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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)

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
bandage skin Hydrotac®
Ialuset®
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring head and neck cancer, Hydrotac®, radiodermatitis, algia, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Maurice TUBIANA
  • CHU
  • Centre François BACLESSE
  • Centre de la Baie
  • Clinique Leonard de Vinci
  • centre hospitalier du Cotentin
  • Centre Guillaume Le Conquérant

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ialuset® application

bandage skin Hydrosorb

Arm Description

Arm with application to the skin Ialuset ® cervical during radiotherapy

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

Outcomes

Primary Outcome Measures

Impact of applying a bandage hydrogel skin on head and neck pains
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
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.

Full Information

First Posted
January 13, 2012
Last Updated
July 26, 2023
Sponsor
Centre Francois Baclesse
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01520701
Brief 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
Acronym
IPAC
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
October 2022 (Actual)
Study Completion Date
October 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, Hydrotac®, radiodermatitis, algia, radiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ialuset® application
Arm Type
Active Comparator
Arm Description
Arm with application to the skin Ialuset ® cervical during radiotherapy
Arm Title
bandage skin Hydrosorb
Arm Type
Experimental
Arm Description
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
Intervention Type
Device
Intervention Name(s)
bandage skin Hydrotac®
Intervention Description
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
Drug
Intervention Name(s)
Ialuset®
Intervention Description
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).
Primary Outcome Measure Information:
Title
Impact of applying a bandage hydrogel skin on head and neck pains
Description
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).
Time Frame
end of radiotherapy
Secondary Outcome Measure Information:
Title
Evaluating the terms of issue of the treatment
Description
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.
Time Frame
during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David BLANCHARD, MD
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Audrey LASNE-CARDON, MD
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Maurice TUBIANA
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Facility Name
CHU
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Facility Name
Centre François BACLESSE
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Centre de la Baie
City
Avranches
Country
France
Facility Name
Clinique Leonard de Vinci
City
Chambray les TOURS
ZIP/Postal Code
37000
Country
France
Facility Name
centre hospitalier du Cotentin
City
Cherbourg
Country
France
Facility Name
Centre Guillaume Le Conquérant
City
Le Havre
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

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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

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