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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01520701

Acronym

IPAC

Enrollment

130

Registered

2012-01-30

Start date

2012-02-01

Completion date

2022-10-01

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

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

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.

Interventions

DEVICEbandage 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).

DRUGIaluset®

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Impact of Applying a Bandage Hydrogel Skin on Head and Neck Pains	end of radiotherapy (2 months after inclusion)	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

Measure	Time frame	Description
Chemotherapy Dose Reduction	during 36 months after radiotherapy	Evaluating the terms of issue of the treatment (dose reduction of chemothrapy treatment)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDavid BLANCHARD, MD

Centre François Baclesse

PRINCIPAL_INVESTIGATORAudrey LASNE-CARDON, MD