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

NCT03394417 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-12

No results posted yet for this study

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

Interventions

DEVICE

StrataXRT

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

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • David Chia · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03394417 on ClinicalTrials.gov