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

Austrian Breast & Colorectal Cancer Study Group

Status: Enrolling

Conditions: Colorectal Carcinoma

Treatments: Other: endurance exercise; Other: control

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT03822572

ABCSG C08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 788 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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788 participants in 2 patient groups

A - endurance exercise

Experimental group

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)

Treatment:

Other: endurance exercise

B - control arm

Other group

Description:

Patients in this arm should maintain their habitual physical activity pattern as before the diagnoses of colorectal cancer.

Treatment:

Other: control