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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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