NCT07177560Completed
Topical Diclofenac for Hand-Foot Syndrome Prevention in Colorectal and Gastric Cancer on Capecitabine (DICLO-HFS)
Prospective Observational Study Assessing the Prophylactic Effect of Topical Diclofenac on Hand-Foot Syndrome in Patients With Colorectal and Gastric Cancer Receiving Capecitabine
Source: ClinicalTrials.gov · Last updated 17 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 151 (actual)
- First submitted
- 9 Sept 2025
- Start date
- 30 Jul 2023
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- Gazi University
- NCT number
- NCT07177560
What you commit to
- Study type: Observational
- Participants enrolled: 151
- From 30 Jul 2023 to the primary completion date, 28 Feb 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or planned systemic NSAID use during capecitabine therapy.
Other illness
- Pre-existing dermatologic conditions affecting hands/feet (e.g., eczema, psoriasis) or peripheral neuropathy.
- Sjögren's syndrome involving hands or feet.
- Known hypersensitivity to diclofenac, aspirin, or other NSAIDs (e.g., history of asthma, urticaria, allergic reactions).
Other
- Use of other HFS prophylaxis at baseline (e.g., topical NSAIDs other than diclofenac, pyridoxine).
- Planned initial capecitabine dose \<2,000 mg/m²/day.
- Anticipated inability to comply with weekly follow-up assessments.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ankara Etlik City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gazi University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
Related publications
- Topical Diclofenac for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Prospective Real-World Study.JCO Glob Oncol · 2026 · PMID 42623594
This page is information, not medical advice. Discuss any trial with your doctor.