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NCT00508170 Clinical Trial

Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection

Head and Neck Cancer Clinical Trial

Official title:
Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00508170
Other study ID # 2005-0519
Secondary ID
Status Completed
Phase N/A
First received July 25, 2007
Last updated July 27, 2012
Start date March 2006
Est. completion date January 2010

Study information
Verified date July 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Primary Objectives:

1. To determine whether high-risk sexual behaviors are more common in patients with oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.

2. To determine if high-risk sexual behaviors are more common in patients with HPV (human papillomavirus) associated head and neck cancer than those without evidence of HPV-16 infection.

Description:

Squamous cell cancer of the head and neck (SCCHN) is believed to be caused by the long-term exposure of the mucous membrane on the inside of the mouth to different types of cancer-causing agents. This results in changes in the mouth, which can lead to the development of cancer.

Infection with HPV-16 has been linked with SCCHN. Half of all cancers of the oropharynx (the middle part of the throat including the soft palate, base of the tongue, and tonsils) are caused by HPV-16. HPV-16 is normally sexually transmitted, and is the cause of cervical cancer in women. By finding out if the virus is also sexually transmitted to the oropharynx, doctors may be able to educate patients about risk factors for developing cancer in this region. Eventually, doctors may be able to vaccinate people who are at risk for getting this virus.

You have received this questionnaire because you gave researchers your verbal consent for the mail-out. Along with the questionnaire, included are 2 self-addressed stamped envelopes for you to return the questionnaire and consent separately.

If you agree to take part in this study, you will complete the questionnaire about your sexual history such as specific sexual practices and number of partners, exposure to HPV and other viruses, and any relevant medical history. This questionnaire should take about 10 minutes to complete. The questionnaire will be given a study code number so that your name or M. D. Anderson patient ID number will not appear on the questionnaire.

Once you have finished the questionnaire, for added privacy and confidentiality, you should place the signed consent form in 1 self-addressed stamped envelope (SASE) and the completed questionnaire into the other self-addressed stamped envelope (SASE) that has been provided. Please mail both envelopes back within 15 days of receiving the questionnaire.

Once you have completed the questionnaire, your participation in this study is over.

This is an investigational study. About 1,267 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.

Recruitment information / eligibility
Status Completed
Enrollment 252
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients with diagnosed squamous cell carcinoma of the head and neck that participated in the molecular epidemiology study LAB00-062 of head and neck cancer between 1995 and 2005.

2. Head and Neck cancer participants of LAB00-062 that are still alive.

3. Head and Neck cancer participants of LAB00-062 that have known mailing addresses in the U.S.A.

4. Patients must be 18 years and older.

5. Patients will have completed their primary treatment but may be undergoing treatment for a second primary or recurrent disease.

6. Ability to read, write, and speak Spanish or English.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• Questionnaire
The questionnaire contains 23 questions and is estimated to take approximately 10 minutes to complete.

Locations
Country Name City State
United States UT MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Responders with High-risk Sexual Behaviors Written self-administered questionnaire responses analyzed to determine whether patients with oropharyngeal cancer have history of high-risk sexual behavior (defined as 15 or more lifetime sexual partners) greater than that of patients with tumors of other sites of head and neck 1 month for mailing and return of questionnaires No
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