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

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ClinicalTrials.gov Identifier: NCT05641246
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : January 30, 2023
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
German University in Cairo

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.

Condition or disease Intervention/treatment Phase
Hand and Foot Syndrome Drug: (CARBAMIDE®) Drug: (VOLTAREN®) Emulgel 1% Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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)
Masking: Single (Participant)
Masking Description: The Principle investigator and the Researcher are aware of the intervention taken for each participant. The participant will be blinded ( Single blinded)
Primary Purpose: Prevention
Official Title: Effect of Topical Diclofenac on Clinical Outcome in Breast Cancer Patients Treated With Capecitabine: A Randomized Controlled Trial.
Actual Study Start Date : December 8, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: Control Arm
  • 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®)
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.
Other Name: Urea-based cream

Active Comparator: Intervention Arm
  • 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®)
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.
Other Name: Urea-based cream

Drug: (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.
Other Name: Diclofenac Sodium




Primary Outcome Measures :
  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). [ Time Frame: One year ]
    • 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study is conducted on Breast Cancer patients which the majority are females and Males with Breast Cancer are considered rare
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641246


Contacts
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Contact: Samaa EL-bastawisy, Bachelor of pharmacy 0201210343732 sama.ahmed199719@gmail.com
Contact: Loay Kassem, Asst.prof of Clinical oncology 0201003022907 Loay.Kassem@Cairocure.com

Locations
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Egypt
KASR ALAINY Center of Oncology and Nuclear medicine Recruiting
Cairo, Egypt
Contact: Loay Kassem, Assistant professor    01003022907    Loay.kassem@Cairocure.com   
Principal Investigator: Loay Kassem, Assistant professor         
Sponsors and Collaborators
German University in Cairo
Cairo University
Publications:
Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, Abraham M, Medeiros Alencar VH, Badran A, Bonfill X, Bradbury J, Clarke M, Collins R, Davis SR, Delmestri A, Forbes JF, Haddad P, Hou MF, Inbar M, Khaled H, Kielanowska J, Kwan WH, Mathew BS, Mittra I, Muller B, Nicolucci A, Peralta O, Pernas F, Petruzelka L, Pienkowski T, Radhika R, Rajan B, Rubach MT, Tort S, Urrutia G, Valentini M, Wang Y, Peto R; Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013 Mar 9;381(9869):805-16. doi: 10.1016/S0140-6736(12)61963-1. Erratum In: Lancet. 2013 Mar 9;381(9869):804. Lancet. 2017 May 13;389(10082):1884.

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Responsible Party: German University in Cairo
ClinicalTrials.gov Identifier: NCT05641246    
Other Study ID Numbers: CPH-2022-10-MHS-2
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by German University in Cairo:
Capecitabine
Breast Cancer
Hand and Foot Syndrome
Diclofenac Sodium
Additional relevant MeSH terms:
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Hand-Foot Syndrome
Skin Diseases
Drug Eruptions
Dermatitis
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action