Physical Activity In Gastrointestinal Cancer

Physical Activity Clinical Trial

Official title:

A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331406
• Other study ID #: 17-350
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Gastrointestinal Neoplasms
• Metastatic Gastrointestinal Cancer
• Physical Activity

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