Clinical trial · Interventional
Physical Activity In Gastrointestinal Cancer
A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer
NCT03331406CI-TRIAL-00043980completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Gastrointestinal Cancer | Malignant Digestive System Neoplasm | CURATED_BROADER | 0.78 |
| Physical Activity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Activity Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 12-week physical activity program
- description
- 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.
- interventionNames
- Other: Physical Activity Program
Primary outcomes (2)
- measure
- Rate of Accrual
- timeFrame
- 12 months
- description
- Recruit 20 patients within 12 months
- measure
- Number of participants that adhered to physical activity program
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDBrown 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. PMID 35722047