Urea cream to prevent Capecitabine related Hand Foot Syndrome: a Randomized Controlled trial

Phase 3

Completed

Conditions: Malignant neoplasms of digestive organs, (2) ICD-10 Condition: C50-C50||Malignant neoplasms of breast,

Registration Number: CTRI/2022/10/046534

Lead Sponsor: no sponsor

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 228

Inclusion Criteria

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.

Exclusion Criteria

Patients with any dermatological toxicity other than alopecia that has not resolved, creatinine clearance of <30ml/min as per Cockcroft gault formula.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to assess the efficacy of urea cream vs placebo to	at baseline, 3 weeks and 6 weeks
prevent HFS of any grade within a 6-week period.	at baseline, 3 weeks and 6 weeks

Secondary Outcome Measures

Name	Time	Method
time to development of HFS	time to capecitabine dose interruption,

Trial Locations

Locations (1): Madras Medical College
🇮🇳
Chennai, TAMIL NADU, India
Madras Medical College
🇮🇳Chennai, TAMIL NADU, India
Dr Gayathri R Nair
Principal investigator
9778116159
g3nair@gmail.com