Oral Propolis, Nutritional Status and Quality of Life with Chemotherapy for Breast Cancer: A Randomized, Double-Blind Clinical Trial

Abstract

Chemotherapy-induced side effects include an impaired nutritional status and reduced quality of life in patients. The contribution of propolis, as a co-adjuvant nutritional supplement in cancer treatment, is suggested due to its functional characteristics and biological activities such as antitumoral activity, DNA protection, free radicals scavenging, and immune stimulation; however, clinical trials to support these effects in cancer patients are necessary. This is a randomized, double-blind, placebo-controlled clinical trial to assess the effect of propolis vs. placebo on the nutritional status and quality of life in patients diagnosed with breast cancer who are receiving chemotherapy (No. IRCT2016062828679N1). A total of 60 patients from the Oncology Clinic at Tohid Hospital, Sanandaj, Iran were randomized to receive propolis (250 mg/two times per day for three months) or a placebo. After three months of intervention, energy intake of patients who received propolis increased significantly compared to placebo group (p = 0.000). The quality of life also showed significant improvements in patients receiving propolis, particularly with regards to emotional functioning (p = 0.03), global QoL functioning (p = 0.04), and financial difficulties (p = 0.01) compared to the control group. Propolis is suggested an adequate and safe therapeutic option to improve the nutritional status and quality of life in patients diagnosed with breast cancer receiving chemotherapy. However, more trials are needed in order to draw robust conclusions with regard to its efficacy in chemotherapy-induced side effects.

Acknowledgments

The authors would like to thank the Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences, Tehran, Iran, for financial support and also the Vice-Chancellor for Research, Kurdistan University of Medical Sciences, Sanandaj, Iran, for financial support.

Conflict of Interests

Authors declare that they do not have any conflict of interest relevant to the present manuscript.

Author Contributions

The author’s responsibilities were as follows: ND and SHD designed the research; VY and BG conducted the data collection; SD participated in the data collection and entry and did the experiments. YM analyzed the data. ND and VY wrote the manuscript; MEA was responsible for revising the manuscript. All authors approved the final manuscript and submission.

Ethics Approval and Consent to Participate

The Ethics Committee of Kurdistan University of Medical Sciences approved the protocol of the study. The researchers adhered to the principles of the Helsinki Declaration throughout the study and written informed consent was obtained from the patients. The protocol of the study was registered in the Iranian Registry of Clinical Trials (IRCT2016062828679N1).

Additional information

Funding

The present study received support from the Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences and the Vice-Chancellor for Research, Kurdistan University of Medical Sciences, Sanandaj, Iran, as a Joint research project