NCT02250053

Brief Summary

Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

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

September 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2016

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

September 22, 2014

Last Update Submit

April 7, 2020

Conditions

Stage II Colon CancerStage III Colon Cancer

Keywords

stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer

Outcome Measures

Primary Outcomes (1)

  • 1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.

    2 years

Secondary Outcomes (4)

  • Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;

    6 months

  • Visceral adipose tissue and anthropometric measures at baseline and six-months;

    6 months

  • Fasting insulin measured at baseline and six-months;

    six months

  • Circulating tumor cells measured at baseline and six-months.

    six months

Study Arms (1)

exercise

EXPERIMENTAL

aerobic exercise on soluble intercellular adhesion molecules

Other: Exercise

Interventions

ExerciseOTHER
exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed TNM stage II-III CC;
  • completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
  • ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
  • age ≥18 years;
  • written physician approval;
  • no additional surgery planned within the 6-month intervention (including colostomy reversal);
  • ability to walk unaided for 6-minutes;
  • no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.

You may not qualify if:

  • history of another primary invasive cancer (other than non-melanoma skin-cancer);
  • evidence of metastatic CC (i.e., TNM M1);
  • planning to receive any additional adjuvant chemotherapy;
  • pregnant or breast feeding;
  • unable to provide baseline blood sample;
  • cardiac conditions, including the following:
  • myocardial infarction or coronary revascularization procedure within prior 3 months;
  • uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
  • high-risk or uncontrolled arrhythmias;
  • clinically significant valvular disease;
  • decompensated heart failure;
  • known aortic aneurysm;
  • any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Brown JC, Compton SLE, Meyerhardt JA, Spielmann G, Yang S. The dose-response effect of aerobic exercise on inflammation in colon cancer survivors. Front Oncol. 2023 Dec 12;13:1257767. doi: 10.3389/fonc.2023.1257767. eCollection 2023.

    PMID: 38148846DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kathryn Schmitz, PhD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: exercise
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 26, 2014

Study Start

December 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 15, 2016

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

US(1)