CompletedPhase 2

Effect of Topical Diclofenac on Clinical Outcome in Breast Cancer Patients Treated With Capecitabine

Egypt86 participantsStarted 2022-12-08

Plain-language summary

The aim of the study is to evaluate the efficacy of using combination of Urea-based cream (CARBAMIDE®) and topical diclofenac (VOLTAREN®) Emulgel 1% for improving the incidence of Hand-foot syndrome in histologically proven breast cancer Egyptian patients receiving single agent chemotherapy Capecitabine (XELODA ®) and Its effect on improving patients' quality of life.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

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Inclusion criteria

✓. Adults aged 18 years and above.
✓. Females.
✓. Histologically proven breast cancer patients receiving Capecitabine (XELODA ®) chemotherapy.
✓. life expectancy greater than 18 weeks.

Exclusion criteria

✕. Hypersensitivity to diclofenac, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS).
✕. History of Urticaria.
✕. History of acute rhinitis
✕. Asthmatic Patients.

What they're measuring

• Incidence of HFS between control arm (Urea-based cream (CARBAMIDE®)) and intervention arm (Combination of Urea-based cream (CARBAMIDE®) and (VOLTAREN®) Emulgel 1%) measured by (CTCAE v 5.0).

Timeframe: One year

Trial details

NCT IDNCT05641246

SponsorGerman University in Cairo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-15

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