NCT00375700WithdrawnNot Applicable
Efficacy of an Oral Nutrition Supplement on the Total Caloric and Protein Intake of Head and Neck Cancer Patients During the Last 2 Weeks of Radiation Therapy
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- AHS Cancer Control Alberta
- Primary Endpoint
- total energy and protein intake
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
total energy and protein intake
Time Frame: Study completion
Secondary Outcomes
No secondary outcomes reported
Investigators
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