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CompletedNCT02250053Updated Apr 9, 2020

Exercise and Colon Cancer

An interventional study of Exercise in Stage II Colon Cancer and Stage III Colon Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-09.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Stage II Colon Cancer
  • Stage III Colon Cancer

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Keywords

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

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 44 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. histologically confirmed TNM stage II-III CC;
  2. completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
  3. ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
  4. age ≥18 years;
  5. written physician approval;
  6. no additional surgery planned within the 6-month intervention (including colostomy reversal);
  7. ability to walk unaided for 6-minutes;
  8. no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.

Exclusion criteria

Exclusion Criteria:

  1. history of another primary invasive cancer (other than non-melanoma skin-cancer);
  2. evidence of metastatic CC (i.e., TNM M1);
  3. planning to receive any additional adjuvant chemotherapy;
  4. pregnant or breast feeding;
  5. unable to provide baseline blood sample;

  6. cardiac conditions, including the following:

    1. myocardial infarction or coronary revascularization procedure within prior 3 months;
    2. uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
    3. high-risk or uncontrolled arrhythmias;
    4. clinically significant valvular disease;
    5. decompensated heart failure;
    6. known aortic aneurysm;
  7. 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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrollment
44 participants (actual)

Study arms

  • Experimental
    exercise

    aerobic exercise on soluble intercellular adhesion molecules

    Other: Exercise

Interventions

  • OtherExercise
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What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

  3. Fasting insulin measured at baseline and six-months;

    Time frame: six months

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

    Time frame: six months

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Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02250053
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Sep 26, 2014
Start date
Dec 2015
Primary completion
Jan 2016
Completion
Jan 15, 2016
Last update
Apr 9, 2020

Study contacts

Kathryn Schmitz, PhD
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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