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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by German Cancer Research Center
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
ClinicalTrials.gov Identifier:
NCT01374399
First received: April 18, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on side-effects, complications and prognosis 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 Intervention Phase
Allogeneic Stem Cell Transplantation
Behavioral: exercise and relaxation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of an One-year Physical Exercise Intervention on Side-effects, Complications and Prognosis After Allogeneic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: one and two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    measured by the Multidimensional Fatique Inventory (MFI)

  • 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 ] [ Designated as safety issue: No ]
    mesured by the European Organistion for Research and Treatment of Cancer questionnaire including the high dose chemotherapy module (EORTC-QLQ-C30/HDC-29)

  • 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 ] [ Designated as safety issue: No ]
    Hematological and immunological reconstitution

  • 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 ] [ Designated as safety issue: No ]
    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

  • Adherence to exercise protocol [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Fesability of an one-year exercise intervention after allogeneic HSCT

  • 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 ] [ Designated as safety issue: No ]
    measured at the IsoMed2000 and/or Handheld Dynamometer

  • 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 ] [ Designated as safety issue: No ]
    measured by ergospirometry (VO2max) and/or 6 Minutes Walk Test (meters)

  • 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 ] [ Designated as safety issue: No ]
    Biomarker in blood and urine


Estimated Enrollment: 230
Study Start Date: February 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01374399

Contacts
Contact: Joachim Wiskemann, Dr. +49 6221 565904 joachim.wiskemann@nct-heidelberg.de
Contact: Rea Kuehl +49 6221 5636180 rea.kuehl@nct-heidelberg.de

Locations
Germany
German Cancer Research Center Recruiting
Heidleberg, Germany, 69120
Contact: Joachim Wiskemann, Dr.    +49 6221-565904    joachim.wiskemann@nct-heidelberg.de   
Contact: Rea Kuehl    +49 6221 5636180    rea.kuehl@nct-heidlebrg.de   
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
  More Information

No publications provided

Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01374399     History of Changes
Other Study ID Numbers: DJCLS R 10/42pf
Study First Received: April 18, 2011
Last Updated: December 10, 2013
Health Authority: Germany: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014