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Trial record 3 of 1758 for:    gastrointestinal | Recruiting, Not yet recruiting, Available Studies | United States

Physical Activity In Gastrointestinal Cancer

This study is not yet open for participant recruitment.
Verified November 2017 by Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03331406
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
  Purpose
This research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program.

Condition Intervention
Metastatic Gastrointestinal Cancer Physical Activity Other: Physical Activity Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer

Resource links provided by NLM:


Further study details as provided by Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Rate of Accrual [ Time Frame: 12 months ]
    Recruit 20 patients within 12 months

  • Number of participants that adhered to physical activity program [ Time Frame: 12 Weeks ]
    Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program.


Secondary Outcome Measures:
  • Rate of Retention [ Time Frame: 12 Weeks ]
    Proportion of participants who complete the study

  • Number of participants that complete assessment procedures [ Time Frame: 12 Weeks ]
    Physical function testing and questionnaire collection

  • Number of participants with adverse events [ Time Frame: 12 Weeks ]
    Falls, hospitalizations, and musculoskeletal injury


Estimated Enrollment: 20
Anticipated Study Start Date: January 15, 2018
Estimated Study Completion Date: January 15, 2019
Estimated Primary Completion Date: January 15, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12-week physical activity program

The physical activity program is of moderate intensity and consists of aerobic, strength, flexibility, and balance training with a target duration of 150 minutes per week.

  • At study start, participants will be provided with a pedometer to objectively monitor their aerobic activity, variable weight ankle weights and a medical journal to record physical activity.
  • Exercise Trainer --A exercise trainer will be assigned to design a physical activity program.
Other: Physical Activity Program
12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.

Detailed Description:

The physical activity program is 12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.

  • The goal of the aerobic training is to complete 150 minutes per week of brisk walking.
  • The goals of the strength, flexibility, and balance training are to engage in these activities twice per week.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Start of trial:

    • A three-month of strict inclusion criteria (Phase 1).
    • At the end of three-months, if at least six participants have not been accrued, inclusion criteria will be expanded for a second three-month recruitment phase (Phase 2).
    • At the end of six-months, an average of two patients per month has not been accrued, a further expand inclusion criteria (Phase 3).
  • Phase 1 (most strict) Eligibility criteria include:

    • Voluntary, signed informed consent;
    • Diagnosis of histologically-confirmed esophageal, gastric, pancreatic, or colorectal that is metastatic or locally-advanced (unresectable);
    • First-line cytotoxic chemotherapy started within four-weeks of enrollment (patients can have reviewed prior adjuvant therapy if completed ≥6 months prior to start of first line chemotherapy for metastatic disease);
    • Age greater than 65 years;
    • Baseline physical activity less than 150 min∙wk-1 using the Paffenbarger physical activity questionnaire;
    • Eastern Cooperative Group Performance Status of 0, 1, or 2;
    • Self-reported ability to walk 400-meters (approximately one city block) without sitting, leaning, or the help of another person or walker;
    • Written physician approval;
    • Life expectancy >3 months;
    • English speaking.
  • Phase 2 (less restrictive) Eligibility criteria will loosen:

    -- The minimum age from greater than 65, to greater than 55;

  • Phase 3 (least restrictive) Eligibility criteria will add:

    -- The minimum age from greater than 55, to greater than 18.

  • Exclusion Criteria

    • Known or suspected brain or other central nervous system metastases;
    • Uncontrolled cardiac or pulmonary disease;
    • Pregnant or breast feeding;
    • Any other condition that may impede testing of the study hypothesis, make it unsafe to engage in the physical activity program, or make the participant not available for end of study assessments (determined by the investigative team).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331406


Contacts
Contact: Jeffrey Meyerhardt, MD 617-632-3687 JMEYERHARDT@PARTNERS.ORG

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jeffrey Meyerhardt, MD    877-601-8601      
Principal Investigator: Jeffrey Meyerhardt, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jeffrey Meyerhardt, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Jeffrey A. Meyerhardt, MD, Prinicipal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03331406     History of Changes
Other Study ID Numbers: 17-350
First Submitted: November 1, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute:
Metastatic gastrointestinal cancer
Physical Activity

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases