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EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial (EXPECT)

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ClinicalTrials.gov Identifier: NCT01853202
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Susan Lakoski, University of Vermont

Study Description
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Brief Summary:
Patients with lymphoma or cancer who are receiving chemotherapy in the outpatient setting are at risk for blood clots which form in the veins. The occurrence of blood clots has major implications on personal health including the need for blood thinners and monitoring, potential bleeding, and complications related to blood clots on cardiovascular health. The goal of this study is to determine whether aerobic exercise training is a therapeutic strategy to offset risk of blood clots and improve quality of life among cancer patients during chemotherapy.

Condition or disease Intervention/treatment Phase
Cancer Thrombosis Behavioral: Supervised aerobic exercise training Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial
Study Start Date : March 2013
Actual Primary Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1 - Supervised aerobic exercise training
This group will participate in 3 supervised exercise sessions/week at an intensity of 50%-70% of the individually determined VO2max between 30-45 min/session for 12 weeks. The aerobic training intervention will closely mimic the standard exercise-based guidelines adopted in cardiac rehabilitation. All intervention sessions will be performed in a supervised setting with one-on-one supervision by an American College of Sports Medicine-certified exercise physiologist. Aerobic exercise training will be prescribed based on the guiding ACSM principles with the aim of improving VO2max. Walking was chosen because it is the preferred mode of exercise training in cancer patients.
 Behavioral: Supervised aerobic exercise training
No Intervention: Group 2
The 12-week program will consist of monthly phone contacts to check in with patient and review their exercise log entries for that month in order to capture physical activity done outside of the intervention setting.


Outcome Measures
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Primary Outcome Measures :
  1. Thrombin Generation [ Time Frame: 12 weeks ]
    The primary endpoint will be thrombin generation, a marker of VTE risk in cancer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of lymphoma or cancer
  • Beginning chemotherapy regimen
  • Patient self-report of ability to walk 10 minutes without interruption or pain
  • Age >18 and <80
  • Willingness to participate in the oncology rehabilitation program at Tilley Drive South Burlington

Exclusion Criteria:

  • Presence or history of DVT or PE prior to entry
  • Antithrombotic therapy including warfarin, dabigatran, low molecular weight heparin or unfractionated heparin which will alter levels of hemostatic factors (Off Lovenox 48 hours before first study blood draw)
  • Medical condition that alters ability to walk for exercise
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853202


Locations
United States, Vermont
Fletcher Allen Healthcare
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Susan G Lakoski, MD University of Vermont
More Information
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Publications:

Responsible Party: Susan Lakoski, Assistant Professor, University of Vermont College of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT01853202     History of Changes
Other Study ID Numbers: VCC 1220
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Susan Lakoski, University of Vermont:
Cancer
Chemotherapy
Thrombosis
Prevention
Exercise

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases