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

NCT05450848 | Completed

• 1 other identifier: SPASX01AU002
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (2)

• Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  Radiation dermatitis reaction as assessed by blinded assessment of digital photographs using the CTCAE v4.0 radiation dermatitis grades. CTCAE v4.0 severity grades are categorical with 5 possible categories (1, 2, 3, 4, 5). Grade 1 represents the weakest form of radiation dermatitis. Higher CTCAE Grades represent increasing radiation dermatitis severity.

  From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months

• Radiation induced skin reaction assessment scale (RISRAS)

  Radiation dermatitis reaction as assessed by the clinician during patient consultations using the eviQ RISRAS form. RISRAS scale is continuous scale from 0 to 36, with higher RISRAS scores representing higher severity of radiation dermatitis.

  From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months

Secondary Outcomes (5)

• Onset of radiation dermatitis

  From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months

• Length of time until resolution of radiation dermatitis

  From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months

• Patient reported symptoms treatment

  From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months

• Cost-effectiveness

  From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months

• Incidence of late-effects skin toxicity

  3 - 12 months post radiation treatment

Study Arms (2)

StrataXRT

EXPERIMENTAL

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.

Device: StrataXRT

Standard of care

ACTIVE COMPARATOR

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.

Other: Sorbolene

Interventions

StrataXRT DEVICE

StrataXRT is a flexible wound dressing for the prevention and treatment of radiation dermatitis. It is in the form of a gel which, when applied, creates a protective film that maintains skin integrity. The product is used to relieve low grade inflammatory radiation changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes with open wound components, StrataXRT reduces pain, redness and heat and helps soothe the exposed skin areas. StrataXRT can be applied where skin integrity has been compromised and may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains Polydimethylsiloxanes, Siloxanes and Alkylmethyl Silicones and is transparent and odourless. It does not contain alcohols, parabens or fragrances. StrataXRT can be used with or without a secondary protective dressing. It is suitable for children and people with sensitive skin.

StrataXRT

Sorbolene OTHER

Aqueous cream (moisturizer) that soothes itchiness and dryness of the skin, and aids skin hydration. It is non-greasy, fragrance free, colour free, GMO free, paraben free and pH balanced.

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratpharma AG: lead

Study Sites (2)

Townsville Cancer Center, Townsville Hospital and Health Service

Douglas, Queensland, 4814, Australia

Location

Princess Alexandra Hospital

South Brisbane, Queensland, 4101, Australia

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Site investigators will load the digital photographs taken at each weekly assessment into each participant's MOSAIQ record. They will then send de-identified copies to the Central Trial Coordinator who will distribute them to the study investigators who will be performing the blinded assessment. Each weekly photograph will be independently assessed by two study investigators using the CTCAE 4.0 scale for radiation dermatitis (Appendix 1). The study investigators will complete the supplied photograph assessment form and return them to the Central Trial Coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 11, 2022
• Study Start: September 1, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Locations

AU (2)