Skip to main content
OpenTrials
Completed

NCT Number: NCT01210313

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Carcinoma Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital BHB St. Veit/Glan, Surgery, Saint Veit A. D. Glan, Carinthia, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

Defined exercise program

Primary outcomes

  1. Feasibility of Physical Activity After 12 Weeks (3 Months)

    Time frame: 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)

  2. Feasibility of Physical Activity After 26 Weeks (6 Months)

    Time frame: 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)

  3. Feasibility of Physical Activity After 52 Weeks (12 Months)

    Time frame: 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)

Secondary outcomes

  1. Exercise Ergometry Activity After 12 Weeks (3 Months)

    Time frame: 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)

  2. Exercise Ergometry Activity After 26 Weeks (6 Months)

    Time frame: 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)

  3. Exercise Ergometry Activity After 52 Weeks (12 Months)

    Time frame: 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)

  4. Adiponectin at Screening

    Time frame: Day 1 (at screening)

    Evaluation of adiponectin at screening as baseline for a description of changes during the study

  5. Adiponectin After 12 Weeks (3 Months)

    Time frame: 3 months

    Evaluation of adiponectin after 12 weeks (3 months) for a description of changes during the study

  6. Adiponectin After 52 Weeks (12 Months)

    Time frame: 12 months

    Evaluation of adiponectin after 52 weeks (12 months) for a description of changes during the study

  7. Leptin at Screening

    Time frame: Day 1 (at screening)

    Evaluation of leptin at screening as baseline for a description of changes during the study

  8. Leptin After 12 Weeks (3 Months)

    Time frame: 3 months

    Evaluation of leptin after 12 weeks (3 months) for a description of changes during the study

  9. Leptin After 52 Weeks (12 Months)

    Time frame: 12 months

    Evaluation of leptin after 52 weeks (12 months) for a description of changes during the study

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 28, 2010
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.