Exercise Intervention Study for Pancreatic Cancer Patients

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Behavioral: Six months supervised resistance training; Behavioral: Six months home-based exercise training

• Registration Number: NCT01977066
• Lead Sponsor: German Cancer Research Center

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.

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study Start: 2013-11
• Study First Posted: 2013-11-06
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Six months supervised exercise training	Six months supervised resistance training	-
Six months home-based exercise training	Six months home-based exercise training	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

German Cancer Research Center; 🇩🇪 Heidelberg, Germany