Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Capecitabine | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hand Foot Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Topical Diclofenac
- description
- 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).
- label
- Observation
- description
- 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).
Primary outcomes (1)
- measure
- Incidence of grade ≥2 hand-foot syndrome (HFS)
- timeFrame
- Up to 24 weeks (from first capecitabine dose through study completion)
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAkdogan O, Yucel SE, Yazici O, Yucel KB, Gurler F, Uyar GC, Savas G, Yesilbas E, Coskun U, Baskurt K, Uner A, Ozet A, Oksuzoglu B, Ozdemir N, Sutcuoglu O. Topical Diclofenac for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Prospective Real-World Study. JCO Glob Oncol. 2026 Aug;12(8):e2600151. doi: 10.1200/GO-26-00151. Epub 2026 Aug 20. PMID 42623594