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Trial record 1 of 1 for:    nuque 3 | France
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Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy (NUQUE3)

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

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
Official Title  ICMJE Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Other: Regular dietary support
Systematic and regular dietary support after radiotherapy
Study Arms  ICMJE
  • 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
    Intervention: Other: Regular dietary support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2016)
224
Actual Study Completion Date  ICMJE March 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02789267
Other Study ID Numbers  ICMJE 2015-A01684-45
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Hospital, Caen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Caen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University Hospital, Rouen
  • Centre Francois Baclesse
Investigators  ICMJE
Principal Investigator: Emmanuel BABIN, Pr University Hospital, Caen
PRS Account University Hospital, Caen
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP