Head and Neck CancerNCT00577902
Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation
An observational study of Head and Neck Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
This study is being conducted to define the specific nutritional biomarkers and nutritional risk during the course of chemoradiation therapy for cancers of the head and neck. This prospective, longitudinal observational study is focused on specific antioxidants and B vitamins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Observation
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Nov 2010
- 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: Patients presenting at the UAMS Head and Neck Clinic will be invited to participate in this study according to the inclusion criteria listed:
Methodology. Patients presenting at the UAMS Head and Neck Clinic will be invited to participate in this study according to the inclusion criteria listed:
- Age over 18 years,
- Pathologically proven squamous cell carcinomas of the head and neck, except nasopharyngeal and sinus
- Concurrent radiation and chemotherapy (taxotere/carboplatin)
- Karnofsky score over60
- Must receive radiation (IMRT)/chemotherapy at UAMS
- No evidence of metastatic disease
- No significant cardiac, chest, gastrointestinal or renal morbidities
- No previous chemotherapy or radiation If they are considered eligible and agree to participate, the patients will be registered and sign informed consent form. Radiation and chemotherapy will commence on the same day. IMRT is the only modality of radiation allowed. Blood samples will be collected and nutritional risk evaluated, using the Patient-Generated Subjective Global Assessment tool (PG-SGA). The PG-SGA and blood tests will be performed before, at the end of XRT treatment and four to six weeks after treatment is completed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
This study is being conducted to define the specific nutritional biomarkers and nutritional risk during the course of chemoradiation therapy for cancers of the head and neck. This prospective, longitudinal observational study is focused on specific antioxidants and B vitamins. The ORAC was selected as an index of overall antioxidant capacity. We chose to evaluate antioxidant status because administering antioxidants has been shown to reduce chemotherapeutic agent toxicities.
Read the detailed description
The study will include 60, ≥18 year old patients (of both genders) with head and neck cancers receiving concurrent radiation and chemotherapy treatment. Patients with any pathologically proven head and neck squamous cell carcinoma, except those of the nasopharynx and sinus will be eligible, if there is no evidence of metastatic disease. Patients with previous chemotherapy or radiation treatment will be excluded. A Karnofsky performance status ≥60% or more is required. Patients with significant cardiac, chest or gastrointestinal comorbidities will be excluded, as will those who have had previous chemotherapy or radiation treatment. Patients may receive standard nutritional care, as needed.
This study will involve an examination of the patient to evaluate mucositis, collection blood samples for analysis of specific indicators of nutritional status and completion of questionnaire regarding food intake and functional status. Blood samples will be collected and brief questionnaires about diet and weight status will be completed at each of the three visits. Visits will occur before treatment begins, at the end of XRT treatment and 4-6 weeks after completion of XRT. Assessments for the presence and severity of mucositis and functional status (Karnofsky) will be done at each visit. All of the samples and data collection will be done at visits to clinic required for the patients' treatment. If it is necessary to obtain blood samples from the central venous catheter, this will be done using aseptic technique and will be performed by a nurse. In some instances, the information obtained as part of this project may be used to reduce side effects of therapy.
- Conditions
- Head and Neck Cancer
- Being tested
- Observation
- Keywords
- head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Head and neck cancer patients receiving chemoradiation
| Study group | Role | What they receive |
|---|---|---|
| Observational | This is an observational study Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study baseline antioxidant capacity (ORAC), selected biomarkers of nutritional status and nutritional risk of patients beginning therapy for head and neck cancers.
Secondary outcomes (1)
To assess antioxidant capacity, nutritional biomarkers and nutritional risk of patients during and after concurrent radiation and chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJun 2005
- Primary completionNov 2010
- Study completionNov 2010
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.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Hine, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577902
- Sponsor's protocol ID
- IRB# 41011
- Status last verified
- Feb 2016
- First submitted
- 18 Dec 2007
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Risk and Mucositis in Patients With Head and Neck Carcinoma Receiving Chemoradiation
- ClinicalTrials.gov ID
- NCT00577902
- Acronym / sponsor ID
- IRB# 41011
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Dec 2007 (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.
This study is being conducted to define the specific nutritional biomarkers and nutritional risk during the course of chemoradiation therapy for cancers of the head and neck. This prospective, longitudinal observational study is focused on specific antioxidants and B vitamins. The ORAC was selected as an index of overall antioxidant capacity. We chose to evaluate antioxidant status because administering antioxidants has been shown to reduce chemotherapeutic agent toxicities.
Detailed description
The study will include 60, ≥18 year old patients (of both genders) with head and neck cancers receiving concurrent radiation and chemotherapy treatment. Patients with any pathologically proven head and neck squamous cell carcinoma, except those of the nasopharynx and sinus will be eligible, if there is no evidence of metastatic disease. Patients with previous chemotherapy or radiation treatment will be excluded. A Karnofsky performance status ≥60% or more is required. Patients with significant cardiac, chest or gastrointestinal comorbidities will be excluded, as will those who have had previous chemotherapy or radiation treatment. Patients may receive standard nutritional care, as needed.
This study will involve an examination of the patient to evaluate mucositis, collection blood samples for analysis of specific indicators of nutritional status and completion of questionnaire regarding food intake and functional status. Blood samples will be collected and brief questionnaires about diet and weight status will be completed at each of the three visits. Visits will occur before treatment begins, at the end of XRT treatment and 4-6 weeks after completion of XRT. Assessments for the presence and severity of mucositis and functional status (Karnofsky) will be done at each visit. All of the samples and data collection will be done at visits to clinic required for the patients' treatment. If it is necessary to obtain blood samples from the central venous catheter, this will be done using aseptic technique and will be performed by a nurse. In some instances, the information obtained as part of this project may be used to reduce side effects of therapy.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationThis is an observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at the UAMS Head and Neck Clinic will be invited to participate in this study according to the inclusion criteria listed:
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 |
|---|---|---|
| ObservationHead and neck cancer patients receiving chemoradiation | Other | Observational |
Primary outcome
To study baseline antioxidant capacity (ORAC), selected biomarkers of nutritional status and nutritional risk of patients beginning therapy for head and neck cancers.
1 secondary outcome
To assess antioxidant capacity, nutritional biomarkers and nutritional risk of patients during and after concurrent radiation and chemotherapy.
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 9 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.
Jean Hine, PhD principal investigator
University of Arkansas
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 University of Arkansas at 1 site 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?
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 9 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 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?
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.
What does the primary outcome measure?
To study baseline antioxidant capacity (ORAC), selected biomarkers of nutritional status and nutritional risk of patients beginning therapy for head and neck cancers.. 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 9 Feb 2016.