Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Concurrent Use of Crocin During Chemoradiation for Esophageal Squamous Cell Carcinoma

Abstract

Crocin is the major active carotenoid of saffron (Crocus sativus L.). Its pluripotent effects have led to a growing body of literature investigating its antitumor properties as well as its diverse potentials for mood stabilization, normal tissue protection, and inflammation reduction; However, there is a gap in clinical trials testing this substance in cancer patients. In this randomized, double-blind, placebo-controlled clinical trial, patients with newly diagnosed esophageal squamous cell carcinoma were randomly assigned to either 30 mg/day of crocin or placebo, prescribed during the neoadjuvant chemo-radiotherapy. The primary endpoints were pathological response and toxicity, and secondary endpoints were depression and anxiety levels and survival analysis.

Graphical Abstract

Keywords:

• Esophageal squamous cell carcinoma
• chemotherapy
• radiotherapy
• crocin
• carotenoids
• anxiety
• depression

Acknowledgments

The present research is a part of Pharm-MD thesis, approved by School of Pharmacy, Mashhad University of Medical Sciences. We thank the study participants for their kind cooperation and helpful advice.

Ethical approval

This trial was registered in the Iranian Clinical Trial Registry (IRCT20130418013058N7). The study protocol was approved by the Ethics Committee of Mashhad University of Medical Sciences (approval code: IR.MUMS.fm.REC.1396.302), and was conducted according to the Declaration of Helsinki. Undersigned informed consent forms were obtained from all patients prior to the enrollment.

Author contributions

RS, SAM, AF, and SS contributed in design, conception, and draft of the manuscript. NE and MD contributed in data collection. SAJ and SS developed the statistical analysis. SAJ, NE, MD, and NV contributed in drafting of the manuscript. MD provided the graphical abstract. SAMo supervised the study. All authors approved the final version for submission.

Disclosure statement

In manufacturing crocin tablets for the pharmaceutical industry, Dr. Seyed Ahmad Mohajeri is part of the knowledge-based corporation. The other authors have no conflicts of interest to declare.

Data availability statement

The data sets used and/or analyzed during the current study are available from the corresponding authors per request.

Correction Statement

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

Additional information

Funding

The project was funded by Mashhad University of Medical Sciences [960680 to Dr Seyed Ahmad Mohajeri].