Colorectal CarcinomaABCSG C08NCT03822572
ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer
A study testing endurance exercise in people with Colorectal Carcinoma, run by Austrian Breast & Colorectal Cancer Study Group at 8 sites in Austria.
Trial summary
ABCSG C08 is a randomized, two-arm, multicenter trial to investigate the efficacy of endurance exercise following adjuvant chemotherapy in patients with colorectal cancer. Indication: Locally advanced colorectal cancer after adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- endurance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 8 sitesAustria
- Study dates
- 14 Feb 2019to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely resected, histologically confirmed adenocarcinoma of the colon or rectum
- patients, who have completed adjuvant chemotherapy 4-16 weeks prior to randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age ≥18 years
- adequate hematologic functions <=28d prior to randomization
- able to perform endurance exercise according to protocol
- ability to perform ergometry in order to assess physical capability at the discretion of the investigator
- signed informed consent prior to randomization
Who cannot join
- significant comorbid conditions precluding participation in a physical activity program (investigators decision)
- disabled patients unable to participate in the physical activity program
- Regular (3-times a week) vigorous physical activity of >150 minutes (type of physical activity: bicycling, cross walking (cross trainer), jogging, walking at a brisk pace, nordic walking, cross country skiing) within the last year before diagnosis of colorectal cancer
- patients unwilling to complete endurance exercise or complete all questionnaires related to the study
- past or current history of other malignant neoplasms other than colorectal cancer in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- clinically significant cardiovascular disease
Show all 9Show fewer
- left bundle branch block
- current study with chemotherapy or radiation
- current pregnancy or plans to become pregnant within the next 3 years
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Austria8 sites
KH St. Josef Braunau
Braunau am Inn, Upper Austria, 5280
Med. Univ. Graz
Graz, Styria, 8036
BKH Kufstein
Kufstein, Tyrol, 6330
Hospital BHS Linz, Coop. Study Group
Linz, Upper Austria, 4010
Kepler Universitätsklinikum Linz
Linz, Upper Austria, 4020
LKH Salzburg-PMU, UNiv. KLinik f. Innere Med III
Salzburg, State of Salzburg, 5020
Pyhrn-Eisenwurzen Klinikum Steyr
Steyr, Upper Austria, 4400
Klinikum Wels-Grieskirchen
Wels, Upper Austria, 4600
About this study
Official title: ABCSG C08 - Exercise II: Randomized Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer
ABCSG C08 is a randomized, two-arm, multicenter trial to investigate the efficacy of endurance exercise following adjuvant chemotherapy in patients with colorectal cancer.
Indication: Locally advanced colorectal cancer after adjuvant chemotherapy. Evidence supporting the beneficial effects of exercise programs during chemotherapy are available, the results across studies are not entirely consistent. Additional studies are needed to determine the optimal content, intensity, and form of training programs.
Read the detailed description
Colorectal cancer is the second leading cause of cancer mortality in Western countries after breast cancer among women and lung cancer among men. About 5.000 new cases are diagnosed each year in Austria. This represents an annual incidence of 50-60 per 100.000 inhabitants. In patients with colorectal cancer stage III and in certain situations even in stage II adjuvant chemotherapy is indicated after R0 resection. Despite recent advances in adjuvant chemotherapy 20-30% of these patients still relapse. About 80% of recurrences occur in the first three years.
There is consistent evidence from several observational epidemiologic studies that physical activity reduces the risk of developing colon cancer. In recent years several observational studies even showed a reduction in relapse rate, colon cancer-specific mortality and overall mortality by physical activity in patients with colon and breast cancer. Colon cancer survivors who engaged in higher levels of physical activity experienced a 50-60% improvement in long-term outcomes compared to inactive patients. Different mechanisms for the protective effect of physical activity on colon cancer have been proposed and it is believed that the same mechanisms of physical activity are also involved in the improvement of disease outcomes in gastrointestinal cancer survivors. Physical activity leads to decrease of inflammation, decreased levels of insulin-like growth factor (IGF) and insulin, reduced transit time through the gut and increased levels of vitamin D. Factors, that are associated with a reduced risk of colon polyps, colon cancer and colon cancer mortality.
A review on the impact of various exercise programs on fatigue, found good evidence that exercise not only decreased levels of fatigue, but also increased quality of life, mood and functioning.
While there is evidence supporting the beneficial effects of exercise programs during chemotherapy, the results across studies are not entirely consistent. Additional studies are needed to determine the optimal content, intensity, and form of training programs.
Recently ABCSG has investigated the feasibility of endurance exercise after adjuvant chemotherapy in patients with locally advanced colorectal cancer in the investigator's study group (ABCSG C07 Exercise - pilot study). Results concerning compliance of patients have been considered for sample size estimations and study planning.
- Conditions
- Colorectal Carcinoma
- Being tested
- endurance exercise, control
- Keywords
- endurance exercise
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endurance exerciseOther
defined exercise program
controlOther
habitual physical activity before the diagnosis
| Study group | Role | What they receive |
|---|---|---|
| A - endurance exercise | Experimental | All patients receive a pulse-controlled endurance exercise program based on the study results by O'Donovan. The individual pulse-controlled endurance exercise should be performed 3 times a week. On the basis of age, weight, sex and body fat the normal weight will be calculated. The kilocalories (kcal), which correspond to the metabolic equivalent task (MET) hour per week, will be calculated after age and gender adjustment of the normal weight. The endurance exercise will be increased gradually until reaching 18 MET-hours/wk during the year of endurance exercise. Patients in arm A can perform different types of endurance exercise (bicycling, cross walking, jogging, walking, nordic walking, cross country skiing) Receives: Other: endurance exercise |
| B - control arm | Other | Patients in this arm should maintain their habitual physical activity pattern as before the diagnoses of colorectal cancer. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint - disease free survival (DFS)
DFS is defined as the time from randomization to locoregional or metastatic recurrence or the appearance of secondary cancer or death, whichever occurs first. Recurrence may be either histologically proven or evidenced by imaging via MRI or CT. Isolated CEA evaluation will not be sufficient to determine a relapse.
Measured: 8 years (after Last Patient Out (LPO))
Secondary outcomes (18)
Secondary Efficacy Endpoint I - relapse free survival (RFS)
RFS is defined as the time from randomization to locoregional or metastatic recurrence of colorectal cancer or death, whichever occurs first
Measured: 8 years (after Last Patient Out (LPO))
Secondary Efficacy Endpoint II - overall survival (OS)
OS is defined as time from randomization to death from any cause
Measured: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint I - physical activity measured by MET-hours
Evaluation of physical activities measured by MET-hours in the domains "work", "leisure time ", "sedentary behavior" and "transporation" by Global Physical Activity Questionnaire (GPAQ) within each study arm and compared between study arms at baseline, at 3, at 6, at 12, at 24 and at 36 months
Measured: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint II - endurance exercise measured by MET-hours
Evaluation of endurance exercise measured by MET-hours by pulse-control in arm A at 3, at 6 and at 12 months
Measured: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint III - performance enhancement measured by MET-hours by ergometry
Evaluation of performance enhancement measured by MET-hours by ergometry within each study arm (arm A at baseline, at 3, at 6 and at 12 months; arm B at baseline and at 12 months) and compared between study arms at baseline and at 12 months
Measured: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint IV - physical activity measures
Correlation of MET-hours in the domains "work", "leisure time ", "sedentary behavior" and "transporation" by Global Physical Activity Questionnaire (GPAQ) and results of endurance exercise as well as performance enhancement by ergometry (both measured by MET-hours) with DFS, RFS and OS
Measured: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint I - fatigue
Evaluation of fatigue as measured by EORTC - QLQ FATIGUE CAT Theta scores compared between study arms. Score has no fixed upper and lower limit and a high score represents a high level of fatigue.
Measured: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint II - emotional functioning score
Evaluation of the emotional functioning score (based in the functional scale EF) as measured by EORTC QLQ-C30 emotional functioning (based on items) compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning.
Measured: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint III - physical functioning score
Evaluation of the standardized physical functioning score (based on the revised functional scale PF2) as measured by EORTC QLQ-C30 physical functioning compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning
Measured: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint IV - global quality of life (QoL) score
Evaluation of the standardized global health status/QoL score (based on the revised global health status/QoL QL2) as measured by EORTC QLQ-C30 summary score compared between study arms, where a high score for the global health status/QoL represents a high QoL.
Measured: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint V - patient reported outcomes (fatigue, emotional functioning, physical functioning, global quality of life)
Correlation of all patient reported outcomes explained above (fatigue, emotional functioning, physical functioning, global quality of life) with MET-hours
Measured: 8 years (after Last Patient Out (LPO))
Body Composition Endpoint I - body mass index (BMI)
Evaluation of the influence of BMI on DFS, RFS and OS
Measured: 8 years (after Last Patient Out (LPO))
Body Composition Endpoint II - body fat
Evaluation of the influence of body fat on DFS, RFS and OS
Measured: 8 years (after Last Patient Out (LPO))
Body Composition Endpoint III - waist circumference
Evaluation of the influence of waist circumference on DFS, RFS and OS
Measured: 8 years (after Last Patient Out (LPO))
Cardiovascular Endpoint - cardiovascular complications
Evaluation of the incidence of cardiovascular complications (myocardial infarction, stroke, newly diagnosed diabetes mellitus, newly diagnosed hypertension)
Measured: 8 years (after Last Patient Out (LPO))
Safety Endpoint I - serious adverse events (SAEs)
Evaluation of the incidence of physical activity related SAEs and physical activity related deaths in both arms
Measured: 8 years (after Last Patient Out (LPO))
Safety Endpoint II - time to SAEs
Evaluation of time from study start to physical activity related SAEs
Measured: 8 years (after Last Patient Out (LPO))
Exploratory Endpoint - molecular and biochemical markers (will be defined during the course of the study)
Correlation of molecular and biochemical markers with DFS, RFS, OS and with physical activity. The analysis of molecular markers will depend on the markers which will be defined during the course of the study in addition to Insulin \& ILGF.
Measured: 8 years (after Last Patient Out (LPO))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start14 Feb 2019
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Collaborators
- Oberösterreichische Krebshilfe
- Responsible party
- Sponsor
- Investigators
- Gudrun Piringer, MD, MSc, Study chair, Austrian Breast & Colorectal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822572
- Sponsor's protocol ID
- ABCSG C08
- Acronym
- ABCSG C08
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2018
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: currently sharing of IPDs (Individual Participant Data) is not planned in this trial
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABCSG C08 - Exercise II: Randomized Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03822572
- Acronym / sponsor ID
- ABCSG C08 / ABCSG C08
- Conditions
- Colorectal Carcinoma
- Keywords
- endurance exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Collaborators
- Oberösterreichische Krebshilfe
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ABCSG C08 is a randomized, two-arm, multicenter trial to investigate the efficacy of endurance exercise following adjuvant chemotherapy in patients with colorectal cancer.
Indication: Locally advanced colorectal cancer after adjuvant chemotherapy. Evidence supporting the beneficial effects of exercise programs during chemotherapy are available, the results across studies are not entirely consistent. Additional studies are needed to determine the optimal content, intensity, and form of training programs.
Detailed description
Colorectal cancer is the second leading cause of cancer mortality in Western countries after breast cancer among women and lung cancer among men. About 5.000 new cases are diagnosed each year in Austria. This represents an annual incidence of 50-60 per 100.000 inhabitants. In patients with colorectal cancer stage III and in certain situations even in stage II adjuvant chemotherapy is indicated after R0 resection. Despite recent advances in adjuvant chemotherapy 20-30% of these patients still relapse. About 80% of recurrences occur in the first three years.
There is consistent evidence from several observational epidemiologic studies that physical activity reduces the risk of developing colon cancer. In recent years several observational studies even showed a reduction in relapse rate, colon cancer-specific mortality and overall mortality by physical activity in patients with colon and breast cancer. Colon cancer survivors who engaged in higher levels of physical activity experienced a 50-60% improvement in long-term outcomes compared to inactive patients. Different mechanisms for the protective effect of physical activity on colon cancer have been proposed and it is believed that the same mechanisms of physical activity are also involved in the improvement of disease outcomes in gastrointestinal cancer survivors. Physical activity leads to decrease of inflammation, decreased levels of insulin-like growth factor (IGF) and insulin, reduced transit time through the gut and increased levels of vitamin D. Factors, that are associated with a reduced risk of colon polyps, colon cancer and colon cancer mortality.
A review on the impact of various exercise programs on fatigue, found good evidence that exercise not only decreased levels of fatigue, but also increased quality of life, mood and functioning.
While there is evidence supporting the beneficial effects of exercise programs during chemotherapy, the results across studies are not entirely consistent. Additional studies are needed to determine the optimal content, intensity, and form of training programs.
Recently ABCSG has investigated the feasibility of endurance exercise after adjuvant chemotherapy in patients with locally advanced colorectal cancer in the investigator's study group (ABCSG C07 Exercise - pilot study). Results concerning compliance of patients have been considered for sample size estimations and study planning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - endurance exercise | Experimental | Other: endurance exerciseAll patients receive a pulse-controlled endurance exercise program based on the study results by O'Donovan. The individual pulse-controlled endurance exercise should be performed 3 times a week. On the basis of age, weight, sex and body fat the normal weight will be calculated. The kilocalories (kcal), which correspond to the metabolic equivalent task (MET) hour per week, will be calculated after age and gender adjustment of the normal weight. The endurance exercise will be increased gradually until reaching 18 MET-hours/wk during the year of endurance exercise. Patients in arm A can perform different types of endurance exercise (bicycling, cross walking, jogging, walking, nordic walking, cross country skiing) |
| B - control arm | Other | Other: controlPatients in this arm should maintain their habitual physical activity pattern as before the diagnoses of colorectal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- completely resected, histologically confirmed adenocarcinoma of the colon or rectum
- patients, who have completed adjuvant chemotherapy 4-16 weeks prior to randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age ≥18 years
- adequate hematologic functions <=28d prior to randomization
Key exclusion criteria (9 listed)
- significant comorbid conditions precluding participation in a physical activity program (investigators decision)
- disabled patients unable to participate in the physical activity program
- Regular (3-times a week) vigorous physical activity of >150 minutes (type of physical activity: bicycling, cross walking (cross trainer), jogging, walking at a brisk pace, nordic walking, cross country skiing) within the last year before diagnosis of colorectal cancer
- patients unwilling to complete endurance exercise or complete all questionnaires related to the study
- past or current history of other malignant neoplasms other than colorectal cancer in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endurance exercisedefined exercise program | Other | A - endurance exercise |
| controlhabitual physical activity before the diagnosis | Other | B - control arm |
Primary outcome
Primary Endpoint - disease free survival (DFS)
Time frame: 8 years (after Last Patient Out (LPO))
DFS is defined as the time from randomization to locoregional or metastatic recurrence or the appearance of secondary cancer or death, whichever occurs first. Recurrence may be either histologically proven or evidenced by imaging via MRI or CT. Isolated CEA evaluation will not be sufficient to determine a relapse.
18 secondary outcomes
Secondary Efficacy Endpoint I - relapse free survival (RFS)
Time frame: 8 years (after Last Patient Out (LPO))
Secondary Efficacy Endpoint II - overall survival (OS)
Time frame: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint I - physical activity measured by MET-hours
Time frame: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint II - endurance exercise measured by MET-hours
Time frame: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint III - performance enhancement measured by MET-hours by ergometry
Time frame: 8 years (after Last Patient Out (LPO))
Physical Activity Endpoint IV - physical activity measures
Time frame: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint I - fatigue
Time frame: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint II - emotional functioning score
Time frame: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint III - physical functioning score
Time frame: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint IV - global quality of life (QoL) score
Time frame: 8 years (after Last Patient Out (LPO))
Patient Reported Outcome Endpoint V - patient reported outcomes (fatigue, emotional functioning, physical functioning, global quality of life)
Time frame: 8 years (after Last Patient Out (LPO))
Body Composition Endpoint I - body mass index (BMI)
Time frame: 8 years (after Last Patient Out (LPO))
Body Composition Endpoint II - body fat
Time frame: 8 years (after Last Patient Out (LPO))
Body Composition Endpoint III - waist circumference
Time frame: 8 years (after Last Patient Out (LPO))
Cardiovascular Endpoint - cardiovascular complications
Time frame: 8 years (after Last Patient Out (LPO))
Safety Endpoint I - serious adverse events (SAEs)
Time frame: 8 years (after Last Patient Out (LPO))
Safety Endpoint II - time to SAEs
Time frame: 8 years (after Last Patient Out (LPO))
Exploratory Endpoint - molecular and biochemical markers (will be defined during the course of the study)
Time frame: 8 years (after Last Patient Out (LPO))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. currently sharing of IPDs (Individual Participant Data) is not planned in this trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gudrun Piringer, MD, MSc study chair
Austrian Breast & Colorectal Cancer Study Group
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endurance exercise in people with Colorectal Carcinoma, run by Austrian Breast & Colorectal Cancer Study Group at 8 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint - disease free survival (DFS) (time frame: 8 years (after Last Patient Out (LPO))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.