NCT01252498

Brief Summary

This study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

December 2, 2010

Last Update Submit

February 3, 2014

Conditions

Cancer of the Head and NeckRadiotherapy

Keywords

Cancer of the head and neckRadiotherapyProstaglandins

Outcome Measures

Primary Outcomes (1)

  • Salivary levels of PGE2 and PGI2 during and after radiotherapy

    10 weeks after initiation of therapy

Secondary Outcomes (2)

  • Observed mucositis during and after radiotherapy

    10 weeks after initiation of radiotherapy

  • Patient reports of oral pain during and after radiation therapy

    10 weeks after initiation of radiotherapy

Study Arms (1)

Radiotherapy

Patients receiving radiotherapy or chemoradiotherapy for head and neck cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving radiotherapy or chemoradiotherapy for oral cancers. Consecutive patients will be invited to participate.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Biospecimen

Retention: NONE RETAINED

Saliva will be collected at 4 time points before, during, immediately after, and several weeks after radiotherapy for head and neck cancer.

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Claire Verschraegen, MD

    University of Vermont/Fletcher Allen Health Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

December 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

US(1)