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

NCT07177560 | Completed

• 2 other identifiers: AESH-EKI-00220022
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Gastric Cancer (GC); Capecitabine; Hand Foot Syndrome

Keywords

Hand-Foot Syndrome; Capecitabine; Topical Diclofenac; Chemotherapy Toxicity; Supportive Care

Outcome Measures

Primary Outcomes (1)

• Incidence of grade ≥2 hand-foot syndrome (HFS)

  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.

  Up to 24 weeks (from first capecitabine dose through study completion)

Secondary Outcomes (1)

• Time to onset of grade ≥2 hand-foot syndrome (HFS)

  Up to 24 weeks (baseline to first event or end of study follow-up)

Other Outcomes (1)

• Treatment-emergent non-HFS adverse events (AEs)

  Up to 24 weeks (from first capecitabine dose through study completion)

Study Arms (2)

Topical Diclofenac

Patients with colorectal or gastric cancer receiving capecitabine who applied 1% topical diclofenac gel to the hands and feet twice daily throughout treatment. This group was managed according to physician preference and assessed weekly for the development of hand-foot syndrome (HFS).

Observation

Patients with colorectal or gastric cancer receiving capecitabine who were actively monitored without prophylactic topical treatment. These patients were assessed weekly for the development of hand-foot syndrome (HFS).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with histologically confirmed colorectal (colon or rectal) or gastric cancer who were initiating capecitabine-based therapy at two tertiary oncology centers in Ankara, Turkey (Gazi University; Ankara Etlik City Hospital). Patients were enrolled consecutively at treatment start and managed per treating physician practice into two observational cohorts: prophylactic 1% topical diclofenac gel vs active monitoring without prophylaxis. No prior systemic chemotherapy; weekly clinic assessments during therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Nuriye Ozdemir, MD

  Gazi University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Medical Oncology, Gazi University Faculty of Medicine

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: July 30, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

TU (2)