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| ID | Type | Description | Link |
|---|---|---|---|
| EXERCISE | Other Identifier | ABCSG |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical exercise | No treatment, only physical examinations accompanying physical exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Other | Defined exercise program |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| 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) | 6 months |
| 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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subjects with localised colorectal carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Josef Thaler, MD | Austrian Breast & Colorectal Cancer Study Group | Study Chair |
| Michael Fridrik, MD | Austrian Breast & Colorectal Cancer Study Group | Study Chair |
| Alfred Fridrik, MD | Austrian Breast & Colorectal Cancer Study Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital BHB St. Veit/Glan, Surgery | Saint Veit A. D. Glan | Carinthia | 9330 | Austria | ||
| Medical University Innsbruck, Internal Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16822844 | Result | 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. | |
| 16822843 | Result | 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. |
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The first participant was enrolled October 7, 2010, the last participant was enrolled March 22, 2012. Enrollment took place in 7 Austrian clinical sites. In total, 30 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Exercise | No treatment, only physical examinations accompanying physical exercise (defined exercise program) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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) |
| 6 months |
| 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) | 12 months |
| Adiponectin at Screening | Evaluation of adiponectin at screening as baseline for a description of changes during the study | Day 1 (at screening) |
| Adiponectin After 12 Weeks (3 Months) | Evaluation of adiponectin after 12 weeks (3 months) for a description of changes during the study | 3 months |
| Adiponectin After 52 Weeks (12 Months) | Evaluation of adiponectin after 52 weeks (12 months) for a description of changes during the study | 12 months |
| Leptin at Screening | Evaluation of leptin at screening as baseline for a description of changes during the study | Day 1 (at screening) |
| Leptin After 12 Weeks (3 Months) | Evaluation of leptin after 12 weeks (3 months) for a description of changes during the study | 3 months |
| Leptin After 52 Weeks (12 Months) | Evaluation of leptin after 52 weeks (12 months) for a description of changes during the study | 12 months |
| Innsbruck |
| Tyrol |
| 6020 |
| Austria |
| District Hospital Kufstein | Kufstein | Tyrol | 6330 | Austria |
| AKH Linz | Linz | Upper Austria | 4020 | Austria |
| Klinikum Wels-Grieskirchen | Wels | Upper Austria | 4600 | Austria |
| State Hospital Rankweil | Rankweil | Vorarlberg | 6830 | Austria |
| Paracelsus Medical University Salzburg-Oncology, Coop. Group | Salzburg | 5020 | Austria |
| 15914748 | Result | 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. |
| 16822842 | Result | 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. |
| 718832 | Result | 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. |
| Result | Hoeger W, Hoeger S. Principles and Labs for Physical Fitness. Morton Publishing Company, first edition 1999 |
| 15640382 | 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. |
| Result | Haber Paul. Leitfaden zur medizinischen Trainingsberatung - Rehabilitation bis Leistungssport. 3. Auflage 2009; Springer Wien New York |
| COMPLETED |
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| NOT COMPLETED |
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One among the 30 enrolled participants had both colon and rectum cancer and only information from rectum cancer is given in the baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | All participants (patients with colorectal cancer after adjuvant chemotherapy) included in this single arm study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Cancer location | Count of Participants | Participants |
| ||||||||||||||||||
| pT-Stage | Pathologic T-stage: pT1, tumour only in the inner layer of the bowel; pT2, tumour has grown into the muscle layer of the bowel wall; pT3, tumour has grown into the outer lining of the bowel wall but has not grown through; pTX, not determinable | Count of Participants | Participants |
| |||||||||||||||||
| pN-Stage | Pathologic N-stage: pN0, no lymph nodes containing cancer cells; pN1, cancer cells in 1 to 3 nearby lymph nodes or in the nearby tissue; pN2, cancer cells in 4 or more nearby lymph nodes | Count of Participants | Participants |
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| Chemotherapy | Count of Participants | Participants |
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| Height | Median | Full Range | cm |
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| Weight | Median | Full Range | kg |
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| pM-Stage | Pathologic M-stage (metastases): M0, the cancer has not spread to other organs; MX: not determinable | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Total of all 30 participants enrolled | Posted | Count of Units | Participant-weeks | 3 months | Participant-weeks | Participant-weeks |
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| Primary | 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) | Total of all 30 participants enrolled | Posted | Count of Units | Participant-weeks | 6 months | Participant-weeks | Participant-weeks |
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| Primary | 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) | Total of all 30 participants enrolled | Posted | Count of Units | Participant-weeks | 12 months | Participant-weeks | Participant-weeks |
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| Secondary | 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) | All participants with METs information | Posted | Mean | Standard Deviation | kcal/kg/hour | 3 months |
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| Secondary | 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) | All participants with METs information | Posted | Mean | Standard Deviation | kcal/kg/hour | 6 months |
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| Secondary | 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) | All participants with METs information | Posted | Mean | Standard Deviation | kcal/kg/hour | 12 months |
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| Secondary | Adiponectin at Screening | Evaluation of adiponectin at screening as baseline for a description of changes during the study | All participants with information on adiponectin | Posted | Mean | Standard Deviation | μg/ml | Day 1 (at screening) |
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| Secondary | Adiponectin After 12 Weeks (3 Months) | Evaluation of adiponectin after 12 weeks (3 months) for a description of changes during the study | All participants with information on adiponectin | Posted | Mean | Standard Deviation | μg/ml | 3 months |
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| Secondary | Adiponectin After 52 Weeks (12 Months) | Evaluation of adiponectin after 52 weeks (12 months) for a description of changes during the study | All participants with information on adiponectin | Posted | Mean | Standard Deviation | μg/ml | 12 months |
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| Secondary | Leptin at Screening | Evaluation of leptin at screening as baseline for a description of changes during the study | All participants with information on leptin | Posted | Mean | Standard Deviation | ng/ml | Day 1 (at screening) |
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| Secondary | Leptin After 12 Weeks (3 Months) | Evaluation of leptin after 12 weeks (3 months) for a description of changes during the study | All participants with information on leptin | Posted | Mean | Standard Deviation | ng/ml | 3 months |
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| Secondary | Leptin After 52 Weeks (12 Months) | Evaluation of leptin after 52 weeks (12 months) for a description of changes during the study | All participants with information on leptin | Posted | Mean | Standard Deviation | ng/ml | 12 months |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Exercise | No treatment, only physical examinations accompanying physical exercise (defined exercise program) | 0 | 30 | 0 | 30 | 2 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Heart pain | Cardiac disorders | Non-systematic Assessment |
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| Indisposition | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Office Director | ABCSG (Austrian Breast & Colorectal Cancer Study Group) | +43 1 4089230 | info@abcsg.at |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Colon and rectum |
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| pT3 |
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| pT4 |
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| pTX |
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| pN2 |
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