Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy (NUQUE3)
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Regular dietary support
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Quality of Life, Dietary support
Eligibility Criteria
Inclusion Criteria:
- patients with first head and neck cancer histologically proved
- treatment by radiotherapy
- no sign of recidive
- life expectancy 3-month-old superior
- OMS score < 3
- french speaking
Exclusion Criteria:
- other former cancer
- pregnant woman
- no oral feeding before radiotherapy
- uncontrolled infectious pathology
Sites / Locations
- Caen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Regular dietary support
Arm Description
Group of patients with standard of care: the nutritional support is conducted by physicians. No systematic dietary support
Group of patients will benefit from a systematic and regular dietary support. Patients will be followed by a dietitian 1 month and 3 month after radiotherapy in hospital. Then, dietitian will realize a telephon interview 2 and 5 months after radiotherapy
Outcomes
Primary Outcome Measures
Patient's proportion presenting a decrease of 5% of their weight 6 months after the end of radiotherapy
the weight will measured by physician just after radiotherapy and after 6 months
Secondary Outcome Measures
Full Information
NCT ID
NCT02789267
First Posted
March 17, 2016
Last Updated
April 24, 2019
Sponsor
University Hospital, Caen
Collaborators
University Hospital, Rouen, Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT02789267
Brief Title
Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
Acronym
NUQUE3
Official Title
Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funding
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
University Hospital, Rouen, Centre Francois Baclesse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of the patients at the time of the diagnosis. According to the recommendations of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five percent loss of weight compared to the previous weight increases the risk of toxicity of the chemotherapy and worsens the patient's quality of life.
The treatment of the tumors of the head and the neck comes along very often with a loss of weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.) which varies with the chosen treatment, and shows a major risk at the patients whose therapeutic sequence involves a radiotherapy. The irradiation of the upper aerodigestive tract is source of aftereffects and late complications: xerostomia, oedemas of mucous membranes.
The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of the patients. It reveals or even increases, a dysphagia. According to Woisard, six months after the end of treatments, forty percent of the patients suffer from a dysphagia.
All these complications limit quantitatively and qualitatively the food intake. The adaptation of the texture of the food is necessary by fifty four percent at three months of the end of treatments according to Logemann et al., and a few patients remain dependent on an long term enteral nutrition.
Beyond a change of the nutritional state, the feeding difficulties or even the absence of resumption of an oral feeding are responsible for a social isolation. The meal which lost its dimension of pleasure becomes a source of fear and obsession for the patient as well as for his relations, and this fact generates family tensions. The quality of life of the patient is heavily affected.
Ravasco showed in his study that the impact on the nutritional state of a nutritional care by dietary advices was more important as the prescription of oral nutritional supplements but based on a short period (the dietary intervention covered only the duration of the radiotherapy). But what would happen after the end of treatments? The investigators emit the hypothesis that a post-therapeutic systematic and regular dietary support has a positive impact on the prevention of the undernutrition among the patients affected by a first cancer of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.
Detailed Description
The investigators propose a prospective randomized, open and multicentric study. This study has to include 224 patients affected by a head and neck cancer which therapeutic sequence involves a more or less made sensitized radiotherapy. The beginning of the inclusions is planned for May 2016, the end of inclusion 36 months later.
The nutritional state and quality of life will be evaluated 6 months after radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and Neck Cancer, Quality of Life, Dietary support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group of patients with standard of care: the nutritional support is conducted by physicians.
No systematic dietary support
Arm Title
Regular dietary support
Arm Type
Experimental
Arm Description
Group of patients will benefit from a systematic and regular dietary support. Patients will be followed by a dietitian 1 month and 3 month after radiotherapy in hospital. Then, dietitian will realize a telephon interview 2 and 5 months after radiotherapy
Intervention Type
Other
Intervention Name(s)
Regular dietary support
Intervention Description
Systematic and regular dietary support after radiotherapy
Primary Outcome Measure Information:
Title
Patient's proportion presenting a decrease of 5% of their weight 6 months after the end of radiotherapy
Description
the weight will measured by physician just after radiotherapy and after 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with first head and neck cancer histologically proved
treatment by radiotherapy
no sign of recidive
life expectancy 3-month-old superior
OMS score < 3
french speaking
Exclusion Criteria:
other former cancer
pregnant woman
no oral feeding before radiotherapy
uncontrolled infectious pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel BABIN, Pr
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
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