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

Withdrawn

• Conditions: Oropharynx Cancers
• Interventions: Other: blood draw; Behavioral: study questionnaire; Other: cardiopulmonary exercise testing (CPET); Other: DXA (dual-energy x-ray absorptiometry) scan

• Registration Number: NCT02628912
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-11
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
long-term survivors of HPV-related oropharyngeal cancer	cardiopulmonary exercise testing (CPET)	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.
long-term survivors of HPV-related oropharyngeal cancer	blood draw	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.
long-term survivors of HPV-related oropharyngeal cancer	study questionnaire	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.
long-term survivors of HPV-related oropharyngeal cancer	DXA (dual-energy x-ray absorptiometry) scan	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.

Primary Outcome Measures

Name	Time	Method
change in VO2peak	1 year	using cardiopulmonary exercise testing