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Completed

NCT Number: NCT01977066

Exercise Intervention Study for Pancreatic Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Cancer Research Center

Heidelberg, D-69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Six months supervised resistance training

Behavioral

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

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  1. Fatigue (Multidimensional Fatigue Inventory (MFI))

    Time frame: change from baseline to end of intervention (6 months)

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • University of Heidelberg Medical Center

Registry information

Official study title

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

Acronym: SUPPORT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2013
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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