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 (IPAC)

This study is currently recruiting participants.
Verified January 2012 by Centre Francois Baclesse
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01520701
First received: January 13, 2012
Last updated: March 20, 2013
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Device: bandage skin Hydrosorb
Drug: Biafine®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • Impact of applying a bandage hydrogel skin on head and neck pains [ Time Frame: end of radiotherapy ] [ Designated as safety issue: No ]
    Assessing the impact of applying a bandage hydrogel skin on head and neck pains in patients with cancer of head and neck treated with concomitant radiotherapy by evaluating the proportion of patients with a deterioration in three or more points to their score algia EVA rating scale at the end of treatment compared to that obtained at baseline (D0).


Secondary Outcome Measures:
  • Evaluating the terms of issue of the treatment [ Time Frame: during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy ] [ Designated as safety issue: No ]
    Evaluating the terms of issue of the treatment (number of interruptions, longer duration of treatment, dose reduction therapeutic influence of psychosocial factors) and quality of life for patients.


Estimated Enrollment: 110
Study Start Date: February 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ialuset® application
Arm with application to the skin Ialuset ® cervical during radiotherapy
Drug: Biafine®
Patients randomized to receive reference of the application of cervical Biafine ® on skin throughout the treatment period (the first day to last day of radiotherapy).
Experimental: bandage skin Hydrosorb
Arm bandage skin hydrogel (Hydrosorb)on the skin cervical during radiotherapy
Device: bandage skin Hydrosorb
Patients randomized to the arm with bandage skin will benefit from the application of the bandage skin hydrogel (Hydrosorb ®) at least 5 hours per day for the duration of treatment (the first day last day of radiotherapy).

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged 18 years old and under 70
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520701

Contacts
Contact: David BLANCHARD, MD 02 31 45 40 13 d.blanchard@baclesse.fr

Locations
France
Centre François BACLESSE Recruiting
Caen, Calvados, France, 14076
Contact: David BLANCHARD, MD    02 31 45 50 02    d.blanchard@baclesse.fr   
Principal Investigator: David BLANCHARD, MD         
Sub-Investigator: Dominique DE RAUCOURT, MD         
Sub-Investigator: Jean-Pierre RAME, MD         
Sub-Investigator: Bernard GERY, MD         
Sub-Investigator: Carmen FLORESCU, MD         
Sub-Investigator: Radj GERVAIS, MD         
Sub-Investigator: Pascal DO, MD         
Sub-Investigator: Catherine DUBOS-ARVIS, MD         
CHU Not yet recruiting
Caen, Calvados, France, 14033
Contact: Emmanuel BABIN, PD         
Principal Investigator: Emmanuel BABIN, PD         
Sub-Investigator: Vincent PATRON, MD         
Sub-Investigator: Martin HITIER, MD         
Sub-Investigator: Aurélien MEUNIER, MD         
Sub-Investigator: Marjorie LOAEC, MD         
Centre Maurice TUBIANA Not yet recruiting
Caen, Calvados, France, 14000
Contact: Séverine GUARNIERI, MD         
Principal Investigator: Séverine GUARNIERI, MS         
Sponsors and Collaborators
Centre Francois Baclesse
Ministry of Health, France
Investigators
Principal Investigator: David BLANCHARD, MD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01520701     History of Changes
Other Study ID Numbers: IPAC
Study First Received: January 13, 2012
Last Updated: March 20, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
head and neck cancer
Hydrosorb
radiodermatitis
algia
radiotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 14, 2014