Clinical trial NCT01991847: Tertiary Prevention by Exercise in Colorectal Cancer Therapy
Official title: Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon
cancer
prevention
exercise
physical activity
rectal
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
First posted: 2013-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Target sample size
timeFrame: one year
Secondary outcomes:
measure: Physical activity
timeFrame: at screening and 3, 6, 9, and 12 month after baseline
measure: Peak oxygen consumption
timeFrame: at baseline and 12 month after baseline
measure: Patient satisfaction
timeFrame: at 3, 6, 9, and 12 month after baseline
measure: Cancer related fatigue
timeFrame: at screening and 6 and 12 month after baseline
measure: Anxiety and depression
timeFrame: at screening and 6 and 12 month after baseline
measure: Cancer related quality of life
timeFrame: at screening and 6 and 12 month after baseline
measure: Quality of life in colorectal cancer
timeFrame: at screening and 6 and 12 month after baseline
measure: Adverse and serious adverse events
timeFrame: one year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Study officials:
affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
name: Martin Halle, Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
References: