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

NCT01520701 | Completed Phase 3

• 1 other identifier: IPAC
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 7

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; Hydrotac®; radiodermatitis; algia; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  end of radiotherapy

Secondary Outcomes (1)

• Evaluating the terms of issue of the treatment

  during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy

Study Arms (2)

Ialuset® application

ACTIVE COMPARATOR

Arm with application to the skin Ialuset ® cervical during radiotherapy

Drug: Ialuset®

bandage skin Hydrosorb

EXPERIMENTAL

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

Device: bandage skin Hydrotac®

Interventions

bandage skin Hydrotac® 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).

bandage skin Hydrosorb

Ialuset® 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).

Ialuset® application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• Ministry of Health, France: collaborator

Study Sites (7)

Centre Maurice TUBIANA

Caen, Calvados, 14000, France

Location

CHU

Caen, Calvados, 14033, France

Location

Centre François BACLESSE

Caen, Calvados, 14076, France

Location

Centre de la Baie

Avranches, France

Location

Clinique Leonard de Vinci

Chambray-lès-Tours, 37000, France

Location

centre hospitalier du Cotentin

Cherbourg, France

Location

Centre Guillaume Le Conquérant

Le Havre, 76000, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• David BLANCHARD, MD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

• Audrey LASNE-CARDON, MD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 30, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

FR (7)