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New treatment option for Fatigue
Official title Exercise to ReGain Stamina and Energy (The EXERGISE Study)
ClinicalTrials.gov ID: NCT05684367
What this study is testing
- What it's testing
- About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 105, women only
You may be able to join if
- Consent to participate in the study
- Age ≥ 60 years old
- Had stage I-III invasive breast cancer
- The cancer is diagnosed in 2021 or 2022
- Completed adjuvant therapy for at least 3 months but no more than 1 year
You likely can't join if
- Failure to provide informed consent
- Current involvement in rehabilitation program
- Absolute contraindications to exercise training
- Significant cognitive impairment
- Progressive, degenerative neurologic disease
- Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
See the full eligibility criteria
- Consent to participate in the study
- Age ≥ 60 years old
- Had stage I-III invasive breast cancer
- The cancer is diagnosed in 2021 or 2022
- Completed adjuvant therapy for at least 3 months but no more than 1 year
- Willingness to participate in all study procedures
- Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)
- Failure to provide informed consent
- Current involvement in rehabilitation program
- Absolute contraindications to exercise training
- Significant cognitive impairment
- Progressive, degenerative neurologic disease
- Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
- Other significant comorbidities that may impair ability to participate in the exercise intervention
- Pregnant
- Regular consumption of nicotinamide riboside supplement
- Simultaneous participation in other treatment studies
- Had no or very mild fatigue (defined as raw score ≤7 in PROMIS)
- Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic...
- Receipt of any oral or intravenous antibiotic 4 weeks prior to screening
- Receipt of any probiotics within 4 weeks of screening
- History of active treatment for HIV, hepatitis B, or hepatitis C infection
- Positive stool cultures for enteric pathogens, including Clostridium difficile
- Excessive alcohol use (i.e., \> 14 drinks/week) or alcohol abuse (i.e., \> 5 drinks/day for males or \> 4 drinks/day for females)
- Other substance abuse within the past 3 years
- Smoking history in past 3 years
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years to 105 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.