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Impact of Applying a Bandage Skin Hydrogel on the Pains of the Head and Neck in Patients With Cancer of Head and Neck Treated With Radiotherapy

NCT01520701 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-07-27

No results posted yet for this study

Summary

The investigators hope to get by reduced and delayed acute radiodermatitis following the application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and improved quality of life of patients with head and neck cancer treated with concomitant radiotherapy.

Conditions

Interventions

DEVICE

bandage skin Hydrotac®

Patients randomized to the arm with bandage skin will benefit from the application of the bandage skin hydrogel (Hydrotac®) at least 5 hours per day for the duration of treatment (the first day last day of radiotherapy).

DRUG

Ialuset®

Patients randomized to receive reference of the application of cervical Ialuset® on skin throughout the treatment period (the first day to last day of radiotherapy).

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Centre Francois Baclesse

    lead OTHER

Principal Investigators

  • David BLANCHARD, MD · Centre François Baclesse

  • Audrey LASNE-CARDON, MD · Centre François Baclesse

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • France

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 NCT01520701 on ClinicalTrials.gov