NCT01977066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

October 30, 2013

Last Update Submit

February 24, 2017

Conditions

Pancreatic Cancer

Keywords

pancreatic cancerexercise trainingquality of lifephysical functioning

Outcome Measures

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

    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)

    change from Baseline to end of intervention (6 months)

Other Outcomes (1)

  • Fatigue (Multidimensional Fatigue Inventory (MFI))

    change from baseline to end of intervention (6 months)

Study Arms (3)

Six months supervised exercise training

EXPERIMENTAL
Behavioral: Six months supervised resistance training

Six months home-based exercise training

EXPERIMENTAL
Behavioral: Six months home-based exercise training

Control group

NO INTERVENTION

Interventions

Six months supervised resistance trainingBEHAVIORAL

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 supervised exercise training
Six months home-based exercise trainingBEHAVIORAL

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.

Six months home-based exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Cancer Research Center

Heidelberg, D-69120, Germany

Location

Related Publications (3)

  • Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

    PMID: 39606939DERIVED

  • 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.

    PMID: 33253318DERIVED

  • 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.

    PMID: 30589829DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Karen G Steindorf, Prof. Dr.

    German Cancer Research Center (DKFZ)/ German National Center for Tumor Diseases (NCT)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

DE(1)