Abstract
Objective: The objective of the study was to evaluate the effects of IND02 (standardized Cinnamon bark extract) supplementation for the prevention of side effects of cancer chemotherapy in female patients with breast cancer.
 Methods: The study was conducted using double-blind, placebo-controlled design in 34 female breast cancer patients during the first 4 consecutive 21-day cycles of the standard chemotherapy regimen. The active treatment (IND02 capsules, 400 mg, one capsule, and thrice a day) or matching placebo was orally administrated in randomized (1:1 ratio) patients. The efficacy outcome measures were reduction in chemotherapy-induced weight loss, alopecia (hair fall), and other side effects. The safety outcome measures were hematology, ECG, vital signs, adverse event monitoring, and laboratory safety measurements.
 Results: The patients on the treatment with IND02 had shown significant protection from chemotherapy-induced severe weight loss (cachexia) and alopecia (reduced hair density and % hairs in the anagen phase, and increased % hairs in telogen phase) which was seen in the placebo group. IND02 treatment was found safe and well-tolerated during the study.
 Conclusion: Concomitant use of IND02 in breast cancer patients during breast cancer chemotherapy showed a clinical promise regarding efficacy and safety in preventing chemotherapy-induced weight loss and alopecia.
Highlights
The breast cancer is the second most common type of cancer after lung cancer worldwide (10.4% of all cancer incidence, both sexes counted) and the fifth most common cause of cancer death [1]
The effects of IND02 were evaluated during four chemotherapy cycles were followed
Effects on chemotherapy-induced weight loss The unpaired “t”-test of body weight data of the patient from the IND02 group was found to increased whereas that of the placebo group showed a decline in weight over the study period
Summary
The breast cancer is the second most common type of cancer after lung cancer worldwide (10.4% of all cancer incidence, both sexes counted) and the fifth most common cause of cancer death [1]. The treatment of cancer has relied primarily on the use of various forms of cytotoxic chemotherapy and radiation therapy. Most chemotherapeutic drugs target fast-dividing cells and mitosis (cell division) impairment. These interventions have had profound positive results on many hematological malignancies and a few solid tumors, especially germ cell and some childhood malignancies. In most cases, the effectiveness of cytotoxic treatments has been limited by the side and immuno-suppression, with susceptibility to opportunistic pathogens [3,4] which remained as the major obstacles for the successful clinical use [5]. Typical chemotherapy side effects include severe weight loss (cachexia), alopecia (hair loss), nausea, vomiting, diarrhea, loss of appetite, mouth soars (mucositis), anemia, cardiotoxicity, hepatotoxicity, and nephrotoxicity
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