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

Austrian Breast & Colorectal Cancer Study Group30 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Carcinoma

Interventions

Physical exerciseOTHER

Defined exercise program

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, Austria

Medical University Innsbruck, Internal Medicine

Innsbruck, Tyrol, Austria

District Hospital Kufstein

Kufstein, Tyrol, Austria

AKH Linz

Linz, Upper Austria, Austria

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 12 months

Secondary Outcomes

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)

Time frame: 3 months

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)

Time frame: 6 months

Exercise Ergometry Activity After 52 Weeks (12 Months)

Data from ClinicalTrials.gov

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