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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Physical activity

About this trial

This is an interventional other trial for Colorectal Cancer focused on measuring colon, cancer, prevention, exercise, physical activity, rectal

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity

Arm Description

Physical activity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Peak oxygen consumption

Spiroergometry will be used to assess peak oxygen consumption (VO2peak).

Patient satisfaction

Patient satisfaction will be measured using questionnaire.

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).

Anxiety and depression

Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D).

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).

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).

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.

Full Information

NCT ID

NCT01991847

First Posted

November 18, 2013

Last Updated

November 24, 2017

Sponsor

Technical University of Munich

Collaborators

German Cancer Aid

1. Study Identification

Unique Protocol Identification Number

NCT01991847

Brief Title

Tertiary Prevention by Exercise in Colorectal Cancer Therapy

Acronym

F-PROTECT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technical University of Munich

Collaborators

German Cancer Aid

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

colon, cancer, prevention, exercise, physical activity, rectal

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical activity

Arm Type

Experimental

Arm Description

Physical activity

Intervention Type

Behavioral

Intervention Name(s)

Physical activity

Intervention Description

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.

Primary Outcome Measure Information:

Title

Target sample size

Description

The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year.

Time Frame

one year

Secondary Outcome Measure Information:

Title

Physical activity

Description

Time Frame

at screening and 3, 6, 9, and 12 month after baseline

Title

Peak oxygen consumption

Description

Spiroergometry will be used to assess peak oxygen consumption (VO2peak).

Time Frame

at baseline and 12 month after baseline

Title

Patient satisfaction

Description

Patient satisfaction will be measured using questionnaire.

Time Frame

at 3, 6, 9, and 12 month after baseline

Title

Cancer related fatigue

Description

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).

Time Frame

at screening and 6 and 12 month after baseline

Title

Anxiety and depression

Description

Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D).

Time Frame

at screening and 6 and 12 month after baseline

Title

Cancer related quality of life

Description

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).

Time Frame

at screening and 6 and 12 month after baseline

Title

Quality of life in colorectal cancer

Description

Time Frame

at screening and 6 and 12 month after baseline

Title

Adverse and serious adverse events

Description

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.

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Halle, Prof. M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Munich

ZIP/Postal Code

80809

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Tertiary Prevention by Exercise in Colorectal Cancer Therapy

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