Clinical trial NCT05553392: 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
Overall status: TERMINATED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of acute >grade 2 radiation dermatitis
timeFrame: Until 8 weeks post radiation therapy; up to 4 months
Secondary outcomes:
measure: Average toxicity assessed using the CTCAE
timeFrame: Until 8 weeks post radiation therapy; up to 4 months
measure: Time to onset of moist desquamation
timeFrame: Until 8 weeks post radiation therapy; up to 4 months
measure: Pain scores
timeFrame: Until 8 weeks post radiation therapy; up to 4 months
measure: Itchiness score
timeFrame: Until 8 weeks post radiation therapy; up to 4 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
Study officials:
References: