Clinical trial NCT03331406: Physical Activity In Gastrointestinal Cancer
Official title: A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Gastrointestinal Cancer
Physical Activity
Keywords: Metastatic gastrointestinal cancer
Physical Activity
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 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).

Primary outcomes:
measure: Rate of Accrual
timeFrame: 12 months
measure: Number of participants that adhered to physical activity program
timeFrame: 12 Weeks
Secondary outcomes:
measure: Rate of Retention
timeFrame: 12 Weeks
measure: Number of participants that complete assessment procedures
timeFrame: 12 Weeks
measure: Number of participants with adverse events
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jeffrey Meyerhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.