Archives of Breast Cancer (Mar 2022)
Assessing Honey Jell ® as a treatment for reducing Cancer-related fatigue in breast cancer patients undergoing Radiotherapy: Double blind Phase III clinical trial
Abstract
Background: Cancer-Related Fatigue is one of the most common complaints among cancer patients, which is experienced by 50-90% 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. Objective: We aimed to assess Honey Jell ®on reducing Cancer-related Fatigue among breast cancer patients undergoing cancer treatment. Method: The current study was a 9-week, double-blind, randomized phase III clinical trial, which was carried out on 40 breast cancer patients at the Cancer Institute of Iran. Study participants were randomly allocated into each arm of study 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, 2, and 4 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 arms of study during the study period using the T-test. Results: Mean of fatigue score for cases and controls was 39.80 (±9.6) and 38.4 (±11.1) at the baseline (P value= 0.698). It reduced to 31.55 (±6.08) for the case group in the 2nd week, while for controls, it was 35.55 (±8.2) (P=0.041). The mean score of fatigue continuously reduced to 30.65 (±6.86) in the fourth week of study in cases that were considerably lower than controls (36.05±5.20) (P=0.024). The mean score of CRF in the case group increased again and reached to 31.80 (±6.91) four weeks after the end of the study, while it was almost unchanged for controls (36.64±6.13) and the observed difference was not statistically significant (P=0.148). Conclusion: Honey Jell ®could be considered as an effective treatment to alleviate Cancer-Related Fatigue. However, more studies are required in this regard.