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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 (IPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520701
Recruitment Status : Active, not recruiting
First Posted : January 30, 2012
Last Update Posted : July 21, 2021
Ministry of Health, France
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: bandage skin Hydrotac® Drug: Ialuset® Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : February 2012
Actual Primary Completion Date : February 2020
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ialuset® application
Arm with application to the skin Ialuset ® cervical during 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).

Experimental: bandage skin Hydrosorb
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
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).

Primary Outcome Measures :
  1. Impact of applying a bandage hydrogel skin on head and neck pains [ Time Frame: end of radiotherapy ]
    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 :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520701

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Centre Maurice TUBIANA
Caen, Calvados, France, 14000
Caen, Calvados, France, 14033
Centre François BACLESSE
Caen, Calvados, France, 14076
Centre de la Baie
Avranches, France
Clinique Leonard de Vinci
Chambray les TOURS, France, 37000
centre hospitalier du Cotentin
Cherbourg, France
Centre Guillaume Le Conquérant
Le Havre, France, 76000
Sponsors and Collaborators
Centre Francois Baclesse
Ministry of Health, France
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Principal Investigator: David BLANCHARD, MD Centre François Baclesse
Principal Investigator: Audrey LASNE-CARDON, MD Centre François Baclesse
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Responsible Party: Centre Francois Baclesse Identifier: NCT01520701    
Other Study ID Numbers: IPAC
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Keywords provided by Centre Francois Baclesse:
head and neck cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site