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

Radiation Dermatitis Clinical Trial

Official title:

A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05450848
• Other study ID #: SPASX01AU002
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2023
• Source: Stratpharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Device:
• StrataXRT
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.

Other:
• Sorbolene
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.

Locations

Country	Name	City	State
Australia	Townsville Cancer Center, Townsville Hospital and Health Service	Douglas	Queensland
Australia	Princess Alexandra Hospital	South Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Stratpharma AG

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Onset of radiation dermatitis	Timepoint of onset of CTCAE v4.0 radiation dermatitis Grades 2 and/or 3 during or after radiotherapy.	From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary	Length of time until resolution of radiation dermatitis	Length of time from peak incidence to resolution of radiation dermatitis.	From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Secondary	Patient reported symptoms treatment	Patient reported comfort scale obtained using the eviQ RISRAS form.	From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Secondary	Cost-effectiveness	The mean total cost of skin care per patient.	From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary	Incidence of late-effects skin toxicity	The late skin toxicity post-radiotherapy assessed using the Radiation Therapy Oncology Group (RTOG) grading definitions: Grade 0: No change over baseline Grade I: Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating Grade II: Tender or bright erythema, patchy moist desquamation, moderate oedema Grade III: Confluent, moist desquamation other than skin folds, pitting oedema Grade IV: Ulceration haemorrhage, necrosis	3 - 12 months post radiation treatment