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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01520701|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2012
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Device: bandage skin Hydrotac® Drug: Ialuset®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||September 2023|
Active Comparator: Ialuset® application
Arm with application to the skin Ialuset ® cervical during radiotherapy
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).
Experimental: bandage skin Hydrosorb
Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
Device: bandage 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).
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520701
|Centre Maurice TUBIANA|
|Caen, Calvados, France, 14000|
|Caen, Calvados, France, 14033|
|Centre François BACLESSE|
|Caen, Calvados, France, 14076|
|Centre de la Baie|
|Clinique Leonard de Vinci|
|Chambray les TOURS, France, 37000|
|centre hospitalier du Cotentin|
|Centre Guillaume Le Conquérant|
|Le Havre, France, 76000|
|Principal Investigator:||David BLANCHARD, MD||Centre François Baclesse|
|Principal Investigator:||Audrey LASNE-CARDON, MD||Centre François Baclesse|