Head and Neck Cancer Clinical Trial
— NUTRINECKOfficial title:
Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy
NCT number | NCT02900963 |
Other study ID # | CHB 13.04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | December 2018 |
Verified date | July 2020 |
Source | Centre Henri Becquerel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | December 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Henri Becquerel | Rouen |
Lead Sponsor | Collaborator |
---|---|
Centre Henri Becquerel |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weight | Measure of weight ( in Kg) | one year | |
Secondary | Nutritional status determination | Determination of nutritional status by assessing albuminemia | 3 months | |
Secondary | Nutritional status determination | Determination of nutritional status by assessing transthyretin | 3 months | |
Secondary | Nutritional status determination | Determination of nutritional status by assessing albuminemia | 6 months | |
Secondary | Nutritional status determination | Determination of nutritional status by assessing transthyretin | 6 months | |
Secondary | Nutritional status determination | Determination of nutritional status by assessing albuminemia | One year | |
Secondary | Nutritional status determination | Determination of nutritional status by assessing transthyretin | One year | |
Secondary | Inflammatory status | Determination of inflammatory status by assessing orosomucoid | 3 months | |
Secondary | Inflammatory status | Determination of inflammatory status by assessing CRP | 3 months | |
Secondary | Inflammatory status | Determination of inflammatory status by assessing orosomucoid | 6 months | |
Secondary | Inflammatory status | Determination of inflammatory status by assessing CRP | 6 months | |
Secondary | Inflammatory status | Determination of inflammatory status by assessing orosomucoid | one year | |
Secondary | Inflammatory status | Determination of inflammatory status by assessing CRP | one year | |
Secondary | BMI calculation | Calculation of BMI using height and weight | one year |
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