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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


Phase 3
18 Years
69 Years
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


Inclusion Criteria:



- Patient aged 18 years old and under 70

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome 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).

Outcome Time Frame:

end of radiotherapy

Safety Issue:

No

Principal Investigator

David BLANCHARD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IPAC

NCT ID:

NCT01520701

Start Date:

February 2012

Completion Date:

September 2019

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • Hydrosorb
  • radiodermatitis
  • algia
  • radiotherapy
  • Head and Neck Neoplasms

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