The Effects of Synbiotic Supplementation on Serum Anti-Inflammatory Factors in the Survivors of Breast Cancer with Lymphedema following a Low Calorie Diet: A Randomized, Double-Blind, Clinical Trial

Abstract

Background and Aim

Breast cancer-related lymphedema (BCRL) is a treatment-related inflammatory complication in breast cancer survivors (BCSs). This study was aimed to evaluate the effect of synbiotic supplementation on serum concentrations of IL-10, TGF-β, VEGF, adiponectin, and edema volume among overweight or obese BCSs with lymphedema following a low-calorie diet (LCD).

Method

In a randomized double-blind, controlled clinical trial, 88 obese and overweight BCSs women were randomized to synbiotic supplement (n = 44) or placebo (n = 44) groups and both groups followed an LCD for 10 weeks. Pre- and post-intervention comparisons were made regarding the anti-inflammatory markers which included IL-10, TGF-β, VEGF, adiponectin, edema volume, and anthropometric measurements. Also, the same factors were analyzed to find inter-group disparities.

Results

There were no significant differences among participants in the baseline, except for IL-10 and adiponectin. Post-intervention, no significant differences were observed regarding the anti-inflammatory markers, including IL-10, VEGF, adiponectin, and TGF-β between the groups. After 10 weeks of intervention edema volume significantly decreased in the synbiotic group; additionally, anthropometric measurements (body weight, BMI, body fat percent, and WC) decreased in both groups significantly (P < 0.001 and P < 0.005; respectively).

Conclusion

Synbiotic supplementation coupled with an LCD in a 10-week intervention had beneficial effects on increasing the serum TGF-β, IL-10, and adiponectin levels in women with BCRL. It also reduced arm lymphedema volume. Therefore, synbiotic supplementation can be effective in improving health status in BCRL patients.

Acknowledgments

We would like to gratefully thank the participants for their support in the study. We are also thankful to Seyed-khandan rehabilitation Center and Zist Takhmir Company for their assistance in this study.

Conflict of Interest Statement

The authors report no conflict of interest.

Author Contributions

MZ, AST, and SHH provided study concepts and designed the study. AST, SHH, HE, ZS, and MI helped in data acquisition. MZ checked quality control of data and algorithms. LJ, MZ, AST, SV, and MN took part in data analysis, interpretation, and statistical analysis. AST, MZ, ShJ and HE contributed to manuscript preparation, editing, and review.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This study was supported by Iran University of Medical Sciences (IUMS) with 96-02-27-31431 grant number.