Effect of Olanzapine on appetite, nausea, and vomiting in patients undergoing chemotherapy

Investigating the effectiveness of olanzapine in improving anorexia and weight gain in patients undergoing chemotherapy

A clinical trial with a control group with parallel groups, double-blind, randomized with random blocks by sealed envelope software phase 3 on 180 patients.

This study will be conducted in the hematology clinic of Taleghani Hospital, Tehran. 180 patients undergoing chemotherapy who meet the inclusion criteria will be included in the study after obtaining informed consent. Before starting the treatment, the weight of the patients is measured and recorded. Also, the state of anorexia and nausea of the patients will be evaluated. Patients are also measured for albumin and CRP levels. Participants are then randomly assigned to receive either olanzapine or placebo. The patients who will be assigned to two groups will be matched in terms of gender, age, and type of cancer. Patients in the first group will receive 2.5 mg of olanzapine daily for 12 weeks, and in the second group, they will receive 2.5 mg of placebo. After 12 weeks, the patients are examined again for weight, anorexia, nausea, albumin and CRP levels. This study will be conducted in a double-blind manner (participants and outcome assessor).

Inclusion criteria: anorexia, metastatic cancer of the stomach, liver, pancreas, colon, rectum, breast and lung, no use of olanzapine during the last year. Exclusion criteria: non-adherence to treatment, unwillingness to continue participating in the study

Patients in the first group will receive 2.5 mg of olanzapine daily for 12 weeks, and in the second group, they will receive 2.5 mg of placebo.

Anorexia, nausea, weight, albumin level, CRP level

Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block, two, four or six patients will be included in the study order. Random allocation of blocks of patients to two treatment groups receiving olanzapine and receiving placebo will be done through Sealed Envelope online software. By referring to https://www.sealedenvelope.com/simple-randomiser/v1/lists by specifying the total number of samples, the number of possible samples in each randomized block (2, 4 and 6 patients) randomization by online software is done For example, like the following output: block identifier block size sequence within block treatment 1 2 1 Group B 1 2 2 Group A 2 4 1 Group A 2 4 2 Group B 2 4 3 Group B 2 4 4 Group A 3 2 1 Group A 3 2 2 Group B ... which is the block number, the number of patients in the block, and the random assignment of each patient (with the corresponding number) to the treatment group. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis.

The study will be double-blind, so the outcome assessor does not know which group a patient is in. Also, regarding the blinding of the participants, the general process of the study will be explained to them, but the patients will not know which group they will be in and which intervention (placebo or drug).

Due to the complete presentation of the results based on the data in the text of the article, and the preservation of the raw data, there are no plans to publish it.

The study protocol and clinical study report will be made available to other researchers. Also, the statistical analysis map and the codes used in the analysis are provided to statistical experts

After the publication of the article

Researchers, professors and students in the field of medicine

In order to use and guide for further studies and if reference is mentioned

corresponding author Dr. Mina Norouzi noruzi2012@gmail.com

Sending the request email to the responsible author and mentioning the reason for the request and how to use the data