Back to resultsStrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis
Primary Purpose
Radiation Dermatitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
StrataXRT
Aquaphor
Sponsored by
About this trial
This is an interventional prevention trial for Radiation Dermatitis
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 6 months
- Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
- Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
- No known allergy to studied products
- Able to give written informed consent, or have written consent given on their behalf
- Patients who are able and willing to attend the post-radiation weekly skin assessment appointments
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if preferred by patient. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Exclusion Criteria:
- Patients with gross cancer involvement of either or both inguinal regions.
- Patients who have received prior pelvic and/or inguinal radiation therapy.
- Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
- Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
- Patients with existing rashes or wounds in either inguinal region at baseline.
- Planned inguinal dissection within 90 days after completion of radiation therapy on this study.
- Female patients who are pregnant or breast feeding.
- Patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.
Sites / Locations
- Miami Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
StrataXRT
Aquaphor
Arm Description
Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides.
Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy.
Outcomes
Primary Outcome Measures
Incidence of acute >grade 2 radiation dermatitis
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions.
The amount of > grade 2 RD cases will be compared in both study groups.
Secondary Outcome Measures
Average toxicity assessed using the CTCAE
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD. Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The repeated measurements average toxicity will be compared in both study groups.
Time to onset of moist desquamation
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD.Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The time to moist desquamation will be compared in both study groups.
Pain scores
The participant will be asked to rate their pain level at the irradiated area. The time of interest of the original VAS is modified from "the past 24 hours" to "the past 7 days" for the specific purpose of this study. The VAS has been selected as it is a brief and easy tool for the assessment of pain within both the clinical and research settings. It has been well validated in both the chronic pain and cancer settings. The scale of 0 to 10 is simple for patients to use and reflects common clinical assessment of pain.
Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Itchiness score
Itching will be scored on a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine). Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05553392
Brief Title
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis
Official Title
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratpharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
StrataXRT
Arm Type
Experimental
Arm Description
Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides.
Arm Title
Aquaphor
Arm Type
Active Comparator
Arm Description
Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy.
Intervention Type
Device
Intervention Name(s)
StrataXRT
Intervention Description
StrataXRT is a full contact flexible wound dressing for the prevention and treatment of radiation dermatitis. StrataXRT is a semi-occlusive, self-drying and transparent gel.
When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns.
Intervention Type
Drug
Intervention Name(s)
Aquaphor
Intervention Description
Aquaphor is a brand of over-the-counter (OTC) skin care ointments manufactured by Beiersdorf Inc.
Aquaphor contains 41 percent petrolatum (or petroleum jelly), the active ingredient, temporarily protects minor cuts, scrapes, and burns; protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather.
Primary Outcome Measure Information:
Title
Incidence of acute >grade 2 radiation dermatitis
Description
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions.
The amount of > grade 2 RD cases will be compared in both study groups.
Time Frame
Until 8 weeks post radiation therapy; up to 4 months
Secondary Outcome Measure Information:
Title
Average toxicity assessed using the CTCAE
Description
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD. Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The repeated measurements average toxicity will be compared in both study groups.
Time Frame
Until 8 weeks post radiation therapy; up to 4 months
Title
Time to onset of moist desquamation
Description
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD.Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The time to moist desquamation will be compared in both study groups.
Time Frame
Until 8 weeks post radiation therapy; up to 4 months
Title
Pain scores
Description
The participant will be asked to rate their pain level at the irradiated area. The time of interest of the original VAS is modified from "the past 24 hours" to "the past 7 days" for the specific purpose of this study. The VAS has been selected as it is a brief and easy tool for the assessment of pain within both the clinical and research settings. It has been well validated in both the chronic pain and cancer settings. The scale of 0 to 10 is simple for patients to use and reflects common clinical assessment of pain.
Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Time Frame
Until 8 weeks post radiation therapy; up to 4 months
Title
Itchiness score
Description
Itching will be scored on a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine). Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.
The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Time Frame
Until 8 weeks post radiation therapy; up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Life expectancy of at least 6 months
Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
No known allergy to studied products
Able to give written informed consent, or have written consent given on their behalf
Patients who are able and willing to attend the post-radiation weekly skin assessment appointments
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if preferred by patient. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Exclusion Criteria:
Patients with gross cancer involvement of either or both inguinal regions.
Patients who have received prior pelvic and/or inguinal radiation therapy.
Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
Patients with existing rashes or wounds in either inguinal region at baseline.
Planned inguinal dissection within 90 days after completion of radiation therapy on this study.
Female patients who are pregnant or breast feeding.
Patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.
Facility Information:
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Rojas
Phone
786-527-8543
Email
CarolinaRoj@baptisthealth.net
12. IPD Sharing Statement
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StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis
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