NCT01991847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

November 18, 2013

Last Update Submit

November 24, 2017

Conditions

Colorectal Cancer

Keywords

coloncancerpreventionexercisephysical activityrectal

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (8)

  • Physical activity

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

  • Peak oxygen consumption

    at baseline and 12 month after baseline

  • Patient satisfaction

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

  • Cancer related fatigue

    at screening and 6 and 12 month after baseline

  • Anxiety and depression

    at screening and 6 and 12 month after baseline

  • +3 more secondary outcomes

Study Arms (1)

Physical activity

EXPERIMENTAL

Physical activity

Behavioral: Physical activity

Interventions

Physical activityBEHAVIORAL

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.

Physical activity

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, 80809, Germany

Location

Related Publications (1)

  • 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.

    PMID: 38654917DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martin Halle, Prof. M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 28, 2017

Record last verified: 2017-11

Locations

DE(1)