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Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA) (PETRA)

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ClinicalTrials.gov Identifier: NCT01374399
Recruitment Status : Active, not recruiting
First Posted : June 16, 2011
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
Information provided by (Responsible Party):
German Cancer Research Center

Brief Summary:

The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on prognosis, side-effects and complications after allogeneic stem cell transplantation.

The exercise intervention includes both, resistance and endurance training. Patients assigned to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen) and have the same frequency of social contact.


Condition or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Behavioral: exercise and relaxation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation
Study Start Date : February 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: resistance and endurance exercise Behavioral: exercise and relaxation
resistance and endurance exercise, 3-5 times per week
Active Comparator: relaxation Behavioral: exercise and relaxation
resistance and endurance exercise, 3-5 times per week



Primary Outcome Measures :
  1. Overall survival [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Fatigue [ Time Frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation ]
    measured by the Multidimensional Fatique Inventory (MFI)

  2. Quality of Life [ Time Frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation ]
    mesured by the European Organistion for Research and Treatment of Cancer questionnaire including the high dose chemotherapy module (EORTC-QLQ-C30/HDC-29)

  3. Hemoglobin, Leukocytes, Thrombocytes [ Time Frame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation ]
    Hematological and immunological reconstitution

  4. Side-effects (Infections, GvHD, Depression, Distress) [ Time Frame: during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation ]
    Depression mesured by "Allgemeine Depressionskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) Distress mesures by the NCCN Distress Thermometer

  5. Adherence to exercise protocol [ Time Frame: one year ]
    Fesability of an one-year exercise intervention after allogeneic HSCT

  6. Muscular strength [ Time Frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation ]
    measured at the IsoMed2000 and/or Handheld Dynamometer

  7. cardiorespiratory fitness [ Time Frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation ]
    measured by ergospirometry (VO2max) and/or 6 Minutes Walk Test (meters)

  8. IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin [ Time Frame: admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation ]
    Biomarker in blood and urine

  9. median survival, non-relapse mortality [ Time Frame: admission to hospital until 2 years after transplantation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical indication: allogeneic stem cell transplantation

Exclusion Criteria:

  • Orthopeadic limitations that hamper the exercise intervention
  • Osseous degenerations that have an improved fracture risk

Information from the National Library of Medicine

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): NCT01374399


Locations
Germany
German Cancer Research Center
Heidleberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
Investigators
Principal Investigator: Martin Bohus, Prof. MD Central Institute of Mental Health
Principal Investigator: Joachim Wiskemann, PhD National Center for Tumor Diseases
Study Chair: Dreger Peter, Prof. MD University Hospital Heidelberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01374399     History of Changes
Other Study ID Numbers: DJCLS R 10/42pf
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by German Cancer Research Center:
allogeneic stem cell transplantation
exercise
survival
fatigue
quality of life
cancer
physical performance