Head and Neck CancerNCT00296452
Effect of a Nutritional Supplement on H&N Cancer Patients
A study testing behavior in people with Head and Neck Cancer, run by Edward Hines Jr. VA Hospital at 2 sites in United States.
Trial summary
To determine if using a nutritionally enhanced supplement will improve mucositis in head and neck cancer patients Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and neck cancer 1st.2nd wk Rx read \&wrte eng
Who cannot join
- receiving hospice impaired cognition
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141
Sharon Foley, MS, 708-202-2343 ext. 22343, Sharon.Foley@med.va.gov
- Suspended
Hines VA Hospital
Hines, Illinois, 60141
About this study
Official title: The Effect of an Enhanced Nutritional Supplement on Head and Neck Cancer Patients
To determine if using a nutritionally enhanced supplement will improve mucositis in head and neck cancer patients
Read the detailed description
H\&N cancer patients will be randomized to receive either a nutritionally enhanced product or standard treatment. The patients in both groups will receive nutritional counseling weekly by the RD. Anthropometric measures, available lab values, mucositis grade, and quality of life measures will be compared between groups.
- Conditions
- Head and Neck Cancer
- Being tested
- behavior
- Keywords
- cancer, nutrition
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behaviorBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of mucositis
Secondary outcomes (1)
weight loss, quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Edward Hines Jr. VA Hospital
- Sponsor type
- US federal agency
- Investigators
- Sharon Foley, MS, Principal investigator, Hines VA Hosptialcarol bier-laning, MD, Principal investigator, Hines VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296452
- Sponsor's protocol ID
- 0033
- Status last verified
- Feb 2006
- First submitted
- 23 Feb 2006
- Last updated
- 27 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Enhanced Nutritional Supplement on Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00296452
- Acronym / sponsor ID
- 0033
- Conditions
- Head and Neck Cancer
- Keywords
- cancer, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Edward Hines Jr. VA HospitalUS federal agency
- Study start
- Feb 2006
- Study completion
- Feb 2006
- First posted
- 27 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if using a nutritionally enhanced supplement will improve mucositis in head and neck cancer patients
Detailed description
H\&N cancer patients will be randomized to receive either a nutritionally enhanced product or standard treatment. The patients in both groups will receive nutritional counseling weekly by the RD. Anthropometric measures, available lab values, mucositis grade, and quality of life measures will be compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Head and neck cancer 1st.2nd wk Rx read \&wrte eng
Key exclusion criteria (1 listed)
- receiving hospice impaired cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavior | Behavioural | – |
Primary outcome
severity of mucositis
1 secondary outcome
weight loss, quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Foley, MS principal investigator
Hines VA Hosptial
carol bier-laning, MD principal investigator
Hines VA Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavior in people with Head and Neck Cancer, run by Edward Hines Jr. VA Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Foley, MS (708-202-2343 ext. 22343, Sharon.Foley@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of mucositis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2006.