StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

Not Applicable

Recruiting

• Conditions: Radiation Dermatitis

• Registration Number: NCT05553392
• Lead Sponsor: Stratpharma AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Study Start: 2022-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of acute >grade 2 radiation dermatitis	Until 8 weeks post radiation therapy; up to 4 months	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

Name	Time	Method
Itchiness score	Until 8 weeks post radiation therapy; up to 4 months	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.
Average toxicity assessed using the CTCAE	Until 8 weeks post radiation therapy; up to 4 months	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	Until 8 weeks post radiation therapy; up to 4 months	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	Until 8 weeks post radiation therapy; up to 4 months	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.