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Trial record 97 of 363 for:    transthyretin

Nutritional Status Assessment in Head and Neck Cancer Patients Receiving Radiotherapy or Chemo-radiotherapy (NUTRINECK)

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ClinicalTrials.gov Identifier: NCT02900963
Recruitment Status : Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

Brief Summary:
Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. In this context, nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or gastrostomy) are often necessary. The early identification of the patients with high malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and efficacy of treatment. This prospective study research the factors of malnutrition during head and neck radiotherapy.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: weekly assessment of patient's weight Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy
Study Start Date : April 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Nutrition state determination

Determination of nutritional state and inflammatory status:

weekly assessment of patient's weight biological parameters (albumin, transthyretin, orosomucoid) and weekly assessment of patient's weight

Other: weekly assessment of patient's weight
Biological assessment to determine biological and inflammatory status Quality of life questionary




Primary Outcome Measures :
  1. weight [ Time Frame: one year ]
    Measure of weight ( in Kg)


Secondary Outcome Measures :
  1. Nutritional status determination [ Time Frame: 3 months ]
    Determination of nutritional status by assessing albuminemia

  2. Nutritional status determination [ Time Frame: 3 months ]
    Determination of nutritional status by assessing transthyretin

  3. Nutritional status determination [ Time Frame: 6 months ]
    Determination of nutritional status by assessing albuminemia

  4. Nutritional status determination [ Time Frame: 6 months ]
    Determination of nutritional status by assessing transthyretin

  5. Nutritional status determination [ Time Frame: One year ]
    Determination of nutritional status by assessing albuminemia

  6. Nutritional status determination [ Time Frame: One year ]
    Determination of nutritional status by assessing transthyretin

  7. Inflammatory status [ Time Frame: 3 months ]
    Determination of inflammatory status by assessing orosomucoid

  8. Inflammatory status [ Time Frame: 3 months ]
    Determination of inflammatory status by assessing CRP

  9. Inflammatory status [ Time Frame: 6 months ]
    Determination of inflammatory status by assessing orosomucoid

  10. Inflammatory status [ Time Frame: 6 months ]
    Determination of inflammatory status by assessing CRP

  11. Inflammatory status [ Time Frame: one year ]
    Determination of inflammatory status by assessing orosomucoid

  12. Inflammatory status [ Time Frame: one year ]
    Determination of inflammatory status by assessing CRP

  13. BMI calculation [ Time Frame: one year ]
    Calculation of BMI using height and weight



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

Inclusion Criteria:

  • Males or females older than 18 years
  • Performance Status 0 or 1 or 2
  • Locally advanced head and neck cancer treated with a curative intent treatment consisting of either concomitant chemo-radiotherapy or adjuvant radiation therapy or adjuvant chemo-radiotherapy.
  • Signed Informed Consent

Exclusion Criteria:

  • Other cancer or previous cancer within 2 years or evolutive cancer
  • Performance Status 3 or 4
  • NGT or PEG at screening period
  • Any legal, social, psychological reasons that could jeopardize the patient's compliance to the study constrains.

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 ClinicalTrials.gov identifier (NCT number): NCT02900963


Locations
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France
Centre Henri Becquerel
Rouen, France, 76038
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
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Principal Investigator: Sebastien Thureau, MD Centre Henri Becquerel

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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT02900963     History of Changes
Other Study ID Numbers: CHB 13.04
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Henri Becquerel:
Nutrition
Head and Neck Cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms