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

NCT01210313 | Completed Results

• 2 other identifiers: ABCSG C07EXERCISE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Colorectal Carcinoma

Keywords

physical activity

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• Exercise Ergometry Activity After 12 Weeks (3 Months)

  3 months

• Exercise Ergometry Activity After 26 Weeks (6 Months)

  6 months

• Exercise Ergometry Activity After 52 Weeks (12 Months)

  12 months

• Adiponectin at Screening

  Day 1 (at screening)

• Adiponectin After 12 Weeks (3 Months)

  3 months

Study Arms (1)

Physical exercise

No treatment, only physical examinations accompanying physical exercise

Other: Physical exercise

Interventions

Physical exercise OTHER

Defined exercise program

Physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

subjects with localised colorectal carcinoma

You may qualify if:

• 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
• weeks after the end of an adjuvant chemotherapy
• ECOG 0,1
• Age \> 18 years
• adequate liver-, nephro- and hemogram parameters
• physical eligibility

You may not qualify if:

• 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

Sponsors & Collaborators

• Austrian Breast & Colorectal Cancer Study Group: lead

Study Sites (7)

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, 9330, Austria

Location

Medical University Innsbruck, Internal Medicine

Innsbruck, Tyrol, 6020, Austria

Location

District Hospital Kufstein

Kufstein, Tyrol, 6330, Austria

Location

AKH Linz

Linz, Upper Austria, 4020, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

State Hospital Rankweil

Rankweil, Vorarlberg, 6830, Austria

Location

Paracelsus Medical University Salzburg-Oncology, Coop. Group

Salzburg, 5020, Austria

Location

Related Publications (8)

• 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.

  PMID: 16822844 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.

  PMID: 16822843 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.

  PMID: 15914748 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.

  PMID: 16822842 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.

  PMID: 718832 RESULT

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

  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.

  PMID: 15640382 RESULT

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

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Trial Office Director
• Organization: ABCSG (Austrian Breast & Colorectal Cancer Study Group)

info@abcsg.at

+43 1 4089230

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 28, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Locations

AU (7)