Exercise and Colon Cancer

NCT ID: NCT02250053

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Stage II Colon Cancer Stage III Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

exercise
Primary Study Purpose

TREATMENT

Study Groups

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exercise

aerobic exercise on soluble intercellular adhesion molecules

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Interventions

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Exercise

Intervention Type OTHER

Eligibility Criteria

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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

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38148846 (View on PubMed)

Other Identifiers

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UPCC 10214

Identifier Type: -

Identifier Source: org_study_id

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