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

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ClinicalTrials.gov Identifier: NCT05269160
Recruitment Status : Recruiting
First Posted : March 7, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Michelle S Ludwig, Baylor College of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Radiation Dermatitis Breast Cancer Head and Neck Cancer Drug: Dermaprazole 1% Drug: Dermaprazole 2% Phase 1 Phase 2

Detailed Description:

For this study, patients will be stratified into one of the following two arms: 1) head and neck or 2) breast cancer. All study participants will begin using Dermaprazole for 1-2 weeks prior to receiving radiation. During the CT Simulation, study participants will be instructed to apply Dermaprazole in a "patch test" area - an area of the chest outside of the field of radiation. This is to assess for immediate skin reactions including itching, irritation and allergy. If there are no immediate allergic reactions at the conclusion of the simulation visit, the study participant will be instructed to apply the cream in the area that will be irradiated in addition to the patch test area for 1-2 weeks until the radiation starts. During this period, if the patient is found to have no adverse events, they will then continue daily application both in the patch test area and in the radiation field during radiotherapy, and for 2 weeks after they complete their radiation treatment. During the entire time while using the Dermaprazole, study participants will be evaluated for adverse events such as contact dermatitis in the patch test area as well as radiation dermatitis within the treatment field. All participants will be followed for 6 months after the final Dermaprazole application.

Two dose levels of Dermaprazole (1% and 2%) will be evaluated in the combination Phase I/II dose escalation/de-escalation BOIN design study evaluating preliminary efficacy at the Maximum Feasible Dose (MFD). The Dermaprazole will be initiated at a dose of 1% and escalated to 2% as appropriate based on the number of adverse events. A Dose Limiting Toxicity (DLT) will be defined as any of the following: a) any > Grade 2 skin toxicity outside the radiation field (Macules/ papules covering 10-30% of the area with or without symptoms of pruritus, burning, tightness), b) any > Grade 2 radiation dermatitis (Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema) inside the radiation field that is probably or definitely related to Dermaprazole (AE attribution will be at the discretion of the study PI/Co-I). c) Any > Grade 4 radiation dermatitis inside the radiation field. A DLT will be detected from the first day the subject starts applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment. Dermatitis will be evaluated by a radiation oncologist on a weekly basis using the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria, and all radiation dermatitis scores will be independently verified by a dermatologist who will evaluate the photographs at the end of treatment. Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase I/II Study of Dermaprazole For Radiation Dermatitis in Post-Mastectomy Breast Cancer and Head and Neck Cancer Patients.
Actual Study Start Date : April 24, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dermaprazole 1% (Arm A:Head and neck)
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
 Drug: Dermaprazole 1%
Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
Experimental: Dermaprazole 1% (ArmB: Breast)
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
 Drug: Dermaprazole 1%
Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
Experimental: Dermaprazole 2% (Arm A: Head and neck)
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
 Drug: Dermaprazole 2%
Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks
Experimental: Dermaprazole 2% (Arm B: Breast)
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
 Drug: Dermaprazole 2%
Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Dose-Limiting Toxicity(DLT) in phase I [ Time Frame: from the first day applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment ]
    A DLT is defined as any of the following:1) Any > Grade 2 skin toxicity outside the radiation field for patients in both the H&N and BC groups;2). Any > Grade 2 radiation dermatitis inside the radiation field that is probably or definitely related to Dermaprazole for patients in both the H&N and BC groups. (AE Attribution will be at the discretion of the study PI/Co-I);3) 3. Any Grade > 4 radiation dermatitis inside the radiation field for any patients in both the H&N and BC groups. Any skin reaction ≥Grade 2 will lead to immediate halting of Dermaprazole use in that patient and reported as an adverse event and a dose limiting toxicity.

  2. Rate of clinically bothersome radiation dermatitis at maximum feasible dose in phase II [ Time Frame: at weekly during radiation treatment, up to 7 weeks ]

    The rate of radiation dermatitis is defined as the number of participants with radiation dermatitis divided by the total number of participants in each arm.

    Radiation dermatitis will be determined by the radiation oncologist and defined using NCI Common Terminology Criteria for Adverse Events (CTCAE version 5) for dermatitis radiation. In particular, the individual components of radiation dermatitis will be recorded: erythema, desquamation, edema, bleeding, skin necrosis and skin ulceration. This evaluation will be conducted in Arm A (head and neck) and Arm B (breast) separately.



Secondary Outcome Measures :
  1. Rate of grade 2 or higher acute radiation dermatitis [ Time Frame: from the first day the subject applies the cream to the end of the 6 month follow up period ]
    The proportion of patients with maximum observed acute grade 2, 3, and 4 skin reactions will be expressed in percentage. In particular, the individual components of radiation dermatitis will be recorded: erythema, desquamation, edema, bleeding, skin necrosis and skin ulceration.

  2. Median- occurrence time of grade 2 or higher acute radiation dermatitis [ Time Frame: from the first day the subject applies the cream to the end of the 6 month follow up period ]
    Median-occurrence of grade 2 or higher acute radiation dermatitis time on the Kaplan-Meier method is defined as the time between the first time of applying the cream and the time of occurrence of grade 2 or higher acute radiation dermatitis.

  3. Median-healing time of grade 2 or higher acute radiation dermatitis develops [ Time Frame: from the first day the subject applies the cream to the end of the 6 month follow up period ]
    Median-healing time of grade 2 or higher acute radiation dermatitis developing time on the Kaplan-Meier method is defined from time to develop the grade 2 or higher acute radiation dermatitis after applying the cream to healing the event.

  4. Median of the peak score of each QOL component [ Time Frame: at before and after Dermaprazole cream application at the CT simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy ]
    Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16 questionnaire for QOL. The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered).

  5. Number of missed treatments due to skin toxicity [ Time Frame: at weekly during radiation treatment, up to 7 weeks ]
    The missing numbers of treatment due to skin toxicity will be counted.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT05269160


Contacts
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Contact: Michelle S Ludwig, MD, MPH, PhD 713-566-3757 Michelle.Ludwig@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Medical Center - McNair Campus Recruiting
Houston, Texas, United States, 77030
Contact: Michelle S Ludwig, MD, MPH, PhD    713-566-3757    Michelle.Ludwig@bcm.edu   
Baylor St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Michelle S Ludwig, MD, MPH, PhD    713-566-3757    Michelle.Ludwig@bcm.edu   
Harris Health System - Smith Clinic Recruiting
Houston, Texas, United States, 77054
Contact: Michelle S Ludwig, MD, MPH, PhD    713-566-3757    Michelle.Ludwig@bcm.edu   
Sponsors and Collaborators
Michelle S Ludwig
Investigators
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Principal Investigator: Michelle S Ludwig, MD, MPH, PhD Baylor College of Medicine
More Information
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Responsible Party: Michelle S Ludwig, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05269160    
Other Study ID Numbers: H-45698
First Posted: March 7, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle S Ludwig, Baylor College of Medicine:
Radiation dermatitis
post-mastectomy
radiation therapy
breast cancer
head and neck cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Head and Neck Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries