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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calendula Ointment
Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Polyethylene Glycol Hydrogel
Silicone-based Film Forming Topical Gel
Silver Sulfadiazine
Topical Hydrocortisone
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (StrataXRT)

Arm II (standard of care)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Radiation dermatitis
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).

Secondary Outcome Measures

Grade 2+ radiation dermatitis
Will be assessed by CTCAE version 5.0.
Grade 2+ radiation dermatitis
Will be assessed by CTCAE version 5.0.
Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores
Will continue to assess CTCAE score for radiation dermatitis until resolution of symptoms.
Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score
Post-RT recovery time (to grade =< 1 radiation dermatitis
Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).

Full Information

First Posted
September 16, 2021
Last Updated
August 17, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05073172
Brief Title
StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients
Official Title
A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Head and Neck Carcinoma, Radiation-Induced Dermatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (StrataXRT)
Arm Type
Experimental
Arm Description
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 Title
Arm II (standard of care)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calendula Ointment
Intervention Description
Applied topically
Intervention Type
Other
Intervention Name(s)
Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Other Intervention Name(s)
Aquaphor
Intervention Description
Applied topically
Intervention Type
Other
Intervention Name(s)
Polyethylene Glycol Hydrogel
Other Intervention Name(s)
PEG Hydrogel
Intervention Description
Applied topically
Intervention Type
Drug
Intervention Name(s)
Silicone-based Film Forming Topical Gel
Other Intervention Name(s)
Silicone-based Film-forming Gel Dressing, StrataCTX, StrataXRT, StrataXRT Gel
Intervention Description
Applied topically
Intervention Type
Drug
Intervention Name(s)
Silver Sulfadiazine
Other Intervention Name(s)
Flamazine, Silvadene, Sliverex, SSD, Sulfadiazine Silver, Thermazene
Intervention Description
Applied topically
Intervention Type
Drug
Intervention Name(s)
Topical Hydrocortisone
Intervention Description
Applied topically
Primary Outcome Measure Information:
Title
Radiation dermatitis
Description
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame
Day 0 post-radiation therapy (RT)
Secondary Outcome Measure Information:
Title
Grade 2+ radiation dermatitis
Description
Will be assessed by CTCAE version 5.0.
Time Frame
Day 0 post-RT
Title
Grade 2+ radiation dermatitis
Description
Will be assessed by CTCAE version 5.0.
Time Frame
Day 6 +/- 1 post-RT
Title
Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores
Description
Will continue to assess CTCAE score for radiation dermatitis until resolution of symptoms.
Time Frame
Up to week 3 post-RT
Title
Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score
Time Frame
Up to week 3 post-RT
Title
Post-RT recovery time (to grade =< 1 radiation dermatitis
Description
Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame
Up until entire irradiated treatment site healed (grade =< 1 dermatitis)
Other Pre-specified Outcome Measures:
Title
Weekly Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) scores
Time Frame
Up to week 3 post-RT
Title
Average cost of StrataXRT tubes
Time Frame
Until healed (grade =< 1 dermatitis), up to 10 weeks
Title
Incidence of use of skin care products in addition to StrataXRT
Time Frame
Until healed (grade =< 1 dermatitis), up to 10 weeks
Title
Overall RT duration
Time Frame
Up to Day 0 post-RT
Title
Number of days missed (attributable to patient or provider concern re: dermatologic toxicity)
Time Frame
Up to Day 0 post-RT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josh Walker, M.D., Ph.D.
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josh Walker, M.D., Ph.D.
Phone
503-494-8756
Email
cooki@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Josh Walker, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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