Sepideh Elyasi1,2, Sara Rasta3,4, Ali Taghizadeh-Kermani3,5, Sare Hosseini6. 1. Department of Clinical Pharmacy, Faculty of Pharmacy, University of Medical Sciences, Mashhad, Iran. 2. Associate Professor of Clinical Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. 3. Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 4. Radiotherapy Oncologist, Mashhad University of Medical Sciences, Mashhad, Iran. 5. Associate Professor of Radio-Oncology, Mashhad University of Medical Sciences, Mashhad, Iran. 6. Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Hosseinis@mums.ac.ir.
Abstract
PURPOSE: In this clinical trial, we evaluated Alpha® ointment efficacy in prevention of capecitabine induced hand-foot syndrome (HFS) in patients with gastrointestinal or breast cancers, for the first time. METHODS: During this pilot, randomized, triple-blinded, placebo-controlled clinical trial, the effect of Alpha® ointment (Lawsonia inermis 3 g and Curcuma longa 0.15 g/ 30 g) was assessed. It was applied on the palms and the soles, two times daily starting at the first day of chemotherapy for 4 consecutive courses. The severity of HFS was assessed at the end of the chemotherapy courses based on World Health Organization (WHO) scale and scored between 0-4. RESULTS: Ninety eligible patients were included randomly in the treatment or placebo group. Median WHO HFS grade was not significantly different between the two groups, during the follow-up period (P > 0.05). In the weekly assessment, the scores increased meaningfully in both the placebo and treatment groups, but there was a delay in HFS occurrence and deterioration in Alpha ointment group based on post hoc analysis. CONCLUSION: Administration of Alpha® ointment containing henna and curcumin could not significantly prevent capecitabine induced HFS during 4 courses of treatment, but can somewhat delay its occurrence in patients with gastrointestinal or breast cancer.
PURPOSE: In this clinical trial, we evaluated Alpha® ointment efficacy in prevention of capecitabine induced hand-foot syndrome (HFS) in patients with gastrointestinal or breast cancers, for the first time. METHODS: During this pilot, randomized, triple-blinded, placebo-controlled clinical trial, the effect of Alpha® ointment (Lawsonia inermis 3 g and Curcuma longa 0.15 g/ 30 g) was assessed. It was applied on the palms and the soles, two times daily starting at the first day of chemotherapy for 4 consecutive courses. The severity of HFS was assessed at the end of the chemotherapy courses based on World Health Organization (WHO) scale and scored between 0-4. RESULTS: Ninety eligible patients were included randomly in the treatment or placebo group. Median WHO HFS grade was not significantly different between the two groups, during the follow-up period (P > 0.05). In the weekly assessment, the scores increased meaningfully in both the placebo and treatment groups, but there was a delay in HFS occurrence and deterioration in Alpha ointment group based on post hoc analysis. CONCLUSION: Administration of Alpha® ointment containing henna and curcumin could not significantly prevent capecitabine induced HFS during 4 courses of treatment, but can somewhat delay its occurrence in patients with gastrointestinal or breast cancer.
Authors: Omar A Habbal; Ali A Al-Jabri; Abdulghaffar H El-Hag; Zahra H Al-Mahrooqi; Nasser A Al-Hashmi Journal: Saudi Med J Date: 2005-01 Impact factor: 1.484