Exercise Intervention Study for Pancreatic Cancer Patients

Pancreatic Cancer Clinical Trial

— SUPPORT  

Official title:

SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977066
• Other study ID #: SUPPORT
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: February 24, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
German Cancer Research Center	Deutsche Krebshilfe e.V., Bonn (Germany), University of Heidelberg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatigue (Multidimensional Fatigue Inventory (MFI))		change from baseline to end of intervention (6 months)
Primary	Physical functioning score, as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC QLQ-C30		Change from baseline to end of intervention (after 6 months)
Secondary	Overall quality of life from EORTC QLQ-C30 and the specific module for pancreatic cancer(QLQ-PAN26)		change from Baseline to end of intervention (6 months)

External Links

•   Working group Physical activity and cancer at the German Cancer Research Center