ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer (ABCSG C08)

  • STATUS
    Recruiting
  • End date
    Dec 6, 2026
  • participants needed
    788
  • sponsor
    Austrian Breast & Colorectal Cancer Study Group
Updated on 6 June 2022
adenocarcinoma
adjuvant chemotherapy
adenocarcinoma of colon

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. 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.

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.

Details
Condition Colorectal Carcinoma
Treatment Control, Endurance exercise
Clinical Study IdentifierNCT03822572
SponsorAustrian Breast & Colorectal Cancer Study Group
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

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
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