Effects of “compound Ma-ol-asal" syrup on cancer-related fatigue in gastrointestinal (GI) cancer patients who are undergoing chemotherapy

Determination of the effect of “compound Ma-ol-asal" syrup on cancer-related fatigue in gastrointestinal (GI) cancer patients who are undergoing chemotherapy

A randomized, double blinded, controlled clinical trial with a parallel group, phase 3

The sample cases are the patients with GI cancer referring to oncology and chemotherapy departments of Tohid hospital of Sanandaj who have symptoms of cancer-related fatigue. In order to blind the investigator, medications are named as "A" for “compound Ma-ol-asal" syrup and B for placebo. The patients don't aware of the type of drug she or he is assigned to. . In the first visit, consent forms and questionnaires of the fatigue severity based on Visual Analogue Fatigue Scale (VAS), Fatigue Severity Scale (FSS ) and the Cancer Fatigue Scale (CFS) are completed. After two weeks, patients are followed up by phone and after 4 weeks, patients are re-visited and questionnaires of fatigue severity will be completed again.

Inclusion criteria: 1.Age between 18- 70 years old; 2. GI cancer (pathologically diagnosed).3.Undergoing chemotherapy 4. Hemoglobin level at least 10g/dl Exclusion criteria: 1. Heart disease with unstable conditions 2. Liver disease with unstable conditions .3. Positive history of hypersensitivity to each component of the “compound Ma-ol-asal" syrup., 4. Serious accompanying disease. .

Group A: patients with GI cancer-related fatigue receiving “compound Ma-ol-asal" syrup, 10 cc three times daily. Group B: patients with GI cancer-related fatigue receiving placebo, 10 cc three times daily.

1. The mean of score of "Visual Analogue Fatigue Scale", 2.The mean of score of "Fatigue Severity Scale", 3. The mean of score of "The Cancer Fatigue Scale"

In this study, the restricted randomization method of block randomization is used. Blocking is used to balance the number of samples assigned to each of the study groups. The randomization method was performed using balanced block randomization and in the form of 4 blocks using the computer. Each drug is labeled with a number from 1 to 120. Patients were divided into two groups for the trial: the first group (60 people) was the intervention group and the second (60 people) was the control group (placebo group). Both groups were equally divided in terms of characteristics and coordinated conditions. The control group is assigned to "A" and the intervention group to "B", and then these two groups are divided into 6 blocks of 4: (1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) AB BA, (6) BAAB . These blocks are randomly stacked together by a computer to form a chain of random groups (e.g. B B A A A A B B A B A B B A B A A B B A B A A B ) Patients then enter these groups in the order of enrollment. For randomization, a randomization tool for random sequence software called Random allocation software is used. In addition to simple randomization, this software is also able to generate random sequences by the block generation method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Jollab or placebo bottles are produced with the same shape and color and after coding with a random sequence, each of the random sequences created is recorded on a label. The labels are stuck on Jollab or placebo bottles. Participants will receive the labeled bottles

In this study, both Jollab syrup and placebo are made by the pharmacist in the laboratory and dumped and coded in similar bottles that only the pharmacist knows about the codes and in the same way it will be given to researchers and basis on randomization finally for participants both so the researcher and the participant are blinded.

The study has not started yet, and the progress of the work and the data cannot be predicted so a decision will be made after the completion of the project.