| CTRI Number |
CTRI/2024/09/074530 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Henna gel for the prevention of capecitabine-induced hand-foot syndrome in Cancer patients |
|
Scientific Title of Study
|
Formulation and evaluation of topical preparation of Lawsonia inermis L. (Lythraceae) for the prevention of capecitabine induced hand-foot syndrome in Cancer patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Jayanthi |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of Pharmacology JIPMER Puducherry
India
Pondicherry PONDICHERRY 605006 India |
| Phone |
9442395291 |
| Fax |
|
| Email |
drjayanthi2008@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M Jayanthi |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of Pharmacology JIPMER Puducherry
India
Pondicherry PONDICHERRY 605006 India |
| Phone |
9442395291 |
| Fax |
|
| Email |
drjayanthi2008@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
B Bhanupriya |
| Designation |
PhD Scholar |
| Affiliation |
JIPMER |
| Address |
Department of Pharmacology JIPMER Puducherry
India
Pondicherry PONDICHERRY 605006 India |
| Phone |
9944967173 |
| Fax |
|
| Email |
bhanupriyabalaramane@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural Research Fund
JIPMER, Dhanvanthri nagar, Gorimedu, Pondicherry-605009 |
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural Resarch Fund |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| B BHANUPRIYA |
JIPMER |
Department of Medical
Oncology, Regional
Cancer Centre.
Pondicherry
PONDICHERRY Pondicherry PONDICHERRY |
9944967173
bhanupriyabalaramane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum, (4) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Henna Gel |
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. |
| Comparator Agent |
Topical Placebo gel |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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).
|
|
| ExclusionCriteria |
| Details |
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).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of topical henna preparation on the prevention of capecitabine induced hand foot syndrome in cancer patients. |
Every three weeks for nine weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |