Evaluation of the herbal combination of Cichorium inyubus, Trigonella foenum-graecum and Foeniculum vulgare in the prevention of cancer-induced cachexia/anorexia in solid tumours’ patients: a randomized, double-blinded, placebo-controlled clinical trial

The evaluation of herbal combination in the body mass index, actual body weight, arm circumference, triceps muscle circumference, Anderson, Edmonton, FAACT criteria of patients with solid tumor in comparison with placebo

Two arms parallel groups, randomized trial with placebo, controlled-blinded group, and outcome assessment in 60 recruited patients between July 2018 till May 2019.

The study will be carried out in the clinic of Seyedoshohada hospital, Isfahan. The investigator will recruit the patients and devote a special code to each participant. Then, the herbal combination or placebo will be given blindly to patients for four weeks. According to the study's endpoints, patients will be followed at baseline and after four weeks of herbal combination consumption.

Inclusion criteria: All adult patients with advanced solid malignant tumour who have cancer-induced anorexia or weight loss and received high doses of megestrol with no hepatic-, nephrotic- and gastrointestinal disorders. Exclusion criteria: Patients with a known history of sensitivity to the study herbs, cardiovascular disorder, diabetes, recent major surgery, corticosteroids consumption or alcohol abuser.

Patients with solid tumours who will be the candidate for receiving megestrol by a dose of 40 mg QID will be identified by physicians and investigator. The herbal combination and placebo which will be provided by Dineh company by the dose of 1 tablet three times a day for eight weeks in both patients and control group will be considered.

The considered outcomes will be included the quality of life assessment, the criteria for anorexia and weight gains such as Edmonton, Anderson, FAACT criteria as well as anthropometrics criteria such as the increase in body weight, arm muscle circumference and triceps.

The method of sampling is based on Blocked randomization. In this method, the information about the number of treatment group, block size (multiples of group number) and the whole number of patients will be entered into internet software ( https://www.sealedenvelop.com) and according to obtained codes, the type of drugs for each patient will be determined. In this study, the number of treatment groups will be 2 groups and we will use 4-containing blocks. The predicted patients' sample size will be allocated randomly according to patients' order of recruitment and special code allocation into two groups of placebo and intervention.

In this study, we will use the doubled-blinded randomization in which both investigator and patients will be blinded. The main investigator will allocate the concealed code to the herbal tablet or placebo according to random numbers and will provide them to investigators in charge of sampling. The investigators who are in charge of sampling will be given the herbal tablet or placebo to the patients numerically and in a blind way.

All data can be shared

Starting 6 months after publication

People working in academic institutions

All required analyses can be applied

Azadeh Moghaddas, Clinical Pharmacy Department, School of Pharmacy, Isfahan University of Medical Sciences, Hezarjarib street, Isfahan. moghaddas@pharm.mui.ac.ir

After sending a request, we will call the related person and the data will be revealed in less than one week.