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

NCT05641246 | Completed Phase 2

• 1 other identifier: CPH-2022-10-MHS-2
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand and Foot Syndrome

Keywords

Capecitabine; Breast Cancer; Hand and Foot Syndrome; Diclofenac Sodium

Outcome Measures

Primary Outcomes (1)

• • 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).

  • 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 (Common Terminology Criteria for Adverse Effects CTCAE v 5.0).

  One year

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

* Standard of care Urea-based cream (CARBAMIDE®) will be applied to hands and feet 2-3 times daily for 14 days starting from the first dose and cycle of Capecitabine (XELODA ®). * Each Capecitabine (XELODA ®) cycle lasts for 21 days. * Capecitabine (XELODA ®) dose :2g/m2 daily divided into 2 doses after breakfast and dinner for 14 days followed by 7 days Capecitabine free. * Capecitabine (XELODA ®) dose will be modified according to treatment related side effects (26). * This regimen will be repeated at each cycle of Capecitabine (XELODA ®) and lasts for 6 cycles (18 weeks) and preventive measures of Hand-foot syndrome will be applied (Avoid mechanical stress

Drug: (CARBAMIDE®)

Intervention Arm

ACTIVE COMPARATOR

* Standard of care Urea-based cream (CARBAMIDE®) will be applied to hands and feet twice daily for 14 days starting from the first dose and cycle of Capecitabine (XELODA ®). * Each Capecitabine (XELODA ®) cycle lasts for 21 days. * Capecitabine (XELODA ®) dose: 2g/m2 daily divided into 2 doses after breakfast and dinner for 14 days followed by 7 days Capecitabine free. * Capecitabine (XELODA ®) dose will be modified according to treatment related side effects (26). * This regimen will be repeated at each cycle of Capecitabine (XELODA ®) and lasts for 6 cycles (18 weeks) and preventive measures of Hand-foot syndrome will be applied (Avoid mechanical stress Plus * Topical diclofenac (VOLTAREN®) Emulgel 1% 2-4g (2g = 4 fingertip Units (FTU)) twice daily 2 hours away from Urea-based cream (CARBAMIDE®) for 14 days starting from the first cycle and dose of Capecitabine. * This regimen will be repeated at each cycle of Capecitabine (XELODA ®) and lasts for 6 cycles (18 weeks).

Drug: (CARBAMIDE®); Drug: (VOLTAREN®) Emulgel 1%

Interventions

(CARBAMIDE®) DRUG

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.

Also known as: Urea-based cream

Control Arm; Intervention Arm

(VOLTAREN®) Emulgel 1% DRUG

(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.

Also known as: Diclofenac Sodium

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Study is conducted on Breast Cancer patients which the majority are females and Males with Breast Cancer are considered rare
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• German University in Cairo: lead
• Cairo University: collaborator

Study Sites (1)

KASR ALAINY Center of Oncology and Nuclear medicine

Cairo, Egypt

Location

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MeSH Terms

Conditions

Hand-Foot Syndrome; Breast Neoplasms

Interventions

Urea; Diclofenac

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The Principle investigator and the Researcher are aware of the intervention taken for each participant. The participant will be blinded ( Single blinded)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 7, 2022
• Study Start: December 8, 2022
• Primary Completion: November 15, 2023
• Study Completion: December 8, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)