search
Back to results

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

Primary Purpose

Radiation Dermatitis, Breast Cancer, Head and Neck Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dermaprazole 1%
Dermaprazole 2%
Sponsored by
Michelle S Ludwig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Radiation Dermatitis focused on measuring Radiation dermatitis, post-mastectomy, radiation therapy, breast cancer, head and neck cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of Medicine Medical Center - McNair CampusRecruiting
  • Baylor St. Luke's Medical CenterRecruiting
  • Harris Health System - Smith ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dermaprazole 1% (Arm A:Head and neck)

Dermaprazole 1% (ArmB: Breast)

Dermaprazole 2% (Arm A: Head and neck)

Dermaprazole 2% (Arm B: Breast)

Arm Description

Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Outcomes

Primary Outcome Measures

Number of participants with Dose-Limiting Toxicity(DLT) in phase I
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.
Rate of clinically bothersome radiation dermatitis at maximum feasible dose in phase II
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

Rate of grade 2 or higher acute radiation dermatitis
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.
Median- occurrence time of grade 2 or higher acute radiation dermatitis
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.
Median-healing time of grade 2 or higher acute radiation dermatitis develops
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.
Median of the peak score of each QOL component
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).
Number of missed treatments due to skin toxicity
The missing numbers of treatment due to skin toxicity will be counted.

Full Information

First Posted
February 25, 2022
Last Updated
May 4, 2023
Sponsor
Michelle S Ludwig
search

1. Study Identification

Unique Protocol Identification Number
NCT05269160
Brief Title
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ)
Official Title
A Phase I/II Study of Dermaprazole For Radiation Dermatitis in Post-Mastectomy Breast Cancer and Head and Neck Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle S Ludwig

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis, Breast Cancer, Head and Neck Cancer
Keywords
Radiation dermatitis, post-mastectomy, radiation therapy, breast cancer, head and neck cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dermaprazole 1% (Arm A:Head and neck)
Arm Type
Experimental
Arm Description
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Arm Title
Dermaprazole 1% (ArmB: Breast)
Arm Type
Experimental
Arm Description
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Arm Title
Dermaprazole 2% (Arm A: Head and neck)
Arm Type
Experimental
Arm Description
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Arm Title
Dermaprazole 2% (Arm B: Breast)
Arm Type
Experimental
Arm Description
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Intervention Type
Drug
Intervention Name(s)
Dermaprazole 1%
Intervention Description
Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
Intervention Type
Drug
Intervention Name(s)
Dermaprazole 2%
Intervention Description
Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks
Primary Outcome Measure Information:
Title
Number of participants with Dose-Limiting Toxicity(DLT) in phase I
Description
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.
Time Frame
from the first day applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment
Title
Rate of clinically bothersome radiation dermatitis at maximum feasible dose in phase II
Description
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.
Time Frame
at weekly during radiation treatment, up to 7 weeks
Secondary Outcome Measure Information:
Title
Rate of grade 2 or higher acute radiation dermatitis
Description
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.
Time Frame
from the first day the subject applies the cream to the end of the 6 month follow up period
Title
Median- occurrence time of grade 2 or higher acute radiation dermatitis
Description
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.
Time Frame
from the first day the subject applies the cream to the end of the 6 month follow up period
Title
Median-healing time of grade 2 or higher acute radiation dermatitis develops
Description
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.
Time Frame
from the first day the subject applies the cream to the end of the 6 month follow up period
Title
Median of the peak score of each QOL component
Description
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).
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
Title
Number of missed treatments due to skin toxicity
Description
The missing numbers of treatment due to skin toxicity will be counted.
Time Frame
at weekly during radiation treatment, up to 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Arm B: Breast cancer arm Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment) Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED) Age 18 years or older Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Written Informed Consent History and Physical within 12 weeks of enrollment Arm A: Head & Neck cancer arm Patients with squamous cell carcinoma of the head and neck confirmed with institutional pathology (diagnosed within 2 years of enrollment) 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). Age 18 years or older ECOG performance status 0 to 2 Written Informed Consent History and Physical within 12 weeks of enrollment Exclusion Criteria: Arm B: Breast Cancer arm Prior chest wall radiotherapy 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 Concurrent chemotherapy Biopsy-proven epidermal involvement or positive margins Open wound at time of consultation, or delayed surgical wound healing as defined as open wound >8 weeks post-op Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis. Allergy or sensitivity to proton pump inhibitors Pregnancy or breast feeding Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate Arm A: Head & Neck cancer arm Prior head and neck radiotherapy 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 Lack of concurrent chemotherapy Open wound at time of simulation Known active collagen vascular diseases such as systemic lupus erythematous, scleroderma or dermatomyositis. Allergy or sensitivity to proton pump inhibitors Pregnancy or breast feeding Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle S Ludwig, MD, MPH, PhD
Phone
713-566-3757
Email
Michelle.Ludwig@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle S Ludwig, MD, MPH, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine Medical Center - McNair Campus
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle S Ludwig, MD, MPH, PhD
Phone
713-566-3757
Email
Michelle.Ludwig@bcm.edu
Facility Name
Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle S Ludwig, MD, MPH, PhD
Phone
713-566-3757
Email
Michelle.Ludwig@bcm.edu
Facility Name
Harris Health System - Smith Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle S Ludwig, MD, MPH, PhD
Phone
713-566-3757
Email
Michelle.Ludwig@bcm.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs