Tertiary Prevention by Exercise in Colorectal Cancer Therapy

NCT ID: NCT01991847

Last Updated: 2017-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-04-30

Brief Summary

The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.

Detailed Description

Apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer. Furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer. However, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients. The long-term aim of this study is to evaluate whether physical activity of ≥ 18 MET-h (Metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage UICC II/III). In the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (F-PROTECT). Essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.

Conditions

Colorectal Cancer

Keywords

colon; cancer; prevention; exercise; physical activity; rectal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Physical activity

Physical activity

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

The patients will perform increasing volumes of moderate intensity endurance (e.g. walking, cycling) exercise, leading up to 18 MET-hours per week by the end of three months. Patients will then maintain this activity level for the remaining 9 months, with reduced supervision.

Interventions

Physical activity

The patients will perform increasing volumes of moderate intensity endurance (e.g. walking, cycling) exercise, leading up to 18 MET-hours per week by the end of three months. Patients will then maintain this activity level for the remaining 9 months, with reduced supervision.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• histologically confirmed nonhereditary primary Stage II or III colon cancer diagnosis or rectal cancer
• written informed consent in German
• histopathologically confirmed R0-resection
• start of guideline conformed adjuvant chemotherapy within 12 weeks after R0-resection in Stage III colon cancer diagnosis (if necessary in Stage III colon cancer diagnosis)

Exclusion Criteria

• hereditary colon cancer diagnosis
• R1 and R2 resection
• clinically relevant complications during recovery
• secondary neoplasm
• non-continuance of guideline conformed therapy
• uncontrolled infection
• manifest cardiac disease (e.g. unstable CAD, heart failure (NYHA IV), malignant hypertension)
• clinical relevant respiratory disease (GOLD IV)
• musculoskeletal disorders severely restricting the patients mobility (e.g. gonarthrosis, coxarthrosis)
• cirrhosis of the liver (Child B and C)
• Karnofsky performance status scale ≤ 60%
• maximal exercise capacity ≤ 50 watt
• clinically relevant lab factors (leukocyte count ≤ 3000/μl, thrombocyte count ≤ 20.000/μl, hemoglobin < 8 g/dl)
• physical activity level ≥ 18 MET-h/ week at screening

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Aid

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Halle, Prof. M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich

Locations

Department of Medicine, Division of Prevention and Sports Medicine TU Munich

Munich, , Germany

Countries

Germany

References

Heitkamp M, Spanier B, von Korn P, Knapp S, Gross C, Haller B, Halle M. Feasibility of a 12-Month Exercise Intervention in Postsurgical Colorectal Cancer Patients. Transl Sports Med. 2023 Jan 20;2023:4488334. doi: 10.1155/2023/4488334. eCollection 2023.

Reference Type: DERIVED

PMID: 38654917 (View on PubMed)

Other Identifiers

F-PROTECT

Identifier Type: -

Identifier Source: org_study_id