Actively Recruiting

Phase 4
Age: 65Years +
All Genders
Healthy Volunteers
NCT06819254

Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors

Led by Wake Forest University Health Sciences · Updated on 2025-12-15

60

Participants Needed

1

Research Sites

55 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

T

The Ambrose Monell Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to find out if taking a Fisetin supplement can decrease fatigue among older cancer survivors.

CONDITIONS

Official Title

Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • History of cancer diagnosed more than 12 months before enrollment, excluding non-melanoma skin cancer, with no current disease evidence
  • Eligible solid tumor cancers 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
  • Eligible hematologic cancers include lymphoma, multiple myeloma, and leukemia in remission
  • Prior cancer treatments can include surgery, radiation, chemotherapy, hormonal, immunotherapy, or biologic therapies
  • Completed all anti-cancer treatments more than 6 months but less than 5 years prior to enrollment
  • Self-reported fatigue defined as feeling "somewhat," "quite a bit," or "very much" fatigued during the past seven days
  • Ability to walk without assistance from another person (use of cane or walker is allowed)
  • Ability to understand and willing to sign informed consent (or via legally authorized representative)
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Female patients must be postmenopausal for at least 1 year if of childbearing potential
  • Prisoners, institutionalized people, or vulnerable populations such as individuals with dementia
  • Currently taking warfarin or Coumadin
  • Taking steroids regularly or within the last two weeks
  • Taking medications sensitive to CYP enzymes or strong inhibitors/inducers of CYP3A4 unless dosing can be safely modified or held during treatment periods
  • Uncontrolled high blood pressure (systolic >170 or diastolic >100 mmHg)
  • Uncontrolled pleural/pericardial effusions or ascites
  • Active cancer or ongoing cancer treatment including oral anti-estrogen therapy, immunotherapy, or biologic therapy
  • Men receiving androgen deprivation therapy
  • Symptomatic congestive heart failure
  • Lung disease requiring oxygen
  • End stage renal disease requiring dialysis
  • Unable to swallow capsules
  • Chronic nausea or diarrhea occurring at least once per week
  • Diagnosis of dementia
  • Uncontrolled illnesses such as infection, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
  • Untreated hypothyroidism
  • Allergy to fisetin
  • HIV infection
  • Active untreated hepatitis B or C
  • Active invasive fungal infection
  • Unwilling to provide consent including access to electronic health records
  • Judged unsuitable for the trial by research team
  • Abnormal lab values including low blood counts, elevated liver enzymes, low kidney function, or very high fasting glucose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Atrium Health Wake Forest Baptist Hospital

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

K

Kimberly Kennedy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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