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Exercise Intervention Study for Pancreatic Cancer Patients (SUPPORT)

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Six months supervised resistance training
Six months home-based exercise training
Sponsored by
German Cancer Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring pancreatic cancer, exercise training, quality of life, physical functioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pancreatic cancer patients (stage I-IV)
  • Patients ≥ 18 years of age
  • Resection performed at the University Clinic of Heidelberg
  • Sufficient German language skills
  • Signed informed consent

Exclusion Criteria:

• Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)

Sites / Locations

  • German Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Six months supervised exercise training

Six months home-based exercise training

Control group

Arm Description

Outcomes

Primary Outcome Measures

Physical functioning score, as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC QLQ-C30

Secondary Outcome Measures

Overall quality of life from EORTC QLQ-C30 and the specific module for pancreatic cancer(QLQ-PAN26)

Full Information

First Posted
October 30, 2013
Last Updated
February 24, 2017
Sponsor
German Cancer Research Center
Collaborators
University of Heidelberg Medical Center, Deutsche Krebshilfe e.V., Bonn (Germany)
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1. Study Identification

Unique Protocol Identification Number
NCT01977066
Brief Title
Exercise Intervention Study for Pancreatic Cancer Patients
Acronym
SUPPORT
Official Title
SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Cancer Research Center
Collaborators
University of Heidelberg Medical Center, Deutsche Krebshilfe e.V., Bonn (Germany)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effects of two specific exercise interventions and one standard care control arm on physical functioning.The investigators expect that supervised training is most beneficial to the patients. However, they also expect some benefit for patients in the home-based training.
Detailed Description
The randomized-controlled balanced-parallel-group trial included 65 adult pancreatic cancer patients (stage I-IV) from the University Surgery Clinic in Heidelberg. The study compared two specific exercise interventions and one standard care control arm. The intervention programs were (1) a 6-month supervised moderate-to-high-intensity, progressive resistance training, and (2) a 6-month home-based exercise training. Thus, the two interventions differed primarily by the intensity and mode-of-administration of the intervention. Both interventions started at the earliest 8 weeks after surgery to allow for wound healing until Maximum 12 months after the surgery. The supervised progressive training started with only moderate-intensity training during the first 4 weeks. Only patients without comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability) were eligible. The primary objective is to compare the effects of the different interventions on physical functioning, measured as change from baseline to 6 months. Additional endpoints are overall quality of life, fatigue, endurance, and strength performance, adherence to the interventions, discontinuation of adjuvant therapy, body weight and composition, disease progression, overall and progression-free survival. All outcomes has been assessed every 3 months for a minimum follow-up period of 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, exercise training, quality of life, physical functioning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Six months supervised exercise training
Arm Type
Experimental
Arm Title
Six months home-based exercise training
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Six months supervised resistance training
Intervention Description
progressive resistance training (2x/week), starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery with only low-to-moderate-intensity training during the first 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Six months home-based exercise training
Intervention Description
Home-based exercise training (2x/week) with initial counseling and weekly telephone contact starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery.
Primary Outcome Measure Information:
Title
Physical functioning score, as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC QLQ-C30
Time Frame
Change from baseline to end of intervention (after 6 months)
Secondary Outcome Measure Information:
Title
Overall quality of life from EORTC QLQ-C30 and the specific module for pancreatic cancer(QLQ-PAN26)
Time Frame
change from Baseline to end of intervention (6 months)
Other Pre-specified Outcome Measures:
Title
Fatigue (Multidimensional Fatigue Inventory (MFI))
Time Frame
change from baseline to end of intervention (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pancreatic cancer patients (stage I-IV) Patients ≥ 18 years of age Resection performed at the University Clinic of Heidelberg Sufficient German language skills Signed informed consent Exclusion Criteria: • Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen G Steindorf, Prof. Dr.
Organizational Affiliation
German Cancer Research Center (DKFZ)/ German National Center for Tumor Diseases (NCT)
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Cancer Research Center
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33253318
Citation
Wochner R, Clauss D, Nattenmuller J, Tjaden C, Bruckner T, Kauczor HU, Hackert T, Wiskemann J, Steindorf K. Impact of progressive resistance training on CT quantified muscle and adipose tissue compartments in pancreatic cancer patients. PLoS One. 2020 Nov 30;15(11):e0242785. doi: 10.1371/journal.pone.0242785. eCollection 2020.
Results Reference
derived
PubMed Identifier
30589829
Citation
Wiskemann J, Clauss D, Tjaden C, Hackert T, Schneider L, Ulrich CM, Steindorf K. Progressive Resistance Training to Impact Physical Fitness and Body Weight in Pancreatic Cancer Patients: A Randomized Controlled Trial. Pancreas. 2019 Feb;48(2):257-266. doi: 10.1097/MPA.0000000000001221.
Results Reference
derived

Learn more about this trial

Exercise Intervention Study for Pancreatic Cancer Patients

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