Clinical trial

Effect of Topical Diclofenac on Clinical Outcome in Breast Cancer Patients Treated With Capecitabine: A Randomized Controlled Trial.

Name

CPH-2022-10-MHS-2

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.

Trial arms

Trial start

2022-12-08

Estimated PCD

2023-11-15

Trial end

2023-12-08

Status

Completed

Phase

Early phase I

Treatment

(CARBAMIDE®)

Urea is used to treat dry/rough skin conditions (such as eczema, psoriasis, corns, callus) and some nail problems (such as ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.

Arms:

Control Arm, Intervention Arm

Other names:

Urea-based cream

(VOLTAREN®) Emulgel 1%

(VOLTAREN®) Emulgel 1% contain the active ingredient diclofenac which belongs to the NSAIDS.it has analgesic and anti-inflammatory properties and due to its alcohol base it has a cooling effect.

Arms:

Intervention Arm

Other names:

Diclofenac Sodium

Size

Primary endpoint

• 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).

One year

Eligibility criteria

Inclusion Criteria: 1. Adults aged 18 years and above. 2. Females. 3. Histologically proven breast cancer patients receiving Capecitabine (XELODA ®) chemotherapy. 4. life expectancy greater than 18 weeks. Exclusion Criteria: 1. Hypersensitivity to diclofenac, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS). 2. History of Urticaria. 3. History of acute rhinitis 4. Asthmatic Patients.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study consists of 2 Arms, A control arm which will only receive standard of care (CARBAMIDE) and an intervention arm which will receive (CARBAMIDE and VOLTAREN)', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The Principle investigator and the Researcher are aware of the intervention taken for each participant. The participant will be blinded ( Single blinded)', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 86, 'type': 'ACTUAL'}}

Updated at

2024-01-03

1 organization

2 products

1 indication

Organization

German University in Cairo

Product

(CARBAMIDE®)

Indication

Hand-Foot Syndrome

Product

Voltaren Emulgel 1%