Nutritional Status Assessment in Head and Neck Cancer Patients Receiving Radiotherapy or Chemo-radiotherapy
NUTRINECK
Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy
1 other identifier
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Apr 2014
Typical duration for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
September 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 30, 2020
July 1, 2020
4.3 years
July 28, 2016
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight
Measure of weight ( in Kg)
one year
Secondary Outcomes (13)
Nutritional status determination
3 months
Nutritional status determination
3 months
Nutritional status determination
6 months
Nutritional status determination
6 months
Nutritional status determination
One year
- +8 more secondary outcomes
Study Arms (1)
Nutrition state determination
OTHERDetermination of nutritional state and inflammatory status: weekly assessment of patient's weight biological parameters (albumin, transthyretin, orosomucoid) and weekly assessment of patient's weight
Interventions
Biological assessment to determine biological and inflammatory status Quality of life questionary
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Henri Becquerel
Rouen, 76038, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastien Thureau, MD
Centre Henri Becquerel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
September 15, 2016
Study Start
April 1, 2014
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share