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Completed

NCT Number: NCT01520701

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

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.

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Key information

Conditions

Head and Neck Cancer Dermatitis Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU, Caen, Calvados, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: IPAC

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2012
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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