Trial record 1 of 1 for:    NCT01853202
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EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Vermont
Sponsor:
Information provided by (Responsible Party):
Susan Lakoski, University of Vermont
ClinicalTrials.gov Identifier:
NCT01853202
First received: May 9, 2013
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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 Intervention
Cancer Thrombosis
Behavioral: Supervised aerobic exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Thrombin Generation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary endpoint will be thrombin generation, a marker of VTE risk in cancer.


Estimated Enrollment: 54
Study Start Date: March 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853202

Contacts
Contact: Elizabeth Eldridge 802-656-2178 elizabeth.eldridge@med.uvm.edu

Locations
United States, Vermont
Fletcher Allen Healthcare Recruiting
Burlington, Vermont, United States, 05401
Contact: Elizabeth Eldridge    802-656-2178    elizabeth.eldridge@med.uvm.edu   
Principal Investigator: Susan G Lakoski, MD         
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Susan G Lakoski, MD University of Vermont
  More Information

Publications:
Ay C, Dunkler D, Simanek R, Thaler J, Koder S, Marosi C, Zielinski C, Pabinger I. Prediction of venous thromboembolism in patients with cancer by measuring thrombin generation: Results from the vienna cancer and thrombosis study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2011;29:2099-2103
Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012;366:601-609
Kahn SR, Lim W, Dunn AS, Cushman M, Dentali F, Akl EA, Cook DJ, Balekian AA, Klein RC, Le H, Schulman S, Murad MH. Prevention of vte in nonsurgical patients: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest. 2012;141:e195S-226S
Patnaik JL, Byers T, Diguiseppi C, Denberg TD, Dabelea D. The influence of comorbidities on overall survival among older women diagnosed with breast cancer. Journal of the National Cancer Institute. 2011;103:1101-1111
Zwicker JI, Furie BC, Furie B. Cancer-associated thrombosis. Critical reviews in oncology/hematology. 2007;62:126-136
Goldenberg N, Kahn SR, Solymoss S. Markers of coagulation and angiogenesis in cancer-associated venous thromboembolism. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2003;21:4194-4199

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
Study First Received: May 9, 2013
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014