StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients

NCT03394417 | Recruiting

• 1 other identifier: 2016/01084
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IV, prospective, double-blind, randomized controlled trial with 2 study arms. The study population will be patients receiving chemoradiation for head and neck carcinomas, the majority of whom will be outpatients unless they require inpatient supportive care during treatment. There will be a 12 to 14-week longitudinal follow-up with 9 assessments conducted during this follow-up. The estimated duration of recruitment will be 6-8 years. Intervention group If a patient is allocated to the intervention group following randomization, the patient will be treated with StrataXRT. Control group If a patient is allocated to the control group following randomization, the patient will be treated with standard clinical practice which consists of aqueous cream.

Conditions

Head and Neck Cancers; Acute Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• grade 2 acute radiation dermatitis

  when patient develops grade 2 acute radiation dermatitis as scored by Common Terminology Criteria for Adverse Event (CTCAE) version 4.03 scale with grade 1 the mildest, Grade 1: faint erythema or dry desquamation Grade 2: moderate to brisk erythema; patchy moist desquamation; moderate edema Grade 3: moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site Grade 5: death

  10 weeks

Secondary Outcomes (1)

• completion of scheduled post-treatment assessment at 6 weeks post-radiotherapy

  12 weeks

Study Arms (2)

standard clinical practice (control)

NO INTERVENTION

aqueous cream normally prescribed by radiation oncologists

StrataXRT (intervention)

ACTIVE COMPARATOR

silicon-based gel for radiation dermatitis

Device: StrataXRT

Interventions

StrataXRT DEVICE

randomized patient allocated to this group will receive StrataXRT for application during the treatment and 4 weeks further after the treatment ends.

StrataXRT (intervention)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are 21 years of age or older
• histological diagnosis of head and neck carcinoma available
• patients who are to be treated with concurrent chemoradiation
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
• no known allergy to StrataXRT or silicone
• able to give written informed consent, or have written consent given on their behalf

You may not qualify if:

• patients who cannot apply the skin product or have it administered to them
• patients with comorbidities and/or on medications that may alter the response of the skin e.g. connective tissue disorder
• patients with existing rashes or wounds in the radiation field at baseline
• patients receiving concurrent cetuximab during radiotherapy
• previous radiotherapy to the head and neck region
• female patients who are pregnant or breast feeding
• unable to give written informed consent , or are unable to have written consent given on their behalf

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• David Chia

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Chia

CONTACT

67737888; david_chia@nuhs.edu.sg

Fatin Aliyah Binte Hussin

CONTACT

67723079; fatin_hussin@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: November 8, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

SG (1)