Pancreatic CancerSUPPORTNCT01977066
Exercise Intervention Study for Pancreatic Cancer Patients
A study testing Six months supervised resistance training and Six months home-based exercise training in people with Pancreatic Cancer, run by German Cancer Research Center at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Six months supervised resistance training and Six months home-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Six months supervised resistance training, Six months home-based exercise training
- Keywords
- pancreatic cancer, exercise training, quality of life, physical functioning
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six months supervised resistance trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Six months supervised exercise training | Experimental | Not described Receives: Behavioral: Six months supervised resistance training |
| Six months home-based exercise training | Experimental | Not described Receives: Behavioral: Six months home-based exercise training |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning score, as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC QLQ-C30
Measured: 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)
Measured: change from Baseline to end of intervention (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Heidelberg Medical Center, Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Sponsor
- Investigators
- Karen G Steindorf, Prof. Dr., Principal investigator, German Cancer Research Center (DKFZ)/ German National Center for Tumor Diseases (NCT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977066
- Sponsor's protocol ID
- SUPPORT
- Acronym
- SUPPORT
- Status last verified
- Feb 2017
- First submitted
- 30 Oct 2013
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39606939Wochner 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.
PubMed 33253318Wiskemann 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.
PubMed 30589829
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial
- ClinicalTrials.gov ID
- NCT01977066
- Acronym / sponsor ID
- SUPPORT / SUPPORT
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, exercise training, quality of life, physical functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- University of Heidelberg Medical Center, Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six months supervised resistance trainingprogressive 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. | Behavioural | Six months supervised exercise training |
| Six months home-based exercise trainingHome-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. | Behavioural | Six months home-based exercise training |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Derived from this study: PubMed 39606939Ernst 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.
- Derived from this study: PubMed 33253318Wochner 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.
- Derived from this study: PubMed 30589829Wiskemann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen G Steindorf, Prof. Dr. principal investigator
German Cancer Research Center (DKFZ)/ German National Center for Tumor Diseases (NCT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six months supervised resistance training and Six months home-based exercise training in people with Pancreatic Cancer, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977066, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.