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NCT05641246

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

Completed Phase 2 Last updated 3 January 2024
What this trial tests

Phase 2 trial testing (CARBAMIDE®) in Hand and Foot Syndrome in 86 participants. Completed in 8 December 2023.

Timeline
8 December 2022
Primary endpoint
15 November 2023
8 December 2023

Quick facts

Lead sponsorGerman University in Cairo
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment86
Start date8 December 2022
Primary completion15 November 2023
Estimated completion8 December 2023
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

German University in Cairo

Who can join

Adults 18 to 80, female only, with Hand and Foot Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nanoemulgel: A Novel Nano Carrier as a Tool for Topical Drug Delivery.
    Donthi MR, Donthi MR, Munnangi SR, Krishna KV, et al · · 2023 · cited 73× · PMID 36678794 · DOI 10.3390/pharmaceutics15010164
  2. Lactate at the crossroads of tumor metabolism and immune escape: a new frontier in cancer therapy.
    Dong Z, Yuan Z, Jin T, Gao C, et al · · 2025 · cited 6× · PMID 41204256 · DOI 10.1186/s12967-025-07272-x

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Other German University in Cairo trials

Trials by the same sponsor.

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