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

Last updated: July 26, 2023
Sponsor: Centre Francois Baclesse
Overall Status: Completed

Phase

3

Condition

Nasopharyngeal Cancer

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Treatment

bandage skin Hydrotac®

Ialuset®

Clinical Study ID

NCT01520701
IPAC
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 inresponders)
  • 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 orprogressive malignancy other
    • For patients with an indication of chemotherapy combined withradiotherapy,biological assessments compatible with chemotherapy:
  • WBC > 3000/mm3, Polynuclear > 2000/mm3,Platelets > 150,000/mm3, Creatinine lessthan 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

Exclusion Criteria:

  • Patient with a history of malignancy, outside a basal cell carcinoma or cervicalcancer 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 exceptionof 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) withor 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'sability to participate in the study
  • Inability to undergo medical test for geographical, social or psychological

Study Design

Total Participants: 125
Treatment Group(s): 2
Primary Treatment: bandage skin Hydrotac®
Phase: 3
Study Start date:
February 01, 2012
Estimated Completion Date:
October 31, 2022

Connect with a study center

  • CHU

    Caen, Calvados 14033
    France

    Site Not Available

  • Centre François BACLESSE

    Caen, Calvados 14076
    France

    Site Not Available

  • Centre Maurice TUBIANA

    Caen, Calvados 14000
    France

    Site Not Available

  • Chu Rouen

    Rouen, Seine Maritime 76 000
    France

    Site Not Available

  • Centre de la Baie

    Avranches,
    France

    Site Not Available

  • Clinique Leonard de Vinci

    Chambray les TOURS, 37000
    France

    Site Not Available

  • centre hospitalier du Cotentin

    Cherbourg,
    France

    Site Not Available

  • Centre Guillaume Le Conquérant

    Le Havre, 76000
    France

    Site Not Available

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