Status:
COMPLETED
Topical Diclofenac for Hand-Foot Syndrome Prevention in Colorectal and Gastric Cancer on Capecitabine (DICLO-HFS)
Lead Sponsor:
Gazi University
Conditions:
Colorectal Cancer
Gastric Cancer (GC)
Eligibility:
All Genders
18+ years
Brief Summary
Hand-foot syndrome (HFS) is a frequent adverse effect of capecitabine, presenting with redness, swelling, pain, and peeling of the skin on the palms and soles. These symptoms may impair daily activiti...
Detailed Description
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysesthesia, is a common dermatologic toxicity of fluoropyrimidine chemotherapy such as capecitabine. Clinically significant HFS (grade ≥2...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥18 years.
- Histologically or cytologically confirmed colorectal or gastric cancer.
- Planned capecitabine-based therapy (monotherapy or capecitabine plus oxaliplatin).
- Planned starting capecitabine dose ≥2,000 mg/m²/day.
- No prior systemic chemotherapy for the current malignancy.
- Ability and willingness to attend weekly clinical assessments during treatment.
- Written informed consent obtained.
- Exclusion Criteria
- Pre-existing dermatologic conditions affecting hands/feet (e.g., eczema, psoriasis) or peripheral neuropathy.
- Sjögren's syndrome involving hands or feet.
- Current or planned systemic NSAID use during capecitabine therapy.
- Use of other HFS prophylaxis at baseline (e.g., topical NSAIDs other than diclofenac, pyridoxine).
- Known hypersensitivity to diclofenac, aspirin, or other NSAIDs (e.g., history of asthma, urticaria, allergic reactions).
- Planned initial capecitabine dose \<2,000 mg/m²/day.
- Anticipated inability to comply with weekly follow-up assessments.
Exclusion
Key Trial Info
Start Date :
July 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT07177560
Start Date
July 30 2023
End Date
February 28 2024
Last Update
September 17 2025
Active Locations (2)
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1
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
2
Gazi University
Ankara, Turkey (Türkiye)