A pilot study of lactoferrin in patients with self-reported, chemotherapy-induced taste and smell abnormalities.

Abstract

e21643 Background: Taste and smell abnormalities (TSA) are common in patients receiving chemotherapy and may lead to food avoidance, altered nutritional intake, treatment delay or withdrawal, diminished socialization and impaired overall quality of life. Lipid peroxidation of mucosal cell membranes in the oral cavity is one cause of TSA and lactoferrin (LFN), an iron-binding protein normally present in saliva, is an effective scavenger of lipid byproducts that can decrease metallic flavor in healthy volunteers. Methods: Eligible patients with colorectal or pancreatic adenocarcinoma and self-reported TSA while on an oxaliplatin-containing chemotherapy regimen were treated with LFN 250mg three times daily for 4 weeks and then followed for an additional 4 weeks off study drug. A second identical IRB-approved pilot trial enrolled patients with solid tumors, lymphoma or myeloma with self-reported TSA while receiving chemotherapy. The primary outcome was the change in self-reported TSA following 4 weeks of LFN as measured by a validated taste and smell questionnaire (TSQ) consisting of taste (score 0-10) and smell (score 0-6) subscales, which are combined to yield a total composite score (0-16, 0 = no TSA). The TSQ was assessed at 0, 4 and 8 weeks along with the FAACT (FACT–G + anorexia subscale), salivary protein and metals analyses, and the Brief Smell Identification test (B-SIT). Results: 26 total pts were enrolled (14 Males; mean age 60.5 years; range 32-79), and 19 and 17 pts remained on study with analyzable data at 4 and 8 weeks. Baseline mean taste, smell and composite TSQ scores for the 26 enrolled patients were 6.5, 3.1 and 9.6 units. After 4 weeks of LFN treatment, the mean overall TSQ score improved by 1.7 units (p = .018) while the taste and smell subscales improved by 0.6 (p = .062) and 1.1 units (p = .042) respectively. At 8 weeks, the mean TSQ score improved from baseline by 3.8 units (p < .0001) while the taste and smell subscales improved by 1.9 (p = .001) and 1.8 (p = .003) units. No significant change from baseline was recorded in the FAACT or the B-SIT at 4 or 8 weeks. Conclusions: These pilot data suggest that further evaluation of LFN in patients with self-reported TSA is warranted. A randomized trial is in development. Clinical trial information: NCT01941810, NCT01596634.