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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03331406
Other study ID # 17-350
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date January 22, 2019

Study information

Verified date March 2020
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 22, 2019
Est. primary completion date January 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 weight-bearing 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical Activity Program
12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.

Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Accrual Recruit 20 patients within 12 months 12 months
Primary Number of participants that adhered to physical activity program Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program. 12 Weeks
Secondary Rate of Retention Proportion of participants who complete the study 12 Weeks
Secondary Number of participants that complete assessment procedures Physical function testing and questionnaire collection 12 Weeks
Secondary Number of participants with adverse events Falls, hospitalizations, and musculoskeletal injury 12 Weeks
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