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

• Sponsor: German Cancer Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01374399
• Collaborator: National Center for Tumor Diseases, Heidelberg (Other), University Hospital Heidelberg (Other), Central Institute of Mental Health, Mannheim (Other)
• Enrollment: 267
• Location: 1
• Arms: 2
• Actual Duration (Months): 100.9
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 267 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
• Actual Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall survival [two years]

Secondary Outcome Measures

1. Fatigue [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 [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 [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) [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 [one year]

   Fesability of an one-year exercise intervention after allogeneic HSCT

6. Muscular strength [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 [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 [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 [admission to hospital until 2 years after transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: German Cancer Research Center
• ClinicalTrials.gov Identifier: NCT01374399
• Other Study ID Numbers: DJCLS R 10/42pf
• First Posted: Jun 16, 2011
• Last Update Posted: Dec 24, 2019
• Last Verified: Dec 1, 2019

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

Study Results

No Results Posted as of Dec 24, 2019