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

NCT ID: NCT05073172

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-07-01

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.

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.

Conditions

Breast Carcinoma; Head and Neck Carcinoma; Radiation-Induced Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Silicone-based Film Forming Topical Gel

Intervention Type: DRUG

Applied topically

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.

Group Type: ACTIVE_COMPARATOR

Calendula Ointment

Intervention Type: DRUG

Applied topically

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Intervention Type: OTHER

Applied topically

Polyethylene Glycol Hydrogel

Intervention Type: OTHER

Applied topically

Silver Sulfadiazine

Intervention Type: DRUG

Applied topically

Topical Hydrocortisone

Intervention Type: DRUG

Applied topically

Interventions

Calendula Ointment

Applied topically

Intervention Type: DRUG

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Applied topically

Intervention Type: OTHER

Polyethylene Glycol Hydrogel

Applied topically

Intervention Type: OTHER

Silicone-based Film Forming Topical Gel

Applied topically

Intervention Type: DRUG

Silver Sulfadiazine

Applied topically

Intervention Type: DRUG

Topical Hydrocortisone

Applied topically

Intervention Type: DRUG

Other Intervention Names

Aquaphor; PEG Hydrogel; Silicone-based Film-forming Gel Dressing; StrataCTX; StrataXRT; StrataXRT Gel; Flamazine; Silvadene; Sliverex; SSD; Sulfadiazine Silver; Thermazene

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Josh Walker, M.D., Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh Walker, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCI-2021-09431

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00018789

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00018789

Identifier Type: -

Identifier Source: org_study_id