Exercise Intervention Study for Pancreatic Cancer Patients (SUPPORT)

• ClinicalTrials.gov Identifier: NCT01977066
• Recruitment Status: Completed
• First Posted: November 6, 2013
• Last Update Posted: February 27, 2017
• Sponsor: German Cancer Research Center
• Collaborators: University of Heidelberg Medical Center; Deutsche Krebshilfe e.V., Bonn (Germany)
• Information provided by (Responsible Party): German Cancer Research Center

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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Behavioral: Six months supervised resistance training; Behavioral: Six months home-based exercise training	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial
• Study Start Date: November 2013
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Six months supervised exercise training	Behavioral: Six months supervised resistance training; 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.
Experimental: Six months home-based exercise training	Behavioral: Six months home-based exercise training; 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.
No Intervention: Control group

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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 Outcome Measures:

1. Fatigue (Multidimensional Fatigue Inventory (MFI)) [ Time Frame: change from baseline to end of intervention (6 months) ]

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Germany

German Cancer Research Center

Heidelberg, Germany, D-69120

Sponsors and Collaborators

German Cancer Research Center

University of Heidelberg Medical Center

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

• Principal Investigator: Karen G Steindorf, Prof. Dr.; German Cancer Research Center (DKFZ)/ German National Center for Tumor Diseases (NCT)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: German Cancer Research Center
• ClinicalTrials.gov Identifier: NCT01977066
• Other Study ID Numbers: SUPPORT
• First Posted: November 6, 2013
• Last Update Posted: February 27, 2017
• Last Verified: February 2017

Keywords provided by German Cancer Research Center:

pancreatic cancer; exercise training; quality of life; physical functioning

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases