Clinical trial · Interventional
Tertiary Prevention by Exercise in Colorectal Cancer Therapy
Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)
NCT01991847CI-TRIAL-00030535F-PROTECTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Physical activity
- description
- Physical activity
- interventionNames
- Behavioral: Physical activity
Primary outcomes (1)
- measure
- Target sample size
- timeFrame
- one year
- description
- 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 (8)
- measure
- Physical activity
- timeFrame
- at screening and 3, 6, 9, and 12 month after baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHeitkamp 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. PMID 38654917