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



Rezaeizadeh H¹ ; Najafi M² ; Hashemi FA³ ; Jafari F^{3, 4} ; Jahanbakhshi A² ; Haddad P³ ; Aghili M³ ; Kalaghchi B³ Show Affiliations
Source: Archives of Breast Cancer Published:2022

Abstract

Background: Cancer-Related Fatigue (CRF) 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. 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 9-week, double-blind, randomized phase III clinical trial, which was carried out on 40 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, 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 the study groups during the study period using the T-test. Results: Mean of fatigue score for intervention and control cases was 39.80 (±9.6) and 38.4 (±11.1) at the baseline (P-value= 0.698). The figure reduced to 31.55 (±6.08) for the intervention 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 in the intervention cases, which was considerably lower than the figure for controls (36.05±5.20) (P=0.024). The mean score of CRF in the intervention group increased 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. Copyright © 2022.