Physical Activity In Gastrointestinal Cancer

NCT ID: NCT03331406

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-01-22

Brief Summary

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

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.

Conditions

Metastatic Gastrointestinal Cancer; Physical Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Activity Program

Intervention Type: OTHER

12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.

Interventions

Physical Activity Program

12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Start of trial:

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A. Meyerhardt, MD

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Meyerhardt, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Brown JC, Brighton E, Campbell N, McCleary NJ, Abrams TA, Cleary JM, Enzinger PC, Ng K, Rubinson D, Wolpin BM, Yurgelun MB, Meyerhardt JA. Physical activity in older adults with metastatic gastrointestinal cancer: a pilot and feasibility study. BMJ Open Sport Exerc Med. 2022 May 30;8(2):e001353. doi: 10.1136/bmjsem-2022-001353. eCollection 2022.

Reference Type: DERIVED

PMID: 35722047 (View on PubMed)

Other Identifiers

17-350

Identifier Type: -

Identifier Source: org_study_id