NCT00375700

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2006

Typical duration for not_applicable head-and-neck-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 25, 2016

Status Verified

March 1, 2012

Enrollment Period

3.2 years

First QC Date

September 11, 2006

Last Update Submit

February 24, 2016

Conditions

Head and Neck Cancer

Keywords

fooddietoral supplementhead and neck cancerradiation

Outcome Measures

Primary Outcomes (1)

  • total energy and protein intake

    Study completion

Interventions

Nutritional SupplementDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Cathy Kubrak, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

November 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 25, 2016

Record last verified: 2012-03