StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients

Breast Carcinoma Clinical Trial

Official title:

A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05073172
• Other study ID #: STUDY00018789
• Secondary ID: NCI-2021-09431ST
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.

Description:

PRIMARY OBJECTIVE: I. Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance. SECONDARY OBJECTIVES: I. Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care. EXPLORATORY OBJECTIVES: I. To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance. III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. ARM II: Patients receive standard of care including calendula and/or petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor) applied 2-6 times daily plus hydrogel or silver sulfadiazine (Silvadene) or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1. After completion of study, patients are followed up at 6 days and 3 weeks post-RT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will be adult (> age of 18) patients. Both men and women and members of all races and ethnic groups will be included
• Histologically confirmed malignancy for which standard curative measures in conjunction with radiotherapy are indicated to the following sites: whole breast/chest-wall for post-surgical radiotherapy or bilateral neck (levels one through six) for head and neck cancer
• All head and neck cancer patients should have the left and right neck treated to the same dose when receiving bilateral neck irradiation
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Clinically evident skin involvement of malignancy
• Thin patients with nodal involvement requiring bolus
• Patients with significant unshaven facial or chest wall hair compromising film application
• Evidence of active cellulitis or wound infection involving anticipated treatment site
• History of prior radiotherapy to involved site within 5 cm of anticipated treatment field
• Eastern Cooperative Oncology Group (ECOG) performance status >= 3
• Patients receiving concurrent capecitabine
• Patient with skin grafts over treatment site(s)
• Presence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. (i.e. schizophrenia, autism, temporary housing during treatment, scheduling conflict immediately after treatment. This will need to be assessed prior to consent
• Actual or perceived inability to reliably apply StrataXRT to the patients treatment field in the home environment
• Anticipated or actual use of other non-study topical medications or remedies in the treatment field
• Vulnerable populations (pregnant women, decisionally impaired adults, and prisoners) will be excluded from the study
• Patients receiving ultra-hypofractionated radiation to the breast

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Dermatitis
• Head and Neck Carcinoma
• Radiation-Induced Dermatitis
• Radiodermatitis

Intervention

Drug:
• Calendula Ointment
Applied topically

Other:
• Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Applied topically
• Polyethylene Glycol Hydrogel
Applied topically

Drug:
• Silicone-based Film Forming Topical Gel
Applied topically
• Silver Sulfadiazine
Applied topically
• Topical Hydrocortisone
Applied topically

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weekly Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores		Up to week 3 post-RT
Other	Average cost of StrataXRT tubes		Until healed (grade =< 1 dermatitis), up to 10 weeks
Other	Incidence of use of skin care products in addition to StrataXRT		Until healed (grade =< 1 dermatitis), up to 10 weeks
Other	Overall RT duration		Up to Day 0 post-RT
Other	Number of days missed (attributable to patient or provider concern re: dermatologic toxicity)		Up to Day 0 post-RT
Primary	Radiation dermatitis	Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).	Day 0 post-radiation therapy (RT)
Secondary	Grade 2+ radiation dermatitis	Will be assessed by CTCAE version 5.0.	Day 0 post-RT
Secondary	Grade 2+ radiation dermatitis	Will be assessed by CTCAE version 5.0.	Day 6 +/- 1 post-RT
Secondary	Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores	Will continue to assess CTCAE score for radiation dermatitis until resolution of symptoms.	Up to week 3 post-RT
Secondary	Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score		Up to week 3 post-RT
Secondary	Post-RT recovery time (to grade =< 1 radiation dermatitis	Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).	Up until entire irradiated treatment site healed (grade =< 1 dermatitis)