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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05073172
Recruitment Status : Not yet recruiting
First Posted : October 11, 2021
Last Update Posted : May 11, 2022
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Kiri Cook, MD, OHSU Knight Cancer Institute

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


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 Name: Aquaphor

Other: Polyethylene Glycol Hydrogel
Applied topically
Other Name: PEG Hydrogel

Drug: Silver Sulfadiazine
Applied topically
Other Names:
  • Flamazine
  • Silvadene
  • Sliverex
  • SSD
  • Sulfadiazine Silver
  • Thermazene




Primary Outcome Measures :
  1. Radiation dermatitis [ Time Frame: Day 0 post-radiation therapy (RT) ]
    Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE).


Secondary Outcome Measures :
  1. Grade 2+ radiation dermatitis [ Time Frame: Day 0 post-RT ]
    Will be assessed by CTCAE version 5.0.

  2. Grade 2+ radiation dermatitis [ Time Frame: Day 6 +/- 1 post-RT ]
    Will be assessed by CTCAE version 5.0.

  3. Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores [ Time Frame: Up to week 3 post-RT ]
    Will continue to assess CTCAE score for radiation dermatitis until resolution of symptoms.

  4. Time to peak Common Terminology Criteria for Adverse Events (CTCAE) score [ Time Frame: Up to week 3 post-RT ]
  5. Post-RT recovery time (to grade =< 1 radiation dermatitis [ Time Frame: Up till entire irradiated treatment site healed (grade =< 1 dermatitis) ]
    Will be defined by Common Terminology Criteria for Adverse Events (CTCAE).


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05073172


Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Contact: Kiri A. Cook, MD    503-494-8756    cooki@ohsu.edu   
Principal Investigator: Kiri A. Cook, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
Investigators
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Principal Investigator: Kiri A Cook, MD OHSU Knight Cancer Institute
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Responsible Party: Kiri Cook, MD, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT05073172    
Other Study ID Numbers: STUDY00018789
NCI-2021-09431 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00018789 ( Other Identifier: OHSU Knight Cancer Institute )
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Skin Diseases
Neoplasms by Site
Breast Diseases
Radiation Injuries
Wounds and Injuries
Sulfadiazine
Silver Sulfadiazine
Petrolatum
Mineral Oil
Emollients
Dermatologic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local