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

Sponsor

OHSU Knight Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05073172

Collaborator

Oregon Health and Science University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma Head and Neck Carcinoma Radiation-Induced Dermatitis	Drug: Calendula Ointment Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment Other: Polyethylene Glycol Hydrogel Drug: Silicone-based Film Forming Topical Gel Drug: Silver Sulfadiazine	N/A

Detailed Description

PRIMARY OBJECTIVE:

Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance.

SECONDARY OBJECTIVES:

Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care.

EXPLORATORY OBJECTIVES:

To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (StrataXRT) 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.	Drug: Silicone-based Film Forming Topical Gel Applied topically Other Names: Silicone-based Film-forming Gel Dressing StrataCTX StrataXRT StrataXRT Gel
Active Comparator: Arm II (standard of care) Patients receive standard of care including calendula and/or Aquaphor applied 2-6 times daily plus hydrogel or Silvadene or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1.	Drug: Calendula Ointment Applied topically Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment Applied topically Other Names: Aquaphor Other: Polyethylene Glycol Hydrogel Applied topically Other Names: PEG Hydrogel Drug: Silver Sulfadiazine Applied topically Other Names: Flamazine Silvadene Sliverex SSD Sulfadiazine Silver Thermazene

Arm

Intervention/Treatment

Experimental: Arm I (StrataXRT)

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.

Drug: Silicone-based Film Forming Topical Gel

Applied topically

Other Names:

Silicone-based Film-forming Gel Dressing

StrataCTX

StrataXRT

StrataXRT Gel

Active Comparator: Arm II (standard of care)

Patients receive standard of care including calendula and/or Aquaphor applied 2-6 times daily plus hydrogel or Silvadene or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =< 1.

Drug: Calendula Ointment

Applied topically

Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Applied topically

Other Names:

Aquaphor

Other: Polyethylene Glycol Hydrogel

Applied topically

Other Names:

PEG Hydrogel

Drug: Silver Sulfadiazine

Applied topically

Other Names:

Flamazine

Silvadene

Sliverex

SSD

Sulfadiazine Silver

Thermazene

Outcome Measures

Primary Outcome Measures

Radiation dermatitis [Day 0 post-radiation therapy (RT)]
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).

Secondary Outcome Measures

Grade 2+ radiation dermatitis [Day 0 post-RT]
Will be assessed by CTCAE version 5.0.
Grade 2+ radiation dermatitis [Day 6 +/- 1 post-RT]
Will be assessed by CTCAE version 5.0.
Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores [Up to week 3 post-RT]
Will continue to assess CTCAE score for radiation dermatitis until resolution of symptoms.
Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score [Up to week 3 post-RT]
Post-RT recovery time (to grade =< 1 radiation dermatitis [Up till entire irradiated treatment site healed (grade =< 1 dermatitis)]
Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).

Other Outcome Measures

Weekly Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores [Up to week 3 post-RT]
Average cost of StrataXRT tubes [Until healed (grade =< 1 dermatitis), up to 10 weeks]
Incidence of use of skin care products in addition to StrataXRT [Until healed (grade =< 1 dermatitis), up to 10 weeks]
Overall RT duration [Day 0 post-RT]
Number of days missed (attributable to patient or provider concern re: dermatologic toxicity) [Day 0 post-RT]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 facialor 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