StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

Stratpharma

Status: Completed

Conditions: Radiation Dermatitis

Treatments: Other: Sorbolene; Device: StrataXRT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05450848

SPASX01AU002

Details and patient eligibility

About

Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with cancer undergoing a curative course of radiation therapy using standard protocols to the following cancer sites:

  • Head and neck cancers receiving >= 60Gy who are not receiving concurrent Cetuximab
  • Intact breast receiving >= 40Gy (includes patients receiving boost fields using photon or elections)
  • Post-mastectomy chest wall (breast cancer diagnosis only) receiving >= 50Gy
  • Gynaecological cancers requiring whole pelvis irradiation receiving >= 45Gy
  • Skin cancers to the axilla/groin regions receiving >= 40Gy

• Male and female patients >18 years of age

• Patients who do not have a known allergy to silicon

• Patients who are able to attend the four post-treatment weekly skin assessment appointments

Exclusion criteria

Ineligible participants are patients undergoing a course of curative radiation therapy:

• Who are participating in another interventional study
• With an allergy to product content (standard or StrataXRT)
• With an existing skin rash, ulceration or open wound in the treatment area
• With a pre-existing systemic skin disease (dermatological conditions, connective tissue disorders)
• Who have had previous radiation therapy to the current treatment area
• Who are on immuno-suppression drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

StrataXRT

Experimental group

Description:

Patients allocated to receive StrataXRT will be provided with StrataXRT gel to apply twice daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided.

Treatment:

Device: StrataXRT

Standard of care

Active Comparator group

Description:

Patients allocated to receive standard care will be provided with aqueous cream to apply daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided.

Treatment:

Other: Sorbolene