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Simple gel may prevent chemo side effect

NCT ID NCT07177560

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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