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Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy (NUQUE3)

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. Identifier: NCT02789267
Recruitment Status : Terminated (Insufficient funding)
First Posted : June 2, 2016
Last Update Posted : April 25, 2019
University Hospital, Rouen
Centre Francois Baclesse
Information provided by (Responsible Party):
University Hospital, Caen

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: Regular dietary support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Arm Intervention/treatment
No Intervention: Control

Group of patients with standard of care: the nutritional support is conducted by physicians.

No systematic dietary support

Experimental: Regular 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
Other: Regular dietary support
Systematic and regular dietary support after radiotherapy

Primary Outcome Measures :
  1. Patient's proportion presenting a decrease of 5% of their weight 6 months after the end of radiotherapy [ Time Frame: 6 months ]
    the weight will measured by physician just after radiotherapy and after 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02789267

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Caen University Hospital
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
University Hospital, Rouen
Centre Francois Baclesse
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Principal Investigator: Emmanuel BABIN, Pr University Hospital, Caen
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Responsible Party: University Hospital, Caen Identifier: NCT02789267    
Other Study ID Numbers: 2015-A01684-45
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Caen:
Head and Neck Cancer
Quality of Life
Dietary support
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site