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CompletedNCT03331406Updated Mar 12, 2020

Physical Activity In Gastrointestinal Cancer

An interventional study of Physical Activity Program in Metastatic Gastrointestinal Cancer and Physical Activity, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Gastrointestinal Neoplasms by Dana-Farber Cancer Institute — 2 open to participants now, 3 under way, none of them phase 3. Gastrointestinal Neoplasms · Dana-Farber Cancer Institute.

Enrollment
10th of 12
20 · median 123
Started
2017
the only one that year
No phase
10 of 12
2 open now
Registered
3rd of 12
by date

Among the 12 studies in Gastrointestinal Neoplasms by Dana-Farber Cancer Institute, this one is the 10th largest by enrollment, is the only one that started in 2017, is one of 10 with no phase, and was the 3rd registered.

Gastrointestinal Neoplasms

695 studies on the registry are indexed under Gastrointestinal Neoplasms; 209 are open to participants now.

Browse Gastrointestinal Neoplasms studies →

Open to participants now

2 of the 12 studies in Gastrointestinal Neoplasms by Dana-Farber Cancer Institute are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 160 Gastrointestinal Neoplasms studies recruiting now, 122 (76%) set no upper age limit and 18 (11%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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.
03

Conditions studied

  • Metastatic Gastrointestinal Cancer
  • Physical Activity

Keywords

  • Metastatic gastrointestinal cancer
  • Physical Activity
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;
    • Diagnosis of -confirmed esophageal, gastric, pancreatic, or colorectal that is or locally-advanced (unresectable);
    • cytotoxic chemotherapy started within four-weeks of enrollment (patients can have reviewed prior 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;
    • >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 ;

    • 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).
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    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.

    Other: Physical Activity Program

Interventions

  • OtherPhysical Activity Program

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

06

What researchers measure

Primary outcomes

  1. Rate of Accrual

    Recruit 20 patients within 12 months

    Time frame: 12 months

  2. 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.

    Time frame: 12 Weeks

Secondary outcomes

  1. Rate of Retention

    Proportion of participants who complete the study

    Time frame: 12 Weeks

  2. Number of participants that complete assessment procedures

    Physical function testing and questionnaire collection

    Time frame: 12 Weeks

  3. Number of participants with adverse events

    Falls, hospitalizations, and musculoskeletal injury

    Time frame: 12 Weeks

07

Study locations

1 site
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • 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. PubMed 35722047 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jan 2019, 13 months.

Of 153 non-industry interventional studies with no phase under Gastrointestinal Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 71. This study's 13 months is below that.

Counting every sponsor, half of 163 studies reached it within 35 months; a quarter within 17 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2017
First posted
Nov 6, 2017
StartActual
Dec 1, 2017
Primary completionActual
Jan 22, 2019
CompletionActual
Jan 22, 2019
Last update
Mar 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03331406
Responsible party
Jeffrey A. Meyerhardt, MD (Prinicipal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Nov 6, 2017
Start date
Dec 1, 2017
Primary completion
Jan 22, 2019
Completion
Jan 22, 2019
Last update
Mar 12, 2020

Study contacts

Jeffrey Meyerhardt, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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