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Clinical Trials/CTRI/2021/01/030592
CTRI/2021/01/030592
Active, not recruiting
Phase 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 enrollmentTBD
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ConditionsHealth Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: C15-C26- Malignant neoplasms of digestive organs

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: C15-C26- Malignant neoplasms of digestive organs
Sponsor
Indian Association of Supportive Care in Cancer
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Indian Association of Supportive Care in Cancer

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

Outcomes

Primary Outcomes

Not specified

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