Head and Neck CancerNCT00375180
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients
An observational study of Head and Neck Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Jan 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid
Who may be able to join
- 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 histological types of cancer
- All tumour stages according to American Joint Committee for Cancer (AJCC) Staging
- All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers
- Alert and mentally competent
- English speaking
Who cannot join
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients Prior to, on Completion of and Six Weeks After Oncology Treatment
The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.
Read the detailed description
Head and neck cancer patients often have difficulty meeting their nutritional needs while undergoing radiation therapy (RT) and/or chemotherapy (RTchemo). Tumor locations and side effects of RT or RTchemo, including dry mouth, mouth sores, difficulty chewing and swallowing, changes in taste and smell, and loss of appetite, lead to poor food intake and weight loss. The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.
- Conditions
- Head and Neck Cancer
- Keywords
- food, diet, mucositis, xerostomia, dysphagia, taste, smell, head and neck, radiation, chemotherapy
- Medical subject headings
- Head and Neck Neoplasms, Mucositis, Xerostomia, Deglutition Disorders, Anosmia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionJan 2012
- Study completionJan 2012
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Vickie Baracos, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375180
- Sponsor's protocol ID
- HN-4-0030 / 23028
- Status last verified
- Mar 2012
- First submitted
- 11 Sep 2006
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients Prior to, on Completion of and Six Weeks After Oncology Treatment
- ClinicalTrials.gov ID
- NCT00375180
- Acronym / sponsor ID
- HN-4-0030 / 23028
- Conditions
- Head and Neck Cancer
- Keywords
- food, diet, mucositis, xerostomia, dysphagia, taste, smell, head and neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Nov 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Sep 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.
The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.
Detailed description
Head and neck cancer patients often have difficulty meeting their nutritional needs while undergoing radiation therapy (RT) and/or chemotherapy (RTchemo). Tumor locations and side effects of RT or RTchemo, including dry mouth, mouth sores, difficulty chewing and swallowing, changes in taste and smell, and loss of appetite, lead to poor food intake and weight loss. The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid
Key inclusion criteria (7 listed)
- 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 histological types of cancer
- All tumour stages according to American Joint Committee for Cancer (AJCC) Staging
- All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers
Key exclusion criteria (1 listed)
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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.
Vickie Baracos, MD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
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 7 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: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 25 Feb 2016.