Tertiary Prevention by Exercise in Colorectal Cancer Therapy (F-PROTECT)

Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80809
    • Department of Medicine, Division of Prevention and Sports Medicine TU Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target sample size	The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Physical activity will be measured using physical activity diary, heart rate monitor (Sigma Sport PC 22.13), accelerometer (Aipermotion 440), and the German version of the International Physical Activity Questionnaire (IPAQ).	at screening and 3, 6, 9, and 12 month after baseline
Peak oxygen consumption	Spiroergometry will be used to assess peak oxygen consumption (VO2peak).	at baseline and 12 month after baseline
Patient satisfaction	Patient satisfaction will be measured using questionnaire.	at 3, 6, 9, and 12 month after baseline
Cancer related fatigue	Fatigue will be measured using the German version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-FA13; reduced version with 13 items).	at screening and 6 and 12 month after baseline
Anxiety and depression	Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D).	at screening and 6 and 12 month after baseline
Cancer related quality of life	Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30).	at screening and 6 and 12 month after baseline
Quality of life in colorectal cancer	Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire in colorectal cancer (EORTC QLQ-CR29).	at screening and 6 and 12 month after baseline
Adverse and serious adverse events	Adverse (e.g. dizziness, high blood pressure) and serious adverse events (e.g. death, prolonged hospitalization) will be reported within 24 hours to the study physician via form.	one year

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: German Cancer Aid
• Investigators: Principal Investigator: Martin Halle, Prof. M.D., Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 24, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: physical activity; exercise; cancer; prevention; colon; rectal
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: F-PROTECT