Colorectal CancerF-PROTECTNCT01991847
Tertiary Prevention by Exercise in Colorectal Cancer Therapy
A study testing Physical activity in people with Colorectal Cancer, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- hereditary colon cancer diagnosis
- R1 and R2 resection
- clinically relevant complications during recovery
- secondary neoplasm
- non-continuance of guideline conformed therapy
- uncontrolled infection
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Munich, 80809
About this study
Official title: 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.
Read the 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
- Being tested
- Physical activity
- Keywords
- colon, cancer, prevention, exercise, physical activity, rectal
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Physical activity Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (8)
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).
Measured: at screening and 3, 6, 9, and 12 month after baseline
Peak oxygen consumption
Spiroergometry will be used to assess peak oxygen consumption (VO2peak).
Measured: at baseline and 12 month after baseline
Patient satisfaction
Patient satisfaction will be measured using questionnaire.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid
- Responsible party
- Sponsor
- Investigators
- Martin Halle, Prof. M.D., Principal investigator, Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991847
- Sponsor's protocol ID
- F-PROTECT
- Acronym
- F-PROTECT
- Status last verified
- Nov 2017
- First submitted
- 18 Nov 2013
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38654917
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)
- ClinicalTrials.gov ID
- NCT01991847
- Acronym / sponsor ID
- F-PROTECT / F-PROTECT
- Conditions
- Colorectal Cancer
- Keywords
- colon, cancer, prevention, exercise, physical activity, rectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Cancer Aid
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityPhysical activity |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- hereditary colon cancer diagnosis
- R1 and R2 resection
- clinically relevant complications during recovery
- secondary neoplasm
- non-continuance of guideline conformed therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThe 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. | Behavioural | Physical activity |
Primary outcome
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.
8 secondary outcomes
Physical activity
Time frame: at screening and 3, 6, 9, and 12 month after baseline
Peak oxygen consumption
Time frame: at baseline and 12 month after baseline
Patient satisfaction
Time frame: at 3, 6, 9, and 12 month after baseline
Cancer related fatigue
Time frame: at screening and 6 and 12 month after baseline
Anxiety and depression
Time frame: at screening and 6 and 12 month after baseline
Cancer related quality of life
Time frame: at screening and 6 and 12 month after baseline
Quality of life in colorectal cancer
Time frame: at screening and 6 and 12 month after baseline
Adverse and serious adverse events
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Derived from this study: PubMed 38654917Heitkamp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Halle, Prof. M.D. principal investigator
Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Colorectal Cancer, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target sample size (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.