StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

Stratpharma

Status: Terminated

Conditions: Radiation Dermatitis

Treatments: Drug: Aquaphor; Device: StrataXRT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05553392

SPASX018

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

StrataXRT

Experimental group

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.

Treatment:

Device: StrataXRT

Aquaphor

Active Comparator group

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.

Treatment:

Drug: Aquaphor