Thyroid CancerNCT04224792
Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
A study testing Center-based exercise program and Home-based exercise program in people with Thyroid Cancer, run by Mayo Clinic.
Trial summary
Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Center-based exercise program and Home-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 30 Dec 2024
- 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
- Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer.
- English speaking
- Able to provide consent
Who cannot join
- Pregnant
- Medullary thyroid cancer
- Anaplastic thyroid cancer
- Physical limitations to perform exercise
About this study
Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.
- Conditions
- Thyroid Cancer
- Being tested
- Center-based exercise program, Home-based exercise program
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-based exercise programOther
A routine individualized exercise prescription and supervised exercise sessions at a minimum of once per week for 11 weeks with an exercise prescription updated monthly.
Home-based exercise programOther
A one-time supervised exercise session with Cardiac Rehabilitation staff and a routine individualized exercise prescription for exercises to do at home. Additionally, weekly telephone followup calls by a clinical exercise physiologist for 11 weeks consisting of an exercise tip.
| Study group | Role | What they receive |
|---|---|---|
| Center-based exercise group | Experimental | Subjects will be enrolled into a center-based exercise program. Receives: Other: Center-based exercise program |
| Home-based exercise group | Experimental | Subjects will be enrolled into a home-based exercise program. Receives: Other: Home-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue symptoms
Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey
Measured: Baseline, 12 weeks
Physical activity
Change in physical activity measured using the self-reported International Physical Activity questionnaire
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start30 Sep 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Due to pandemic, unable to see patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Regina Castro, Mayo Clinic
- Investigators
- Regina Castro, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224792
- Sponsor's protocol ID
- 19-008397
- Status last verified
- Jun 2022
- First submitted
- 8 Jan 2020
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
- ClinicalTrials.gov ID
- NCT04224792
- Acronym / sponsor ID
- 19-008397
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to pandemic, unable to see patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Jan 2020 (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.
Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Center-based exercise group | Experimental | Other: Center-based exercise programSubjects will be enrolled into a center-based exercise program. |
| Home-based exercise group | Experimental | Other: Home-based exercise programSubjects will be enrolled into a home-based exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer.
- English speaking
- Able to provide consent
Key exclusion criteria (4 listed)
- Pregnant
- Medullary thyroid cancer
- Anaplastic thyroid cancer
- Physical limitations to perform exercise
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 |
|---|---|---|
| Center-based exercise programA routine individualized exercise prescription and supervised exercise sessions at a minimum of once per week for 11 weeks with an exercise prescription updated monthly. | Other | Center-based exercise group |
| Home-based exercise programA one-time supervised exercise session with Cardiac Rehabilitation staff and a routine individualized exercise prescription for exercises to do at home. Additionally, weekly telephone followup calls by a clinical exercise physiologist for 11 weeks consisting of an exercise tip. | Other | Home-based exercise group |
Primary outcome
Fatigue symptoms
Time frame: Baseline, 12 weeks
Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey
Physical activity
Time frame: Baseline, 12 weeks
Change in physical activity measured using the self-reported International Physical Activity questionnaire
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Regina Castro, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Center-based exercise program and Home-based exercise program in people with Thyroid Cancer, run by Mayo Clinic.
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 3 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: withdrawn, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Fatigue symptoms (time frame: Baseline, 12 weeks). 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?
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 9 Jun 2022.