Formulation and evaluation of topical preparation of Lawsonia inermis L. (Lythraceae) for the prevention of capecitabine induced hand-foot syndrome in Cancer patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- The effect of topical henna preparation on the prevention of capecitabine induced hand foot syndrome in cancer patients.
Study Overview
Brief Summary
All the patients will be explained about risks and symptoms of HFS and risk and benefits of the study. Patch test will be done under the supervision of consultant/dermatologist for the patients who are intended to be included in the study to detect any allergy to topical henna preparation and placebo preparation. The topical preparations, both henna and placebo, will be applied on the dorsal aspect of each arm (1*1 cm area) and patients will be kept under observation for 30 minutes. Patients will be asked for any irritation/allergy/sensation. If the patients do not develop any allergy or irritation the patients will be included in the study. Baseline demographic variables, type and stage of cancer, chemo-therapeutic drugs and their doses will be recorded from the case record as well as by interviewing of the patient. They will be provided an HFS diary in Tamil and will be asked to fill it daily. Based on randomization, control group will receive placebo preparation and the treatment group will receive topical preparation containing henna. 10 ml of blood sample will be taken under aseptic precautions to do the blood investigations at baseline, at the end of 9 weeks for the evaluation of inflammatory markers. The study participants will be given six packs of topical preparation containing henna. After washing hands and feet with soap, treatment groups will be asked to apply topical preparation containing henna twice daily. Two fingertip unit of topical preparation will be applied on the soles and one fingertip unit on the palms from the first day of chemotherapy with capecitabine and continued consecutively for 9 weeks. The placebo produced identically, containing all ingredients of henna topical preparation except henna will be given to the control group in the same manner. The total capecitabine dose will be almost identical for all patients per cycle. Patients should not receive any other medication or supportive measure for HFS prevention during the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of both gender older than 18 years.
- •Patients attending Regional Cancer Centre, JIPMER who are diagnosed with cancer (breast cancer, Colorectal cancer and stomach cancer).
- •Patients who are planned for capecitabine based chemotherapy regimen (1000-1250mg/m2 twice daily).
Exclusion Criteria
- •Patients who received capecitabine previously.
- •Patients with pre-existing peripheral neuropathy and other dermatological disorders Patients who are on low dose capecitabine regimen (less than 1000mg per m2 twice daily).
Outcomes
Primary Outcomes
The effect of topical henna preparation on the prevention of capecitabine induced hand foot syndrome in cancer patients.
Time Frame: Every three weeks for nine weeks
Secondary Outcomes
- The time taken for the appearance of capecitabine induced hand foot syndrome in cancer patients.(Every three weeks for nine weeks)
- The adverse reactions of topical preparation of henna in cancer patients with capecitabine induced hand foot syndrome.(Every three weeks for nine weeks)
Investigators
Dr M Jayanthi
JIPMER