Simple gel may prevent chemo side effect
NCT ID NCT07177560
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at whether applying a topical diclofenac gel to the hands and feet could prevent or delay hand-foot syndrome in patients with colorectal or gastric cancer taking capecitabine. About 150 patients were observed at two cancer centers in Turkey. The goal was to see if the gel reduces the number of patients who develop moderate to severe skin reactions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- topical diclofenac gel
- What this could lead to
- If it works, this could offer a simple, low-cost way to prevent a painful side effect of chemotherapy, helping patients stay on treatment.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less reliable. The gel may not prevent hand-foot syndrome, and some patients may still need dose reductions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
151 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
-
Feb 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
-
Gazi University
Ankara, Turkey (Türkiye)
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