| CTRI Number |
CTRI/2022/10/046534 [Registered on: 17/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Urea cream to prevent Capecitabine related Hand Foot Syndrome: a Randomized Controlled trial |
|
Scientific Title of Study
|
Urea cream as prophylaxis for Capecitabine induced Hand Foot Syndrome: a Randomized phase 3 trial at a tertiary care hospital in South India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri R Nair |
| Designation |
Resident, DM Medical Oncology |
| Affiliation |
Madras Medical College |
| Address |
Department of Medical Oncology, Madras Medical College, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9778116159 |
| Fax |
|
| Email |
g3nair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S G D Gangadharan |
| Designation |
HOD,Department of Medical Oncology |
| Affiliation |
Madras Medical College |
| Address |
Department of Medical Oncology, Madras Medical College, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9841096885 |
| Fax |
|
| Email |
sgd8gangadaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri R Nair |
| Designation |
Resident, DM Medical Oncology |
| Affiliation |
Madras Medical College |
| Address |
Department of Medical oncology, Madras Medical College,Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9778116159 |
| Fax |
|
| Email |
g3nair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras Medical College, Chennai, 600003 |
|
|
Primary Sponsor
|
| Name |
no sponsor |
| Address |
no sponsor |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Dr Gayathri R Nair |
Madras Medical College |
Department of Medical Oncology
Chennai
TAMIL NADU |
9778116159
g3nair@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
12% urea cream |
Patients will be instructed to use 12 percent urea cream on both hands and feet, three times a day as well as after washing hands for 6 weeks |
| Comparator Agent |
observation |
Patients will be kept on observation for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with gastrointestinal malignancies of breast cancer initiating capecitabine treatment at a dose of at least 1000mg/m2 twice daily as monotherapy or combination therapy, ECOG PS less than 3, adequate bone marrow function |
|
| ExclusionCriteria |
| Details |
Patients with any dermatological toxicity other than alopecia that has not resolved, creatinine clearance of <30ml/min as per Cockcroft gault formula |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the efficacy of urea cream vs placebo to
prevent HFS of any grade within a 6-week period. |
at baseline, 3 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time to development of HFS
time to capecitabine dose interruption,
evaluation of capecitabine dose intensity
quality of life analyses |
at baseline, 3 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
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 3 |
|
Date of First Enrollment (India)
|
20/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Hand Foot Syndrome(HFS) is a well known adverse effect of Capecitabine, with rates ranging between 22%-735, as per various studies. Although not life threatening, it is associated with severe discomfort and impairment of quality of life, which is why addressing HFS is important. There is no well established prophylaxis for HFS. Our study aims to assess the efficacy of Urea cream to prevent Capecitabine induced HFS. Patients will be randomized into 2 arms. Patients in Arm A will be instructed to used 12% urea cream three times daily on hands and feet, as well as after washing. Patients in Arm B will be kept on observation. Primary objective of the study is to assess the efficacy of urea cream vs placebo to prevent HFS of any grade within a 6-week period. Secondary objectives include time to development of HFS, time to capecitabine dose interruption, evaluation of capecitabine dose intensity, quality of life analyses. |