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

NCT06819254 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB00125637
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue

Keywords

cancer survivor; supplement; Fisetin

Outcome Measures

Primary Outcomes (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.

  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.

  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.

  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.

  Baseline to Week 12

Secondary Outcomes (8)

• Change in Patient Reported Outcomes Measurement System (PROMIS)

  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)

  Baseline to Week 2, Baseline to Week 4, Baseline to Week 6

• Change in Expanded Short Physical Performance Battery (eSPPB)

  Baseline to Week 2, Baseline to Week 4, Baseline to Week 6

• Change in 6-minute Walk Distance

  Baseline to Week 2, Baseline to Week 4, Baseline to Week 6

• Change in Fried Frailty Phenotype Score

  Baseline to Week 2, Baseline to Week 4, Baseline to Week 6

Study Arms (2)

Fisetin - Placebo

EXPERIMENTAL

Two-week regimen of Fisetin supplement followed by two-week regimen of placebo.

Drug: Fisetin followed by Placebo

Placebo - Fisetin

EXPERIMENTAL

Two-week regimen of placebo followed by two-week regimen of Fisetin supplement.

Drug: Placebo followed by Fisetin

Interventions

Placebo followed by Fisetin DRUG

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.

Placebo - Fisetin

Fisetin followed by Placebo DRUG

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.

Fisetin - Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• 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)
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• The Ambrose Monell Foundation: collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Kritchevsky, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Kennedy

CONTACT

336-713-8567; kkennedy@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization, cross-over design

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 11, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)