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

June 7, 2022 updated by: Austrian Breast & Colorectal Cancer Study Group
  • feasibility of physical activity
  • increase of physical conversation
  • Quality of Life (optional)
  • vascular and metabolic effects

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Paracelsus Medical University Salzburg-Oncology, Coop. Group
    • Carinthia
      • St. Veit a. d. Glan, Carinthia, Austria, 9330
        • Hospital BHB St. Veit/Glan, Surgery
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University Innsbruck, Internal Medicine
      • Kufstein, Tyrol, Austria, 6330
        • District Hospital Kufstein
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • AKH Linz
      • Wels, Upper Austria, Austria, 4600
        • Klinikum Wels-Grieskirchen
    • Vorarlberg
      • Rankweil, Vorarlberg, Austria, 6830
        • State Hospital Rankweil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

subjects with localised colorectal carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of physical activity
Time Frame: after 3 months
evaluation by frequency and duration of training interruptions or training discontinuations
after 3 months
feasibility of physical activity
Time Frame: after 6 months
evaluation by frequency and duration of training interruptions or training discontinuations
after 6 months
feasibility of physical activity
Time Frame: after 12 months
evaluation by frequency and duration of training interruptions or training discontinuations
after 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
increase of physical efficiency
Time Frame: after 3 months
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
after 3 months
increase of physical efficiency
Time Frame: after 6 months
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
after 6 months
increase of physical efficiency
Time Frame: after 12 months
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
after 12 months
Quality of Life scores
Time Frame: study start
optional evaluation by EORTC QLQ-C30 in several trial sites
study start
Quality of Life scores
Time Frame: after 3 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 3 months
Quality of Life scores
Time Frame: after 6 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 6 months
Quality of Life scores
Time Frame: after 9 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 9 months
Quality of Life scores
Time Frame: after 12 months
optional evaluation by EORTC QLQ-C30 in several trial sites
after 12 months
vascular and metabolic effects
Time Frame: study start
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
study start
vascular and metabolic effects
Time Frame: after 3 months
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
after 3 months
vascular and metabolic effects
Time Frame: after 12 months
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
after 12 months
changes of cytokines and adiponectines
Time Frame: study start
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
study start
changes of cytokines and adiponectines
Time Frame: after 3 months
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
after 3 months
changes of cytokines and adiponectines
Time Frame: after 12 months
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
after 12 months
gen- and metabolic signs
Time Frame: study start
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
study start
gen- and metabolic signs
Time Frame: after 3 months
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
after 3 months
gen- and metabolic signs
Time Frame: after 12 months
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Investigators

  • Study Chair: Michael Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group
  • Study Chair: Alfred Fridrik, MD, Austrian Breast & Colorectal Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG C07
  • Exercise (ABCSG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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