Clinical trial · Interventional
ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer
ABCSG C08 - Exercise II: Randomized Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| control | Other | — | UNRESOLVED |
| endurance exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A - endurance exercise
- description
- 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)
- interventionNames
- Other: endurance exercise
- type
- OTHER
- label
- B - control arm
- description
- Patients in this arm should maintain their habitual physical activity pattern as before the diagnoses of colorectal cancer.
- interventionNames
- Other: control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * left bundle branch block * current study with chemotherapy or radiation * current pregnancy or plans to become pregnant within the next 3 years
References
Publications (0)
Data not yet available