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

NCT03822572 | Active Not Recruiting

• 1 other identifier: ABCSG C08
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 8

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 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

Colorectal Carcinoma

Keywords

endurance exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  8 years (after Last Patient Out (LPO))

Secondary Outcomes (18)

• Secondary Efficacy Endpoint I - relapse free survival (RFS)

  8 years (after Last Patient Out (LPO))

• Secondary Efficacy Endpoint II - overall survival (OS)

  8 years (after Last Patient Out (LPO))

• Physical Activity Endpoint I - physical activity measured by MET-hours

  8 years (after Last Patient Out (LPO))

• Physical Activity Endpoint II - endurance exercise measured by MET-hours

  8 years (after Last Patient Out (LPO))

• Physical Activity Endpoint III - performance enhancement measured by MET-hours by ergometry

  8 years (after Last Patient Out (LPO))

Study Arms (2)

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)

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.

Other: control

Interventions

endurance exercise OTHER

defined exercise program

A - endurance exercise

control OTHER

habitual physical activity before the diagnosis

B - control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Austrian Breast & Colorectal Cancer Study Group: lead
• Oberösterreichische Krebshilfe: collaborator

Study Sites (8)

LKH Salzburg-PMU, UNiv. KLinik f. Innere Med III

Salzburg, Salzburg, 5020, Austria

Location

Med. Univ. Graz

Graz, Styria, 8036, Austria

Location

BKH Kufstein

Kufstein, Tyrol, 6330, Austria

Location

KH St. Josef Braunau

Braunau am Inn, Upper Austria, 5280, Austria

Location

Hospital BHS Linz, Coop. Study Group

Linz, Upper Austria, 4010, Austria

Location

Kepler Universitätsklinikum Linz

Linz, Upper Austria, 4020, Austria

Location

Pyhrn-Eisenwurzen Klinikum Steyr

Steyr, Upper Austria, 4400, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Gudrun Piringer, MD, MSc

  Austrian Breast & Colorectal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: January 30, 2019
• Study Start: February 14, 2019
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8)