Effect of an Oral Supplement on the Total Energy and Protein Intake of Head and Neck Cancer Patients in the Last 2 Weeks of Radiation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-01-31

Brief Summary

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In this study, an oral nutrition supplement has been developed that take into consideration: the nutritional requirements, treatment side-effects and taste preferences of head and neck cancer patients; the acceptance of a supplement when experiencing radiation therapy side-effects; and the taste preferences of head and neck cancer patients which may affect the supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation therapy.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx and thyroid.
* all histologic types of cancer
* all tumour stages according to American Joint Committee for Cancer (AJCC) Staging
* all forms of RT including standard or investigational for head and neck cancers
* alert and mentally competent
* English speaking

Exclusion Criteria

* an allergy or intolerance to any of the substances used in the nutrition supplement
* Type I or II diabetes mellitus
* renal insufficiency
* unable to swallow
* additional criteria of all forms of chemotherapy standard or investigational or combination of radiation/chemotherapy standard or investigational for head and neck cancers

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No