Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C15-C26- Malignant neoplasms of digestive organs
Conditions
Interventions
Intervention1: 1% Topical diclofenac gel: Twice daily topical application 1 gm (2 fingertip units) on both surfaces of both hands
Control Intervention1: Placebo gel: Matched placebo (same colour, cons
Sponsors
Indian Association of Supportive Care in Cancer
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of topical diclofenac with placebo in preventing clinically significant hand foot syndrome [HFS] (incidence of National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0 grade 2 or higher HFS)Timepoint: Baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of topical diclofenac with placebo on: 1. Incidence of NCI CTCv5.0 all grade HFS 2. Time to develop grade =2 HFS (from start of capecitabine) 3. Patient-reported outcomes (PROs) (HFS-14 questionnaire) 4. Adherence with diclofenac/ moisturiser application (self-reported) 5. Capecitabine dose reductions, delays and cessation due to HFS (number of patients with dose modifications due to HFS) 6. Safety profile (NCICTCv5.0 all grade HFS)Timepoint: Baseline and 12 weeks;To correlate the occurrence and severity of HFS with COX-2 levels (Serum COX-2 levels) and polymorphism of DPPD enzymeTimepoint: Baseline and 12 weeks | — |
Countries
India
Contacts
Public ContactAtul Batra
AIIMS, New Delhi
Outcome results
None listed