Cancer of the Head and NeckNCT01252498
Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis
An observational study of Cancer of the Head and Neck and Radiotherapy, run by University of Vermont at 1 site in United States.
Trial summary
This study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck, Radiotherapy
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 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: Patients receiving radiotherapy or chemoradiotherapy for oral cancers. Consecutive patients will be invited to participate.
Who may be able to join
- Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Receiving radiation therapy or chemoradiation therapy to the oropharynx
- Older than 18 years old
- ECOG performance status of 0-2
- Life expectancy greater than 2 months
- Signed informed consent
Who cannot join
- Previous chemotherapy for this malignancy
- Previous radiotherapy to the head and neck
- Other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer
- Patient taking NSAIDs
Trial locations and contacts
1 site in 1 country.
United States1 site
Fletcher Allen Health Care
Burlington, Vermont, 05401
About this study
Official title: A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients
This study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.
Read the detailed description
Oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. However the mechanisms that induce such mucositis are not completely understood. Previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis.
The present study will measure the levels in saliva of the prostaglandins PGE2 and PGI2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. These salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels.
Improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.
- Conditions
- Cancer of the Head and Neck, Radiotherapy
- Keywords
- Cancer of the head and neck, Radiotherapy, Prostaglandins
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary levels of PGE2 and PGI2 during and after radiotherapy
Measured: 10 weeks after initiation of therapy
Secondary outcomes (2)
Observed mucositis during and after radiotherapy
Measured: 10 weeks after initiation of radiotherapy
Patient reports of oral pain during and after radiation therapy
Measured: 10 weeks after initiation of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Verschraegen, University of Vermont
- Investigators
- Claire Verschraegen, MD, Principal investigator, University of Vermont/Fletcher Allen Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252498
- Sponsor's protocol ID
- VCC1005
- Status last verified
- Feb 2014
- First submitted
- 2 Dec 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01252498
- Acronym / sponsor ID
- VCC1005
- Conditions
- Cancer of the Head and Neck, Radiotherapy
- Keywords
- Cancer of the head and neck, Radiotherapy, Prostaglandins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Dec 2010 (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 will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.
Detailed description
Oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. However the mechanisms that induce such mucositis are not completely understood. Previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis.
The present study will measure the levels in saliva of the prostaglandins PGE2 and PGI2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. These salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels.
Improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | – | –Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving radiotherapy or chemoradiotherapy for oral cancers. Consecutive patients will be invited to participate.
Key inclusion criteria (6 listed)
- Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Receiving radiation therapy or chemoradiation therapy to the oropharynx
- Older than 18 years old
- ECOG performance status of 0-2
- Life expectancy greater than 2 months
Key exclusion criteria (4 listed)
- Previous chemotherapy for this malignancy
- Previous radiotherapy to the head and neck
- Other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer
- Patient taking NSAIDs
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
Salivary levels of PGE2 and PGI2 during and after radiotherapy
Time frame: 10 weeks after initiation of therapy
2 secondary outcomes
Observed mucositis during and after radiotherapy
Time frame: 10 weeks after initiation of radiotherapy
Patient reports of oral pain during and after radiation therapy
Time frame: 10 weeks after initiation of radiotherapy
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 4 Feb 2014.
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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.
Claire Verschraegen, MD principal investigator
University of Vermont/Fletcher Allen Health Care
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 Cancer of the Head and Neck and Radiotherapy, run by University of Vermont 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?
The sponsor lists 6 inclusion and 4 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 4 Feb 2014. 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?
Salivary levels of PGE2 and PGI2 during and after radiotherapy (time frame: 10 weeks after initiation of therapy). 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 4 Feb 2014.