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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/15/2016
Start Date:December 2015
Contact:Shrujal Baxi, MD, MPH
Phone:646-888-4236

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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.

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).

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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Shrujal Baxi, MD
Phone: 646-888-4236
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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