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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Carcinoma; Head and Neck Carcinoma; Radiation-Induced Dermatitis
• Intervention / Treatment: Drug: Silicone-based Film Forming Topical Gel; Drug: Calendula Ointment; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Polyethylene Glycol Hydrogel; Drug: Silver Sulfadiazine; Drug: Topical Hydrocortisone

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: SSD; Flamazine; Silvadene; Sliverex; Sulfadiazine Silver; Thermazene; Drug: Topical Hydrocortisone; Applied topically

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dermatitis	Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).	Day 0 post-radiation therapy (RT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 2+ radiation dermatitis	Will be assessed by CTCAE version 5.0.	Day 0 post-RT
Grade 2+ radiation dermatitis	Will be assessed by CTCAE version 5.0.	Day 6 +/- 1 post-RT
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
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	Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).	Up until entire irradiated treatment site healed (grade =< 1 dermatitis)

Other Outcome Measures

Outcome Measure	Time Frame
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	Up to Day 0 post-RT
Number of days missed (attributable to patient or provider concern re: dermatologic toxicity)	Up to Day 0 post-RT

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Josh Walker, M.D., Ph.D., OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Wounds and Injuries; Breast Diseases; Radiation Injuries; Breast Neoplasms; Carcinoma; Dermatitis; Radiodermatitis; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Emollients; Coccidiostats; Hydrocortisone; Petrolatum; Mineral Oil; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: STUDY00018789 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-09431 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes