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

NCT05073172 | Withdrawn FDA Device

• 2 other identifiers: STUDY00018789NCI-2021-09431
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Radiation dermatitis

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

  Day 0 post-radiation therapy (RT)

Secondary Outcomes (5)

• Grade 2+ radiation dermatitis

  Day 0 post-RT

• Grade 2+ radiation dermatitis

  Day 6 +/- 1 post-RT

• Weekly Common Terminology Criteria for Adverse Events (CTCAE) scores

  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

  Up until entire irradiated treatment site healed (grade =< 1 dermatitis)

Other Outcomes (5)

• 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

Study Arms (2)

Arm I (StrataXRT)

EXPERIMENTAL

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

Arm II (standard of care)

ACTIVE COMPARATOR

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; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Polyethylene Glycol Hydrogel; Drug: Silver Sulfadiazine; Drug: Topical Hydrocortisone

Interventions

Calendula Ointment DRUG

Applied topically

Arm II (standard of care)

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment OTHER

Applied topically

Also known as: Aquaphor

Arm II (standard of care)

Polyethylene Glycol Hydrogel OTHER

Applied topically

Also known as: PEG Hydrogel

Arm II (standard of care)

Silicone-based Film Forming Topical Gel DRUG

Applied topically

Also known as: Silicone-based Film-forming Gel Dressing, StrataCTX, StrataXRT, StrataXRT Gel

Arm I (StrataXRT)

Silver Sulfadiazine DRUG

Applied topically

Also known as: Flamazine, Silvadene, Sliverex, SSD, Sulfadiazine Silver, Thermazene

Arm II (standard of care)

Topical Hydrocortisone DRUG

Applied topically

Arm II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Interventions

Petrolatum; Hydrogel, Polyethylene Glycol Dimethacrylate; Silver Sulfadiazine; Hydrocortisone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals; Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Nanogels; Polymers; Macromolecular Substances; Gels; Colloids; Complex Mixtures; Biomedical and Dental Materials; Hydrogels; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Sulfones; Sulfur Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Josh Walker, M.D., Ph.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 11, 2021
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

US (1)