Metastatic Gastrointestinal CancerNCT03331406
Physical Activity In Gastrointestinal Cancer
A study testing Physical Activity Program in people with Metastatic Gastrointestinal Cancer and Physical Activity, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Gastrointestinal Cancer, Physical Activity
- What is being tested?
- Physical Activity Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 22 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer
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.
- Being tested
- Physical Activity Program
- Keywords
- Metastatic gastrointestinal cancer, Physical Activity
- Medical subject headings
- Gastrointestinal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity ProgramOther
12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.
| Study group | Role | What they receive |
|---|---|---|
| 12-week physical activity program | Experimental | 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. Receives: Other: Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Accrual
Recruit 20 patients within 12 months
Measured: 12 months
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.
Measured: 12 Weeks
Secondary outcomes (3)
Rate of Retention
Proportion of participants who complete the study
Measured: 12 Weeks
Number of participants that complete assessment procedures
Physical function testing and questionnaire collection
Measured: 12 Weeks
Number of participants with adverse events
Falls, hospitalizations, and musculoskeletal injury
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
- Investigators
- Jeffrey Meyerhardt, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331406
- Sponsor's protocol ID
- 17-350
- Status last verified
- Mar 2020
- First submitted
- 1 Nov 2017
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT03331406
- Acronym / sponsor ID
- 17-350
- Keywords
- Metastatic gastrointestinal cancer, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12-week physical activity program | Experimental | Other: Physical Activity ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Start of trial:
- Phase 1 (most strict) Eligibility criteria include:
- 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:
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Program12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training. | Other | 12-week physical activity program |
Primary outcome
Rate of Accrual
Time frame: 12 months
Recruit 20 patients within 12 months
Number of participants that adhered to physical activity program
Time frame: 12 Weeks
Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program.
3 secondary outcomes
Rate of Retention
Time frame: 12 Weeks
Number of participants that complete assessment procedures
Time frame: 12 Weeks
Number of participants with adverse events
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 35722047Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Meyerhardt, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Program in people with Metastatic Gastrointestinal Cancer and Physical Activity, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Accrual (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.