FatiguePhase 4NCT06819254
Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors
A Phase 4 study of Fatigue, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to find out if taking a Fisetin supplement can decrease fatigue among older cancer survivors. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Self-reported history of cancer diagnosed > 12 months prior to enrollment excluding non-melanoma skin cancer with no evidence of disease at enrollment.
- Eligible solid tumor cancer types include Stage 1-3 breast, lung, head and neck, colorectal, anal, prostate, melanoma, bladder/ureteral, esophageal, gastric, pancreatic, kidney, liver/biliary, uterine, cervical, ovarian, sarcoma. (superficial disease and in situ disease only is excluded)
- Eligible hematologic malignancies include lymphoma any subtype any stage in remission, multiple myeloma in remission, leukemia any subtype in remission.
- Eligible prior cancer treatment modalities include surgery, radiation, chemotherapy, hormonal therapies, immunotherapy, biologic therapies.
- All anti-cancer therapy completed > 6 months prior to enrollment with < 5 years from treatment
- Presence of self-reported fatigue defined by a response of "somewhat, quite a bit, or very much" to the screening question "During the past seven days, did you feel fatigued: Not at all, a little bit, somewhat, quite a bit, very much?"
- Ability to walk without requiring assistance from another individual (use of cane or walker acceptable)
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Who cannot join
- Unable or unwilling to give informed consent
- Female patients are of childbearing potential, defined as postmenopausal for at least 1 year.
- Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia
- Currently taking warfarin or Coumadin
- Currently taking a steroid medication either regularly or within the last two weeks.
- Patients currently taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, OATP1B1 (Unless willing and able to stop or modify the dosing of the drug) or strong inhibitors or inducers of CYP3A4 (e.g., cyclosporine, tacrolimus, or sirolimus) are excluded, unless medication can be safely held during the following times:
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- Immediately before the 1st IP administration (Day 0 or Day 30) until at least 10 hours after the 2nd IP administration (Day 1 or Day 31)
- Immediately before the 3rd IP administration (Day 7 or Day 37) until at least 10 hours after the 4th IP administration (Day 8 or Day 38)
- Subjects taking any of the medications listed in Appendix I may participate if they are otherwise eligible AND the medication can be safely held during the following times: Immediately before the 1st IP administration (Day 0 or Day 30) until at least 10 hours after the 2nd IP administration (Day 1 or Day 31); Immediately before the 3rd IP administration (Day 7 or Day 37) until at least 10 hours after the 4th IP administration (Day 8 or Day 38)
- Drugs listed as part of the exclusion criteria are not permitted during each of the two 2-day courses of treatment with Fisetin. If patients are required to initiate these medications within the 2-day period, they will be removed from the study primarily due to risk of drug-drug interaction.
- Uncontrolled hypertension (systolic >170 OR diastolic >100 mmHg) upon repeated assessments
- Uncontrolled (as per clinical judgement) pleural/pericardial effusions or ascites
- Active malignancy or on-going cancer treatment including oral anti-estrogen therapy, immunotherapy, biologic therapy.
- Men receiving androgen deprivation therapy
- Symptomatic congestive heart failure
- Lung disease requiring oxygen
- End stage renal disease requiring dialysis
- Inability to swallow capsules
- Chronic nausea or diarrhea defined by a frequency of ≥ once per week
- Diagnosis of dementia
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known untreated hypothyroidism
- Allergy to fisetin
- Human immunodeficiency virus infection
- Known active untreated hepatitis B or C infection
- Active invasive fungal infection
- Unwilling to provide informed consent, including consent to access electronic health records
- Judged unsuitable for the trial for any reason by research team
- The following laboratory tests as indicated or as per clinical judgement: Normal organ and marrow function as defined: Hemoglobin <10g/dL, leukocytes <3,000/mcL, absolute neutrophil count <1,500/mcL, platelets <100,000/mcL, total bilirubin above normal institutional limits, AST(SGOT)/ALT(SGPT) >2.5 X institutional upper limit of normal, creatinine clearance <30 mL/min, fasting glucose >300 on day of screening (from plasma or serum)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157
Kim Kennedy, MS, 336-713-8567, kennedy@wakehealth.edu
Stephen Kritchevsky, PhD
About this study
The purpose of this study is to find out if taking a Fisetin supplement can decrease fatigue among older cancer survivors.
Read the detailed description
Prospective double-blind placebo controlled, 14-day cross-over trial of patients aged 65 and over with a history of cancer with self-reported fatigue. Participants will be randomized and provided with Fisetin pills or placebo to take twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14 day wash-out. At the four-week visit participants will receive a cross-over placebo-controlled dosing regimen over two weeks. Follow-up phone calls for safety assessment and adherence review will occur at weeks 1 and 5. Follow-up assessments will be completed at 2, 4 and 6 weeks, and a post-treatment phone call assessment completed at 12 weeks.
- Conditions
- Fatigue
- Being tested
- Fisetin followed by Placebo, Placebo followed by Fisetin
- Keywords
- cancer survivor, supplement, Fisetin
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisetin followed by PlaceboDrug
Fisetin 20 mg/kg per dose twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14-day wash-out. At the 4-week visit participants will receive a cross-over placebo-controlled dosing regimen to be taken twice daily on two consecutive days for two consecutive weeks.
Placebo followed by FisetinDrug
Placebo twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14-day wash-out. At the 4-week visit participants will receive a cross-over Fisetin 20 mg/kg per dose twice daily on two consecutive days for two consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fisetin - Placebo | Experimental | Two-week regimen of Fisetin supplement followed by two-week regimen of placebo. Receives: Drug: Fisetin followed by Placebo |
| Placebo - Fisetin | Experimental | Two-week regimen of placebo followed by two-week regimen of Fisetin supplement. Receives: Drug: Placebo followed by Fisetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Measured: Baseline to Week 2
Change in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Measured: Baseline to Week 4
Change in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Measured: Baseline to Week 6
Change in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Measured: Baseline to Week 12
Secondary outcomes (8)
Change in Patient Reported Outcomes Measurement System (PROMIS)
PROMIS Fatigue Short-Form 7a - Item responses are rated on a five-point scale ranging from "never" to "always." Total score range is 5-35 with a higher scores indicating more fatigue.
Measured: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6, Baseline to Week 12
Change in Pepper Assessment Tool for Disability (PAT-D)
The (PAT-D) is a 19-item survey to assess domains of physical function in older adults. Responses are made on a five-point Likert scale ranging from "usually did with no difficulty" to "unable to do." Total score range is 19-95 with lower scores indicating better mobility and ability to perform activities of daily and instrumental activities of daily living.
Measured: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Expanded Short Physical Performance Battery (eSPPB)
eSPPB is used to objectively assess lower extremity physical function. This validated measure comprises a short walk, narrow walk, repeated chair stands, and balance tests. Total score range is 0-12 with higher scores indicating better physical performance. Lower scores on the eSPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer.
Measured: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in 6-minute Walk Distance
Distance participant is able to walk in 6-minute will be measured. The 6-minute walk accurately assesses submaximal exercise capacity and is an independent predictor of mortality and is correlated with peak V02 testing.
Measured: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Fried Frailty Phenotype Score
Frailty score is calculated using the Frailty Index Calculation form. Score range is 0-5 with a higher score indicating frailty.
Measured: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
10-item questionnaire used to measure sedentary behavior. The average time per 24 hours spent on each individual sedentary activity will be recorded in hours and/or minutes. This will be done for an average weekday as well as for an average weekend day. Ranges from 0-24 hours with a higher score indicating more sedentary behavior.
Measured: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in PROMIS Global Health Short Form
PROMIS Global Health Short Form is a 10-item instrument assesses the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. Higher scores reflect greater fatigue.
Measured: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Medication Adherence Rate
Empty bottles from home will be returned. The number of pills taken is calculated by subtracting the count of the number of pills remaining from the total number of pills dispensed. The drug adherence rate is then calculated by dividing the number of pills taken by the number of pills they were supposed to take.
Measured: Week 2, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start9 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1:1 randomization, cross-over design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Ambrose Monell Foundation
- Responsible party
- Sponsor
- Investigators
- Stephen Kritchevsky, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819254
- Sponsor's protocol ID
- IRB00125637
- Status last verified
- Dec 2025
- First submitted
- 27 Jan 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT06819254
- Acronym / sponsor ID
- IRB00125637
- Conditions
- Fatigue
- Keywords
- cancer survivor, supplement, Fisetin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Ambrose Monell Foundation
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Feb 2025 (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.
The purpose of this study is to find out if taking a Fisetin supplement can decrease fatigue among older cancer survivors.
Detailed description
Prospective double-blind placebo controlled, 14-day cross-over trial of patients aged 65 and over with a history of cancer with self-reported fatigue. Participants will be randomized and provided with Fisetin pills or placebo to take twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14 day wash-out. At the four-week visit participants will receive a cross-over placebo-controlled dosing regimen over two weeks. Follow-up phone calls for safety assessment and adherence review will occur at weeks 1 and 5. Follow-up assessments will be completed at 2, 4 and 6 weeks, and a post-treatment phone call assessment completed at 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Fisetin - Placebo | Experimental | Drug: Fisetin followed by PlaceboTwo-week regimen of Fisetin supplement followed by two-week regimen of placebo. |
| Placebo - Fisetin | Experimental | Drug: Placebo followed by FisetinTwo-week regimen of placebo followed by two-week regimen of Fisetin supplement. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Self-reported history of cancer diagnosed > 12 months prior to enrollment excluding non-melanoma skin cancer with no evidence of disease at enrollment.
- Eligible solid tumor cancer types include Stage 1-3 breast, lung, head and neck, colorectal, anal, prostate, melanoma, bladder/ureteral, esophageal, gastric, pancreatic, kidney, liver/biliary, uterine, cervical, ovarian, sarcoma. (superficial disease and in situ disease only is excluded)
- Eligible hematologic malignancies include lymphoma any subtype any stage in remission, multiple myeloma in remission, leukemia any subtype in remission.
- Eligible prior cancer treatment modalities include surgery, radiation, chemotherapy, hormonal therapies, immunotherapy, biologic therapies.
- All anti-cancer therapy completed > 6 months prior to enrollment with < 5 years from treatment
Key exclusion criteria (29 listed)
- Unable or unwilling to give informed consent
- Female patients are of childbearing potential, defined as postmenopausal for at least 1 year.
- Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia
- Currently taking warfarin or Coumadin
- Currently taking a steroid medication either regularly or within the last two weeks.
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 |
|---|---|---|
| Fisetin followed by PlaceboFisetin 20 mg/kg per dose twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14-day wash-out. At the 4-week visit participants will receive a cross-over placebo-controlled dosing regimen to be taken twice daily on two consecutive days for two consecutive weeks. | Drug | Fisetin - Placebo |
| Placebo followed by FisetinPlacebo twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14-day wash-out. At the 4-week visit participants will receive a cross-over Fisetin 20 mg/kg per dose twice daily on two consecutive days for two consecutive weeks. | Drug | Placebo - Fisetin |
Primary outcome
Change in Pittsburgh Fatigability Scale (PFS)
Time frame: Baseline to Week 2
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Change in Pittsburgh Fatigability Scale (PFS)
Time frame: Baseline to Week 4
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Change in Pittsburgh Fatigability Scale (PFS)
Time frame: Baseline to Week 6
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Change in Pittsburgh Fatigability Scale (PFS)
Time frame: Baseline to Week 12
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
8 secondary outcomes
Change in Patient Reported Outcomes Measurement System (PROMIS)
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6, Baseline to Week 12
Change in Pepper Assessment Tool for Disability (PAT-D)
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Expanded Short Physical Performance Battery (eSPPB)
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in 6-minute Walk Distance
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Fried Frailty Phenotype Score
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in PROMIS Global Health Short Form
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Medication Adherence Rate
Time frame: Week 2, Week 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- 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.
Stephen Kritchevsky, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Fatigue, run by Wake Forest University Health Sciences 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 8 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Kennedy (336-713-8567, kkennedy@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Fatigability Scale (PFS) (time frame: Baseline to Week 2). The study lists 4 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 15 Dec 2025.