Effect of Royal Jelly supplementation on anthropometric indices, fatigue, appetite, inflammatory indices and mortality in patients with colon cancer: a randomized controlled trial study

Investigating the changes of anthropometric indices, fatigue, appetite, inflammation and mortality by supplementing with Royal Jelly in colon cancer patients

A controlled trial study with a control group, with parallel groups, one-sided blind, randomized, phase 2-3 and on 52 patients. Simple randomization is with a sealed envelope and by informing from the randomization center (call center).

In this study, 52 patients referred to Shohada-e-Tajrish and Ayatollah Taleghani hospitals, who have the inclusion criteria and no exclusion criteria, are included as a sample, after evaluating the desired variables in them and filling the required questionnaires, they will receive Royal Jelly or placebo supplement for four weeks. The participants are unaware of the type of supplement received.

Inclusion criteria: age between 18 to 65 years, diagnosed colon cancer in the second or third stage and need for surgery. Exclusion criteria: pregnancy, immunodeficiency, disorder of respiratory, cardiovascular, renal and hepatic system, serum hemoglobin level less than 8g/dL.

The study has two intervention and control groups. The intervention group will receive two Royal Jelly capsules daily and the control group will receive two placebo capsules filled with starch filler. The duration of the intervention is 4 weeks.

Weight, height, interleukin-6, C Reactive Protein (CRP) and Tumor Necrosis Factor-a (TNF-α) serum levels, quality of life, fatigue variable, anthropometric variable

In this study, patients are divided into 2 intervention groups (as a group receiving royal jelly supplement) and a control group (as a group receiving placebo). A simple random division method is used to randomly assign patients to two groups. The randomization unit is individual. Entry into the study is done after evaluating and meeting the criteria for entering the study and after the patient's consent using random numbers method made by computer and by a person other than the main researcher in a place outside the sampling site. These random numbers created by the computer indicate the entry of each person into the intervention or control group (according to whether the random number is even or odd for each patient), which is provided to the researchers at the location of the sampling by phone. Based on the number received from the control center, the sampler directs the patient to one of the intervention or control groups. Actually, when a new person enters, a random number is created for him and based on this number, the person enters one of the groups.

The participants of the project are unaware of how to assign the numbers of the sealed envelopes to the intervention substance and the placebo, and based on whether the selected number is even or odd for each person, the desired substance, which is the same in terms of shape, color and packaging between the intervention substance and the placebo, will be provided to the participant.