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 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•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

•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

发起方

Indian Association of Supportive Care in Cancer