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

NCT02628912 | Withdrawn

• 1 other identifier: 15-277
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oropharynx Cancers

Keywords

Cardiopulmonary Fitness; Long-Term Survivors; 15-277; HPV; Survivors

Outcome Measures

Primary Outcomes (1)

• change in VO2peak

  using cardiopulmonary exercise testing

  1 year

Study Arms (1)

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

Interventions

blood draw OTHER

long-term survivors of HPV-related oropharyngeal cancer

study questionnaire BEHAVIORAL

long-term survivors of HPV-related oropharyngeal cancer

cardiopulmonary exercise testing (CPET) OTHER

long-term survivors of HPV-related oropharyngeal cancer

DXA (dual-energy x-ray absorptiometry) scan OTHER

long-term survivors of HPV-related oropharyngeal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• \) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Blood Specimen Collection; Exercise Test; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Study Officials

• Shrujal Baxi, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 4, 2018

Record last verified: 2018-01