RECRUITING

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)

Conditions

Radiation Dermatitis Breast Cancer post-mastectomy radiation therapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Radiotherapy is a mainstay of treatment in breast cancer treatment, in the adjuvant setting. Radiation dermatitis occurs in up to 65% of these patients; currently, there is no standard of care for this treatment-related toxicity. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream (termed "Dermaprazole") in patients who require radiation for breast cancer in the adjuvant setting.

Official Title

A Phase I/II Study of Dermaprazole for Radiation Dermatitis in Post-Mastectomy Breast Cancer Patients.

Quick Facts

Study Start:2023-04-24

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05269160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy 2. Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment) 3. Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED) 4. Age 18 years or older 5. Women of childbearing potential (any woman with menses in the last 12 months) must agree to pregnancy testing and contraceptive use throughout the study period. Testing consists of human chorionic gonadotropin (HCG) urine testing, which if suspected to be falsely positive may be confirmed by ultrasound. If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study. In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable. If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 7. Written Informed Consent 8. History and Physical within 12 weeks of enrollment	1. Prior chest wall radiotherapy 2. Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment 3. Concurrent chemotherapy 4. Biopsy-proven epidermal involvement or positive margins 5. Open wound at time of consultation, or delayed surgical wound healing as defined as open wound \>8 weeks post-op 6. Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis. 7. Allergy or sensitivity to proton pump inhibitors 8. Pregnancy or breast feeding 9. Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate

Inclusion Criteria

Exclusion Criteria

1. Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy
2. Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)
3. Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)
4. Age 18 years or older
5. Women of childbearing potential (any woman with menses in the last 12 months) must agree to pregnancy testing and contraceptive use throughout the study period. Testing consists of human chorionic gonadotropin (HCG) urine testing, which if suspected to be falsely positive may be confirmed by ultrasound. If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study. In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable. If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
7. Written Informed Consent
8. History and Physical within 12 weeks of enrollment

1. Prior chest wall radiotherapy
2. Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
3. Concurrent chemotherapy
4. Biopsy-proven epidermal involvement or positive margins
5. Open wound at time of consultation, or delayed surgical wound healing as defined as open wound \>8 weeks post-op
6. Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis.
7. Allergy or sensitivity to proton pump inhibitors
8. Pregnancy or breast feeding
9. Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate

Contacts and Locations

Study Contact

Michelle S Ludwig, MD, MPH, PhD

CONTACT

713-566-3757

Michelle.Ludwig@bcm.edu

Principal Investigator

Michelle S Ludwig, MD, MPH, PhD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine Medical Center - McNair Campus

Houston, Texas, 77030

United States

Baylor St. Luke's Medical Center

Houston, Texas, 77030

United States

Harris Health System - Smith Clinic

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Michelle S Ludwig

Michelle S Ludwig, MD, MPH, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-24

Study Completion Date2028-01

Study Record Updates

Study Start Date2023-04-24

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

Radiation dermatitis
post-mastectomy
radiation therapy
breast cancer

Additional Relevant MeSH Terms

Radiation Dermatitis
Breast Cancer