Clinical trial NCT01210313: Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
Official title: Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Carcinoma
Keywords: physical activity
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
First posted: 2010-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects with localised colorectal carcinoma

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Physical Activity After 12 Weeks (3 Months)
timeFrame: 3 months
measure: Feasibility of Physical Activity After 26 Weeks (6 Months)
timeFrame: 6 months
measure: Feasibility of Physical Activity After 52 Weeks (12 Months)
timeFrame: 12 months
Secondary outcomes:
measure: Exercise Ergometry Activity After 12 Weeks (3 Months)
timeFrame: 3 months
measure: Exercise Ergometry Activity After 26 Weeks (6 Months)
timeFrame: 6 months
measure: Exercise Ergometry Activity After 52 Weeks (12 Months)
timeFrame: 12 months
measure: Adiponectin at Screening
timeFrame: Day 1 (at screening)
measure: Adiponectin After 12 Weeks (3 Months)
timeFrame: 3 months
measure: Adiponectin After 52 Weeks (12 Months)
timeFrame: 12 months
measure: Leptin at Screening
timeFrame: Day 1 (at screening)
measure: Leptin After 12 Weeks (3 Months)
timeFrame: 3 months
measure: Leptin After 52 Weeks (12 Months)
timeFrame: 12 months
Other outcomes:
Locations:
city: St. Veit a. d. Glan
country: Austria
facility: Hospital BHB St. Veit/Glan, Surgery
state: Carinthia
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, Internal Medicine
state: Tyrol
city: Kufstein
country: Austria
facility: District Hospital Kufstein
state: Tyrol
city: Linz
country: Austria
facility: AKH Linz
state: Upper Austria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
state: Upper Austria
city: Rankweil
country: Austria
facility: State Hospital Rankweil
state: Vorarlberg
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg-Oncology, Coop. Group
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Josef Thaler, MD
role: STUDY_CHAIR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Michael Fridrik, MD
role: STUDY_CHAIR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Alfred Fridrik, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hoeger W, Hoeger S. Principles and Labs for Physical Fitness. Morton Publishing Company, first edition 1999
citation: 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.
citation: Haber Paul. Leitfaden zur medizinischen Trainingsberatung - Rehabilitation bis Leistungssport. 3. Auflage 2009; Springer Wien New York