Tertiary Prevention by Exercise in Colorectal Cancer Therapy

Colorectal Cancer Clinical Trial

— F-PROTECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991847
• Other study ID #: F-PROTECT
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: November 24, 2017
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2017
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Medicine, Division of Prevention and Sports Medicine TU Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	German Cancer Aid

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Peak oxygen consumption	Spiroergometry will be used to assess peak oxygen consumption (VO2peak).	at baseline and 12 month after baseline
Secondary	Patient satisfaction	Patient satisfaction will be measured using questionnaire.	at 3, 6, 9, and 12 month after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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