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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00375700
• Other study ID #: HN-4-0029 / 23027
• Status: Withdrawn
• Phase: N/A
• First received: September 11, 2006
• Last updated: February 24, 2016
• Start date: November 2006
• Est. completion date: January 2010

Study information

• Verified date: March 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• Nutritional Supplement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total energy and protein intake		Study completion