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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ialuset® application

Arm with application to the skin Ialuset ® cervical during radiotherapy

Group Type ACTIVE_COMPARATOR

Ialuset®

Intervention Type DRUG

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).

bandage skin Hydrosorb

Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy

Group Type EXPERIMENTAL

bandage skin Hydrotac®

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient aged 18 years old
* Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door
* Patient treated by one of the following diagrams

* radiotherapy alone
* postoperative radiotherapy + / - sensitized platinum (cisplatin or carboplatin)
* ar chemoradiation 5-FU and platinum (the Cetuximab is not allowed)
* diagram organ preservation (induction chemotherapy and radiotherapy in responders)
* Untreated patients
* Patient should receive conventional radiotherapy or tomotherapy
* Adapted stomatological care
* Life expectancy \> 3 months
* WHO score \< 2
* Patient stable, not having the time of the examination of evidence of recurrent or progressive malignancy other
* \- For patients with an indication of chemotherapy combined with radiotherapy,biological assessments compatible with chemotherapy:

* WBC \> 3000/mm3, Polynuclear \> 2000/mm3,Platelets \> 150,000/mm3, Creatinine less than 2 times normal; Bilirubin less than 2.5 times normal
* Patient fluent in French
* Affiliation to a system of social security
* Patient has given written consent

Exclusion Criteria

* Patient with a history of malignancy, outside a basal cell carcinoma or cervical cancer treated and cured
* Patient has at the time of examination signs of recurrence or other neoplasia scalable
* Patient with a history of prior chemotherapy or radiation therapy with the exception of the scheme of organ preservation (induction chemotherapy before radiation)
* For patients with an indication of chemotherapy combined with radiotherapy, contraindication to treatment with specific platinum (cisplatin or carboplatin) with or without 5 Fluorouracil
* Infectious diseases uncontrolled
* Patient is pregnant or lactating or absence of contraception during their reproductive
* Patient hypertensive unbalanced under antihypertensive treatment
* Uncontrolled cardiac disease
* Patients with renal or hepatic
* Known allergy to any component of Ialuset ®
* Patient deprived of liberty under guardianship
* Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
* Inability to undergo medical test for geographical, social or psychological

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No