Overview

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

Status:
Not yet recruiting

Trial end date:
2027-01-01

Target enrollment:
0

Participant gender:
All

Summary

Radiotherapy is a mainstay of treatment in head and neck cancer and breast cancer treatment, typically following surgery and/or chemotherapy. Radiation dermatitis, which involves redness, dryness, and/or peeling of the skin, occurs in up to 95% of patients receiving radiation therapy. There is currently no standard therapy for this treatment-related adverse effect. 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 either breast cancer in the postmastectomy setting or head and neck cancer in the definitive or adjuvant setting.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Michelle S Ludwig

Criteria

Inclusion Criteria:

Arm B: Breast cancer arm

1. Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR
ii) Modified radical mastectomy, OR iii)Radical 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. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

6. Written Informed Consent

7. History and Physical within 12 weeks of enrollment

Arm A: Head & Neck cancer arm

1. Patients with squamous cell carcinoma of the head and neck confirmed with
institutional pathology (diagnosed within 2 years of enrollment)

2. Planned to receive concurrent chemoradiation with any radiosensitizing regimen (such
as cisplatin) of at least 60 Gy or higher (note: chemotherapy per medical oncology and
otolaryngology).

3. Age 18 years or older

4. ECOG performance status 0 to 2

5. Written Informed Consent

6. History and Physical within 12 weeks of enrollment

Exclusion Criteria:

Arm B: Breast Cancer arm

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

Arm A: Head & Neck cancer arm

1. Prior head and neck 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. Lack of concurrent chemotherapy

4. Open wound at time of simulation

5. Known active collagen vascular diseases such as systemic lupus erythematous,
scleroderma or dermatomyositis.

6. Allergy or sensitivity to proton pump inhibitors

7. Pregnancy or breast feeding

8. Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate