Topical Diclofenac for Hand-Foot Syndrome Prevention in Colorectal and Gastric Cancer on Capecitabine (DICLO-HFS)

Completed

• Conditions: Colorectal Cancer; Gastric Cancer (GC); Capecitabine; Hand Foot Syndrome

• Registration Number: NCT07177560
• Lead Sponsor: Gazi University

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 activities and lead to treatment modifications.

This prospective observational study is being conducted at two tertiary oncology centers in Turkey to evaluate whether prophylactic use of topical diclofenac gel can prevent or delay the development of HFS in patients receiving capecitabine for colorectal or gastric cancer. Approximately 150 patients are enrolled and managed according to physician preference. Patients either receive topical diclofenac gel (applied twice daily to the hands and feet) or are followed with active monitoring.

The primary objective is to assess the incidence of grade 2 or 3 HFS. Secondary objectives include time to onset of HFS and the frequency of capecitabine dose reductions related to HFS.

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) can negatively impact treatment adherence and quality of life by necessitating dose interruptions or reductions. The underlying mechanisms are not fully understood, but inflammatory pathways, including cyclooxygenase-2 (COX-2) signaling, are thought to contribute.

Preventive strategies for HFS remain limited. Celecoxib, a systemic COX-2 inhibitor, has been shown to reduce HFS incidence but is not widely adopted due to safety concerns. Topical diclofenac gel, a locally acting nonsteroidal anti-inflammatory drug (NSAID), represents a potential low-toxicity prophylactic approach.

This prospective, multicenter observational study is designed to evaluate the prophylactic effect of topical diclofenac in patients with colorectal or gastric cancer initiating capecitabine therapy. The study is conducted at Gazi University Faculty of Medicine and Ankara Etlik City Hospital. Eligible participants are adults scheduled to receive capecitabine-based therapy who have not received prior chemotherapy.

Participants are managed according to physician preference:

Topical diclofenac group: Patients apply 1% topical diclofenac gel to clean, dry skin on the hands and feet twice daily during capecitabine treatment.

Observation group: Patients are followed with active monitoring without prophylactic intervention.

The primary endpoint is the incidence of grade 2 or 3 HFS, assessed weekly using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary endpoints include time to onset of HFS and the proportion of patients requiring capecitabine dose reductions due to HFS.

The planned enrollment is approximately 150 patients, with follow-up continuing until either the onset of clinically significant HFS or completion of capecitabine therapy.

Study Timeline

• Study Start: 2023-07-30
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of grade ≥2 hand-foot syndrome (HFS)	Up to 24 weeks (from first capecitabine dose through study completion)	Proportion of participants who develop grade ≥2 HFS during capecitabine therapy. HFS will be assessed weekly by oncology clinicians using the Common Terminology Criteria for Adverse Events (CTCAE). Numerator: participants with grade ≥2 HFS; Denominator: all enrolled participants.

Secondary Outcome Measures

Name	Time	Method
Time to onset of grade ≥2 hand-foot syndrome (HFS)	Up to 24 weeks (baseline to first event or end of study follow-up)	Time (weeks) from the first capecitabine dose to the first documentation of grade ≥2 HFS per CTCAE. Participants without the event will be censored at end of treatment or end of follow-up.

Trial Locations

Locations (2)

Ankara Etlik City Hospital; Ankara, Turkey (Türkiye)

Gazi University; Ankara, Turkey (Türkiye)