG 1005 protocol information: a phase III trial of accelerated whole breast irradiation with hypofractionation plus concurrent boost versus standard whole breast irradiation plus sequential boost for early-stage breast cancer. Available at: http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1005. Accessed June 20, 2014.Google Scholar). I would rather have a prone board and prescribe a cheap bottle of aqueous moisturizer for a women with a pendulous breast than treat her in the supine position with an expensive cream applied to her inframammary fold.In summary, there are numerous products used for dermatitis, but they may all be the same placebo. We should not be pushing expensive products or brands without evidence. I tell my patients to use the cheapest available aqueous type cream several times a day at first, which usually gets them through the first several weeks. Then, as a rash or pruritis develops, I recommend a petroleum-based emollient, with or without over-the-counter strength lidocaine jelly mixed in, or over-the-counter strength steroid cream. Fortunately, moist desquamation is uncommon but can be managed by a solution of aluminum acetate and water and silver sulfadiazine with nonstick dressing until resolved.Fortunately, the technology has minimized the impact of dermatitis for most women. I know there is no comparison between the observed incidence or severity of dermatitis I saw on the on-treatment-day of my residency in 1994 and the dermatitis my residents see now on our on-treatment-day in 2014. We do not need to do any debridement anymore, and I cannot recall the last time a patient needed a break between the whole-breast and boost phases of treatment. However, even if we do not yet have much to work with, skin care during radiation still requires a bit of old-fashioned country medicine and bedside manner. We need to express concern and reassurance and compassion and use what we have to palliate symptoms as best as possible, and I cannot emphasize enough the benefit of seeing patients with dermatitis in the clinic with an equally experienced and compassionate nurse. In this issue are two reports of randomized controlled trials of two topical skin care products used with the goal of mitigating radiation dermatitis in breast cancer patients. One trial, by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) compared mometasone furoate cream to an aqueous type cream placebo. The other trial, by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar), compared a product that combined many natural ingredients versus an aqueous type cream placebo. Acute radiation dermatitis is one of the most common side effects of radiation therapy for breast cancer. However, recent randomized studies have shown little progress in developing topical agents that are better than aqueous placebo in preventing or treating dermatitis (3Pinnix C. Perkins G.H. Strom E.A. et al.Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.Int J Radiat Oncol Biol Phys. 2012; 83: 1089-1094Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar, 4Sharp L. Finnilä K. Johansson H. et al.No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions—results from a randomised blinded trial.Eur J Oncol Nurs. 2013; 17: 429-435Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 5Graham P.H. Plant N. Graham J.L. et al.A Paired, Double-Blind, Randomized Comparison of a Moisturizing Durable Barrier Cream to 10% Glycerine Cream in the Prophylactic Management of postmastectomy Irradiation Skin Care: Trans Tasman Radiation Oncology Group (TROG) 04.01.Int J Radiat Oncol Biol Phys. 2013; 86: 45-50Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar). The study by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) used mometasone furoate cream. The mometasone furoate reduced average dermatitis scores by 0.123 compared to placebo; Figure 2 in their report shows the mean scores reduced from approximately 1.45 to 1.3. According to their dermatitis scale, that would mean the erythema observed was faint or dull but perhaps a little less so with the test agent. Is this clinically significant? The overall skin dermatitis was lower than expected, a projected 10% incidence of grade 3 dermatitis for placebo was too high (it is more like 1% in modern series). However, there was an overall 10% reduction in peak dermatitis scores of 2.5, suggesting that up to 1 in 10 women might have avoided or at least had reduced moist desquamation. In association with this, for approximately 2 weeks during weeks 4 to 6, the study questionnaires confirmed better quality of life scores with mometasone furoate. The study by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar) compared a natural oil-based emulsion containing allantoin to an aqueous placebo in a randomized trial. Only half of the patients in the study were treated for breast cancer. There was lower grade 2 or more skin toxicity with breast cancer than lung cancer. There were overall no differences in dermatitis scores at the end of treatment and after radiation, for the test agent. There were no major differences in pain, itching, or skin-related quality of life either. So where's the beef, biology? There is somewhat of a biological hypothesis to mometasone furoate, in as much as glucocorticosteroids may reduce mediators of inflammation in the skin that are responsible for radiation dermatitis. However, this is not necessarily novel: topical steroids have been used in dermatology to reduce inflammation for over 50 years. The main reason for conducting this trial seemed to be to confirm a previous study showing a therapeutic effect of this formulation. In contrast, the test agent in the study by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar) was a complex mixture of allantoin, oils, plant extracts, vitamins, and many other naturally based ingredients. There is no specific scientific mechanism of action stated for this product. The main reason for this trial seemed to be a test of the anecdotal evidence behind the cream, the use of the product was increasing by patient testimonial and word of mouth alone. The company deserves credit for supporting a scientific trial in the first place. Internet products can sell products, and patients can be convinced by anecdotes to buy products, without “scientific” studies, whereas a negative clinical trial has significant downside risk (see the study testing Biafine by Fisher et al [6Fisher J. Scott C. Stevens R. et al.Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13.Int J Radiat Oncol Biol Phys. 2000; 48: 1307-1310Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar]). Unfortunately, a paid endorsement (Dr Oz?) could be a better investment than a phase 3 trial for a company looking to increase sales. If extraordinary claims require extraordinary proof, what kind of proof is needed for rather ordinary claims, such as a slight reduction in shades of redness or skin pain during treatment, shall we say ordinary proof? The days of a prospective national randomized phase 3 trial in the United States cooperative groups to investigate a skin care product are long gone (6Fisher J. Scott C. Stevens R. et al.Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13.Int J Radiat Oncol Biol Phys. 2000; 48: 1307-1310Abstract Full Text Full Text PDF PubMed Scopus (240) Google Scholar). The number of groups and funding for the number of studies has been diminished. Managing a side effect that for most women is relatively mild is not going to be a priority for the cooperative groups or National Institutes of Health or Department of Defense, and there is insufficient funding through any mechanism to create trials to prove or disprove every natural product that spreads by word of mouth or through the internet. In the future, new agents purported to mitigate radiation dermatitis will need to have (1) a novel biological rationale and (2) an extraordinary claim of effectiveness in order to be considered worthwhile for the resources needed for a funded phase 3 trial. Future studies should be well designed and appropriately powered. For example, a 2-sided hypothesis test needs to be used because previous trials have shown in some cases worse outcomes with the test product compared to the placebo (3Pinnix C. Perkins G.H. Strom E.A. et al.Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.Int J Radiat Oncol Biol Phys. 2012; 83: 1089-1094Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar). Most single-institution studies are too small and cannot stratify subjects well enough to control for differences in patient characteristics that could affect dermatitis such as breast size. I think the best practice is to use the patient as her own control and mitigate the influence of other patient- and treatment-related factors by using the test agent and placebo on different halves of the irradiated surface (3Pinnix C. Perkins G.H. Strom E.A. et al.Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.Int J Radiat Oncol Biol Phys. 2012; 83: 1089-1094Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar, 5Graham P.H. Plant N. Graham J.L. et al.A Paired, Double-Blind, Randomized Comparison of a Moisturizing Durable Barrier Cream to 10% Glycerine Cream in the Prophylactic Management of postmastectomy Irradiation Skin Care: Trans Tasman Radiation Oncology Group (TROG) 04.01.Int J Radiat Oncol Biol Phys. 2013; 86: 45-50Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar). Another limitation of most studies of dermatitis is the inadequacy of the scoring system. The definitions used in common terminology criteria for dermatitis include adjectives such as mild or moderate or mostly, which are subjective and may allow substantial interobserver variation. A strength of the study by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) was the use of an objective measure of erythema, a reflectance spectrophotometer, but this is not widely used clinically. Furthermore, pain is not an element of the scoring system, so that each grade encompasses substantial variability in the severity of symptoms experienced by patients. For example, a small, 1-cm nonpainful area of moist desquamation in the inframammary fold is scored as grade 2, as would an area of painless moderate erythema without desquamation, as well as a 10-cm painful area of moist desquamation requiring narcotics and a treatment break. After reading both studies, I remain convinced that technology and physics have trumped biology and skin care in the past 10 years for reducing dermatitis and improving quality of life during breast radiation. Radiation dermatitis is most directly related to increased dose inhomogeneity that comes with larger size, skin folds, or both. The greatest source of reduction in dermatitis in the past decade has been improvements in radiation homogeneity and positioning techniques (7Pignol J. Olivotto I. Rakovitch E. et al.A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis.J Clin Oncol. 2008; 26: 2085-2092Crossref PubMed Scopus (568) Google Scholar, 8Donovan E. Bleakley N. Denholm E. et al.Randomised trial of standard 2D radiotherapy (RT) versus intensity modulated radiotherapy (IMRT) in patients prescribed breast radiotherapy.Radiother Oncol. 2007; 82: 254-264Abstract Full Text Full Text PDF PubMed Scopus (366) Google Scholar, 9Mulliez T. Veldeman L. van Greveling A. et al.Hypofractionated whole breast irradiation for patients with large breasts: A randomized trial comparing prone and supine positions.Radiother Oncol. 2013; 108: 203-208Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar). Both of these studies in this issue may not have used state-of-the-art positioning and planning techniques. The study by Hindley et al (1Hindley A.C. Zain Z. Wood L. et al.Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiotherapy: the results of a randomized trial.Int J Radiat Oncol Biol Phys. 2014; 90: 748-755Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar) used a radiation technique somewhat better than wedged tangents, but the study by Chan et al (2Chan R.J. Mann J. Tripcony L. et al.A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation induced skin reactions in patients with cancer: a phase III double-blind randomized controlled trial.Int J Radiat Oncol Biol Phys. 2014; 90: 756-764Abstract Full Text Full Text PDF Scopus (24) Google Scholar) provided little detail about the radiation technique. Neither study took full advantage of modern volume-based planning, with 3D conformal forward planning or inverse planned intensity modulation, with set goals for doses and volumes to the whole breast and boost targets (10Radiation Therapy Oncology Group website. RTOG 1005 protocol information: a phase III trial of accelerated whole breast irradiation with hypofractionation plus concurrent boost versus standard whole breast irradiation plus sequential boost for early-stage breast cancer. Available at: http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1005. Accessed June 20, 2014.Google Scholar). I would rather have a prone board and prescribe a cheap bottle of aqueous moisturizer for a women with a pendulous breast than treat her in the supine position with an expensive cream applied to her inframammary fold. In summary, there are numerous products used for dermatitis, but they may all be the same placebo. We should not be pushing expensive products or brands without evidence. I tell my patients to use the cheapest available aqueous type cream several times a day at first, which usually gets them through the first several weeks. Then, as a rash or pruritis develops, I recommend a petroleum-based emollient, with or without over-the-counter strength lidocaine jelly mixed in, or over-the-counter strength steroid cream. Fortunately, moist desquamation is uncommon but can be managed by a solution of aluminum acetate and water and silver sulfadiazine with nonstick dressing until resolved. Fortunately, the technology has minimized the impact of dermatitis for most women. I know there is no comparison between the observed incidence or severity of dermatitis I saw on the on-treatment-day of my residency in 1994 and the dermatitis my residents see now on our on-treatment-day in 2014. We do not need to do any debridement anymore, and I cannot recall the last time a patient needed a break between the whole-breast and boost phases of treatment. However, even if we do not yet have much to work with, skin care during radiation still requires a bit of old-fashioned country medicine and bedside manner. We need to express concern and reassurance and compassion and use what we have to palliate symptoms as best as possible, and I cannot emphasize enough the benefit of seeing patients with dermatitis in the clinic with an equally experienced and compassionate nurse. Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Patients Receiving Breast Radiation Therapy: Results of a Randomized TrialInternational Journal of Radiation Oncology, Biology, PhysicsVol. 90Issue 4PreviewWe wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study (Boström et al, Radiother Oncol 2001;59:257-265). Full-Text PDF Natural Oil-Based Emulsion Containing Allantoin Versus Aqueous Cream for Managing Radiation-Induced Skin Reactions in Patients With Cancer: A Phase 3, Double-Blind, Randomized, Controlled TrialInternational Journal of Radiation Oncology, Biology, PhysicsVol. 90Issue 4PreviewTo investigate the effects of a natural oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation-induced skin reactions. Full-Text PDF

Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call