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Colorectal CarcinomaNCT01210313

Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma

An observational study of Colorectal Carcinoma, run by Austrian Breast & Colorectal Cancer Study Group at 7 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

feasibility of physical activity increase of physical conversation Quality of Life (optional) vascular and metabolic effects Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Carcinoma
What is being tested?
Physical exercise
How many people
30 participants
Where
7 sitesAustria
Study dates
Oct 2010to Apr 2013
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Study population: subjects with localised colorectal carcinoma

Who may be able to join

  • complete resected, histologically confirmed adeno carcinoma of colon or rectal and condition after (neo-)adjuvant therapy either in (1) stage III or (2) stage II with risk factor
  • 4-16 weeks after the end of an adjuvant chemotherapy
  • ECOG 0,1
  • Age > 18 years
  • adequate liver-, nephro- and hemogram parameters
  • physical eligibility

Who cannot join

  • significant comorbidities which exclude the participation
  • evidence of local recurrence or distant metastases
  • non-compliance of subject
  • other malignancy within the last 5 years (except: skin basalioma, cervix carcinoma in situ)
  • clinically significant cardiovascular diseases
  • treatment with beta blocker without possibility of adjustment
Show all 9Show fewer
  • left bundle-branch block
  • simultaneous chemotherapy or radiotherapy
  • pregnancy

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Austria7 sites

  • Medical University Innsbruck, Internal Medicine

    Innsbruck, Tyrol, 6020

  • District Hospital Kufstein

    Kufstein, Tyrol, 6330

  • AKH Linz

    Linz, Upper Austria, 4020

  • State Hospital Rankweil

    Rankweil, Vorarlberg, 6830

  • Hospital BHB St. Veit/Glan, Surgery

    Saint Veit A. D. Glan, Carinthia, 9330

  • Paracelsus Medical University Salzburg-Oncology, Coop. Group

    Salzburg, 5020

  • Klinikum Wels-Grieskirchen

    Wels, Upper Austria, 4600

Other trials in Austria

About this study

  • feasibility of physical activity
  • increase of physical conversation
  • Quality of Life (optional)
  • vascular and metabolic effects
Read the detailed description

In this phase II pilot project the feasibility of a defined medical physical activity should be verified for increased physical conversation. The study is conducted multicentric (single group) with a study population of 30 patients. After completion of adjuvant chemotherapy the patients will participate a defined physical training, 3 times per week within a time period of 52 weeks. Planned study duration 2 years.

Being tested
Physical exercise
Keywords
physical activity
Medical subject headings
Colorectal Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exerciseOther

    Defined exercise program

Study groups in NCT01210313
Study groupRoleWhat they receive
Physical exerciseNo treatment, only physical examinations accompanying physical exercise
Receives: Other: Physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Physical Activity After 12 Weeks (3 Months)

    Evaluation of the feasibility measured in terms of training adherence during the first 12 weeks measured in actual participant-weeks in relation to the 360 planned participant-weeks during cycle 1 (week 1 to week 12)

    Measured: 3 months

  2. Feasibility of Physical Activity After 26 Weeks (6 Months)

    Evaluation of the feasibility measured in terms of training adherence during the weeks 13 to 26 measured in actual participant-weeks in relation to the planned 420 participant-weeks during cycle 2 (week 13 to week 26)

    Measured: 6 months

  3. Feasibility of Physical Activity After 52 Weeks (12 Months)

    Evaluation of the feasibility measured in terms of training adherence during the weeks 27 to 52 measured in actual participant-weeks in relation to the planned 780 participant-weeks during cycle 3 (week 27 to week 52)

    Measured: 12 months

Secondary outcomes (9)

  1. Exercise Ergometry Activity After 12 Weeks (3 Months)

    Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 12 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 10 METs during cycle 1 (week 1 to week 12)

    Measured: 3 months

  2. Exercise Ergometry Activity After 26 Weeks (6 Months)

    Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 26 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 15 METs during cycle 2 (week 13 to week 26)

    Measured: 6 months

  3. Exercise Ergometry Activity After 52 Weeks (12 Months)

    Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 52 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 18 METs during cycle 3 (week 27 to week 52)

    Measured: 12 months

  4. Adiponectin at Screening

    Evaluation of adiponectin at screening as baseline for a description of changes during the study

    Measured: Day 1 (at screening)

  5. Adiponectin After 12 Weeks (3 Months)

    Evaluation of adiponectin after 12 weeks (3 months) for a description of changes during the study

    Measured: 3 months

  6. Adiponectin After 52 Weeks (12 Months)

    Evaluation of adiponectin after 52 weeks (12 months) for a description of changes during the study

    Measured: 12 months

  7. Leptin at Screening

    Evaluation of leptin at screening as baseline for a description of changes during the study

    Measured: Day 1 (at screening)

  8. Leptin After 12 Weeks (3 Months)

    Evaluation of leptin after 12 weeks (3 months) for a description of changes during the study

    Measured: 3 months

  9. Leptin After 52 Weeks (12 Months)

    Evaluation of leptin after 52 weeks (12 months) for a description of changes during the study

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01210313
Sponsor's protocol ID
ABCSG C07
Other IDs
EXERCISE
Status last verified
Apr 2024
First submitted
23 Sep 2010
Last updated
19 Sep 2024
Data monitoring committee
No

Publications

  • Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006 Aug 1;24(22):3527-34. doi: 10.1200/JCO.2006.06.0855. Epub 2006 Jul 5.

    PubMed 16822844

  • Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whittom R, Hantel A, Schilsky RL, Fuchs CS. Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol. 2006 Aug 1;24(22):3535-41. doi: 10.1200/JCO.2006.06.0863. Epub 2006 Jul 5.

    PubMed 16822843

  • Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.

    PubMed 15914748

  • Demark-Wahnefried W. Cancer survival: time to get moving? Data accumulate suggesting a link between physical activity and cancer survival. J Clin Oncol. 2006 Aug 1;24(22):3517-8. doi: 10.1200/JCO.2006.06.6548. Epub 2006 Jul 5. No abstract available.

    PubMed 16822842

  • Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. doi: 10.1079/bjn19780152.

    PubMed 718832

  • Hoeger W, Hoeger S. Principles and Labs for Physical Fitness. Morton Publishing Company, first edition 1999

  • O'Donovan G, Owen A, Bird SR, Kearney EM, Nevill AM, Jones DW, Woolf-May K. Changes in cardiorespiratory fitness and coronary heart disease risk factors following 24 wk of moderate- or high-intensity exercise of equal energy cost. J Appl Physiol (1985). 2005 May;98(5):1619-25. doi: 10.1152/japplphysiol.01310.2004. Epub 2005 Jan 7.

    PubMed 15640382

  • Haber Paul. Leitfaden zur medizinischen Trainingsberatung - Rehabilitation bis Leistungssport. 3. Auflage 2009; Springer Wien New York

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Carcinoma, run by Austrian Breast & Colorectal Cancer Study Group at 7 sites in Austria.

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 6 inclusion and 9 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Physical Activity After 12 Weeks (3 Months) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT01210313, which also lists 8 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 19 Sep 2024.

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