The effect of "Maoljobon ( whey)" on Cancer patients with chemotherapy_ induced "hand and foot syndrome" and their quality of life

Improving the quality of life of patients

Triple blinded intervention Randomize clinical Trial -triple blinded - controlled Simple randomization of available patients Phase 3

From the hospitals and offices of oncologists in Qom, the files of all cancer patients who have sought treatment for chemotherapy drugs, including Capecitabine Dejar Syndrome, have been extracted, and eligible patients are divided into intervention and control groups. Demographic information, type and stage of cancer of patients will be recorded.

معیارهای ورود: تمام بیماران بالای 18 سال مبتلا به سندروم دست و پای ناشی از شیمی درمانی، از جمله داروی Capecitabine، که رضایت به شرکت در مطالعه دارند. معیارهای عدم ورود: بیماران مبتلا به دیگر ضایعات پوستی- وجود عفونت- بیماری التهابی روده- سابقه حساسیت شدیدبه شیر Inclusion criteria: All patients over 18 years of age with chemotherapy-induced hand and foot syndrome, including Capecitabine, who agree to participate in the study. Criteria for not entering: Patients with other skin lesions - Infection - Inflammatory bowel disease - History of severe milk allergy

The intervention group consumes 15 grams of malt powder twice a day, in the morning and in the evening, which should be dissolved in 100 cc of lukewarm boiled water, and sip, and eat something until one hour after consumption. Do not use. Mercury will be used for 6 weeks and 2 days. At the same time, both control and intervention groups, 20% glycerin ointment; Use topically.

Common Terminology Criteria for Adverse Event, Edition 5, including the definition of three degrees of the syndrome, grades 1, 2, and 3, to assess the degree of lesion Pain rate, Evaluation of redness and scaling of skin lesions Evaluation of burning, itching and, numbness of skin lesions

In the first step, the groups are written as groups A and B. A lottery is then drawn between the two groups to determine which letter is in the intervention group and which is in the control group. In the second step, 60 numbers, from one to 60, are written on paper and completely closed so that they are not visible and are thrown into a container. Then, in the third step, a person will announce that the patients will choose the intervention or control group, then pick up a number from the container and read it and take notes in the group that announced it. This is done 30 times without substitution until all the people in the announced group are identified, then the remaining 30 numbers are assigned to the second group. Finally, when patients come to the clinic, each patient has a number from inside a container that contains 60 numbers from one to 60 and is written on paper and is not visible, and gives it to the therapist, then the therapist opens the number paper and Looks at the list of groups. The selected number belongs to each group. The patient is placed in that group and this is done up to 60 times to complete the groups.

During the study and sampling, the therapist, researcher and patients will not know the type of group (control or intervention) and try to invite patients to visit at a distance so as not to meet each other and not be informed about the content of the treatment. The distribution of medicine according to the group list will be done by one of the staff of the center who is not involved in the examination and collection of information. After collecting the data, the analyzers will not know the patient group

Data will be sent on request by researchers.

After printing the study results

researchers

For systematic review studies or meta-analysis

Dr. Majid Asghari

Correspondence by email with the project manager