Cardiopulmonary Fitness in Long-Term Survivors of HPV-related Oropharynx Cancers

January 2, 2018 updated by: Memorial Sloan Kettering Cancer Center

Pilot Study of Cardiopulmonary Fitness in Long-Term Survivors of HPV-related Oropharynx Cancers

This study is being done to learn about how the participants lungs and heart are working after treatment for throat cancer. The investigators are looking to see if there is a long-term impact on overall health from the cancer treatment. The long-term goal of this study is to compare the participants overall quality of life to similarly aged people who have not had throat cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is not to test the impact of a specific intervention, but rather to evaluate the long-term cardiovascular health and quality of life of oropharyngeal cancer survivors using validated survey instruments, cardiopulmonary testing, and measurements of cardiac risk factors. Thus, no intervention, other than the assessments will be administered as part of the protocol. All participants will have received treatment according to the standard of care or a therapeutic clinical trial in which they may have participated previously. We will collect information about prior treatment from the electronic medical record (EMR).

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In protocol 10-111 "Surviving Oropharynx Cancer: Long-term Impact of Human Papillomavirus (HPV) on quality of life", a population of HPV+ oropharyngeal cancer survivors was identified. There are nearly 150 participants who have completed the one-time questionnaire on 10-111 who may meet the eligibility criteria for this study.

Description

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of HPV+ squamous cell carcinoma of the oropharynx confirmed by the pathology department of MSKCC. Positive HPV status defined as chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and
  • 66) or p16 immunohistochemistry done in a Clinically Laboratory Improvement Amendment (CLIA) approved laboratory; if either of these 2 tests are positive, the patient is classified as HPV positive]
  • Completed last treatment for oropharyngeal cancer (surgery, chemotherapy, or radiation) at least 3 years before enrollment in study
  • Able to speak and read English
  • Clinically shows no evidence of disease (NED)
  • Received radiation therapy with a dose of at least 60Gy, at MSKCC as part of concurrent treatment
  • Medical clearance from a member of the patient's healthcare team indicating no relative contraindications to undergoing a cardiopulmonary exercise test

Exclusion Criteria:

  • Diagnosis with recurrent disease following completion of primary curative treatment
  • History of any cancer other than HPV+ oropharyngeal squamous cell carcinoma, or current diagnosis of another cancer
  • Current diagnosis of any of the following: Acute myocardial Infarction (within 3-5 days of any planned study procedures); Unstable angina; Arrhythmia; Syncope; Active endocarditis; Acute myocarditis or pericarditis; Symptomatic severe aortic stenosis; Heart failure; Acute pulmonary embolus or pulmonary infarction; Thrombosis of lower extremities; Suspected dissecting aneurysm; Pulmonary edema; Room air desaturation at rest ≤85%; Respiratory failure; Any acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis); COPD or asthma noted in patients EMR.
  • Mental impairment leading to an inability to cooperate or consent to this research study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
long-term survivors of HPV-related oropharyngeal cancer
This is a cross-sectional pilot study of long-term survivors of HPV-related oropharyngeal cancer treated with CTRT who are at least three years from treatment completion. This study consists of a onetime assessment of cardiopulmonary fitness, physical function status, measurement of lean body mass, endothelial function quality of life assessment, medical history and blood laboratory evaluation for traditional cardiac risk factors, endocrine derangement and inflammation.
Other: blood draw
Behavioral: study questionnaire
Other: cardiopulmonary exercise testing (CPET)
Other: DXA (dual-energy x-ray absorptiometry) scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in VO2peak
Time Frame: 1 year
using cardiopulmonary exercise testing
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Shrujal Baxi, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oropharynx Cancers

Clinical Trials on blood draw

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe