Status:
ACTIVE_NOT_RECRUITING
ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
Oberösterreichische Krebshilfe
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 advance...
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 Austr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03822572
Start Date
February 14 2019
End Date
January 1 2028
Last Update
September 10 2025
Active Locations (8)
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1
LKH Salzburg-PMU, UNiv. KLinik f. Innere Med III
Salzburg, Salzburg, Austria, 5020
2
Med. Univ. Graz
Graz, Styria, Austria, 8036
3
BKH Kufstein
Kufstein, Tyrol, Austria, 6330
4
KH St. Josef Braunau
Braunau am Inn, Upper Austria, Austria, 5280