CTRI/2021/01/030592Active, not recruitingPhase 3
Randomized double-blind, placebo-controlled study of topical diclofenac in prevention of hand-foot syndrome in patients receiving capecitabine - D-TORCH
Indian Association of Supportive Care in Cancer0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Age = 18 years
- •2.Starting capecitabine for breast and GI malignancies, either in adjuvant/neoadjuvant or palliative setting
- •3.Commencing capecitabine at a dose of =1000mg/m2 twice daily every 2 out of 3 weeks as single-agent chemotherapy
- •4.Life expectancy greater than 12 weeks
- •5.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •6.Study treatment both planned and able to start within 14 days of randomisation
- •7.Willing and able to comply with all study requirements, including treatment (applying diclofenac gel), timing and/or nature of required assessments
- •8.Signed, written informed consent
Exclusion Criteria
- •1.Pre-existing grade 2 or higher neuropathy confounding assessment of HFS
- •2.Other dermatologic condition, that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
- •3.Concurrent or planned use of pyridoxine
- •4.Allergy or anaphylactic reactions with NSAIDs
- •5.History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- •6.Patients receiving oral or topical NSAIDs for other conditions
- •7.Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
- •8.Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
- •9.Pregnant or lactating women
Investigators
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