Assessing Honey Jell® as a Treatment for Reducing Cancer-Related Fatigue in Breast Cancer Patients Undergoing Radiotherapy: Double Blind Phase III Clinical Trial

Background: Cancer-Related Fatigue (CRF) is one of the most common complaints among cancer patients, which is experienced by ۵۰-۹۰% of them. It can affect several physical, emotional, and social aspects of cancer patients' lives and reduce their quality of life. In recent decades, the number of studies has increased in this regard, and several different ways for CRF management have been introduced. We aimed to assess the effect of Honey Jell ® on reducing cancer-related fatigue among breast cancer patients undergoing cancer treatment. Methods: The current study was a ۹-week, double-blind, randomized phase III clinical trial, which was carried out on ۴۰ breast cancer patients at the Cancer Institute of Iran. The participants were randomly assigned to two groups by the Balanced-Block Randomization method. The study group received Honey Jell ® (natural product based on honey, royal jelly, and extract of Ziziphus zizyphus) while we used ordinary honey as a placebo for the control group. We assessed CRF at baseline, ۲ and ۴ weeks after the start of the study and four weeks after finishing the intervention using three different approaches. The mean score of fatigue was compared between the study groups during the study period using the T-test. Results: Mean of fatigue score for intervention and control cases was ۳۹.۸۰ (±۹.۶) and ۳۸.۴ (±۱۱.۱) at the baseline (P-value= ۰.۶۹۸). The figure reduced to ۳۱.۵۵ (±۶.۰۸) for the intervention group in the ۲nd week, while for controls, it was ۳۵.۵۵ (±۸.۲) (P=۰.۰۴۱). The mean score of fatigue continuously reduced to ۳۰.۶۵ (±۶.۸۶) in the fourth week in the intervention cases, which was considerably lower than the figure for controls (۳۶.۰۵±۵.۲۰) (P=۰.۰۲۴). The mean score of CRF in the intervention group increased ۳۱.۸۰ (±۶.۹۱) four weeks after the end of the study, while it was almost unchanged for controls (۳۶.۶۴±۶.۱۳) and the observed difference was not statistically significant (P=۰.۱۴۸). Conclusion: Honey Jell ® could be considered as an effective treatment to alleviate cancer-related fatigue. However, more studies are required in this regard.