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

NCT ID: NCT01210313

Last Updated: 2024-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* feasibility of physical activity
* increase of physical conversation
* Quality of Life (optional)
* vascular and metabolic effects

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical exercise

No treatment, only physical examinations accompanying physical exercise

Physical exercise

Intervention Type OTHER

Defined exercise program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical exercise

Defined exercise program

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* left bundle-branch block
* simultaneous chemotherapy or radiotherapy
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Austrian Breast & Colorectal Cancer Study Group

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Josef Thaler, MD

Role: STUDY_CHAIR

Austrian Breast & Colorectal Cancer Study Group

Michael Fridrik, MD

Role: STUDY_CHAIR

Austrian Breast & Colorectal Cancer Study Group

Alfred Fridrik, MD

Role: STUDY_CHAIR

Austrian Breast & Colorectal Cancer Study Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, Austria

Site Status

Medical University Innsbruck, Internal Medicine

Innsbruck, Tyrol, Austria

Site Status

District Hospital Kufstein

Kufstein, Tyrol, Austria

Site Status

AKH Linz

Linz, Upper Austria, Austria

Site Status

Klinikum Wels-Grieskirchen

Wels, Upper Austria, Austria

Site Status

State Hospital Rankweil

Rankweil, Vorarlberg, Austria

Site Status

Paracelsus Medical University Salzburg-Oncology, Coop. Group

Salzburg, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16822844 (View on PubMed)

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.

Reference Type RESULT
PMID: 16822843 (View on PubMed)

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.

Reference Type RESULT
PMID: 15914748 (View on PubMed)

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.

Reference Type RESULT
PMID: 16822842 (View on PubMed)

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.

Reference Type RESULT
PMID: 718832 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 15640382 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EXERCISE

Identifier Type: OTHER

Identifier Source: secondary_id

ABCSG C07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.