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Completed

NCT Number: NCT01991847

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, 80809, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

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.

Primary outcomes

  1. Target sample size

    Time frame: one year

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

Secondary outcomes

  1. Physical activity

    Time frame: at screening and 3, 6, 9, and 12 month after baseline

    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).

  2. Peak oxygen consumption

    Time frame: at baseline and 12 month after baseline

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

  3. Patient satisfaction

    Time frame: at 3, 6, 9, and 12 month after baseline

    Patient satisfaction will be measured using questionnaire.

  4. Cancer related fatigue

    Time frame: at screening and 6 and 12 month after baseline

    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).

  5. Anxiety and depression

    Time frame: at screening and 6 and 12 month after baseline

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

  6. Cancer related quality of life

    Time frame: at screening and 6 and 12 month after baseline

    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).

  7. Quality of life in colorectal cancer

    Time frame: at screening and 6 and 12 month after baseline

    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).

  8. Adverse and serious adverse events

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • German Cancer Aid

Registry information

Official study title

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

Acronym: F-PROTECT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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