StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

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 leftinguinal regions

• Patients will receive elective radiation therapy to bilateral inguinal nodal regionsprescribed 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 skinassessment 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 theduration of study participation. Abstinence is acceptable if preferred by patient.Should a woman become pregnant or suspect she is pregnant while participating inthis 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 itadministered to them as required by this study.

• Patients with any medical condition such as active connective tissue disorder thatpredisposes 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 onthis study.

• Female patients who are pregnant or breast feeding.

• Patients who are unable to give written informed consent, or are unable to havewritten consent given on their behalf.