Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT05595499
Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors
A Phase 2 study testing Biospecimen Collection, Fisetin and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 7 sites in United States.
Trial summary
This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Fisetin and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Mar 2023to 14 Aug 2028
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who are postmenopausal at the start of study treatment.
- Postmenopausal status will be established as follows:
- Women aged: >= 60 years OR
- Women aged < 60 years AND one of the following conditions is met:
- They have not had any menstrual periods for at least 12 months in the absence of exogenous hormonal treatments, chemotherapy, and/or tamoxifen AND have serum estradiol and follicle-stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for postmenopausal females.
- They have documented irreversible bilateral oophorectomy.
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- They are receiving ovarian suppression with their breast cancer endocrine therapy
- Women with a diagnosis of early-stage breast cancer (Stage I-III) treated with neo/adjuvant chemotherapy within 12 months of starting study treatment
- No evidence of active/recurrent breast cancer or other serious chronic illnesses
- Have evidence of frail health, defined as a diminished 6-minute walk distance (< 400m) at baseline
- Platelets > 60,000/mm^3
- White blood cell count > 2,000/mm^3
- Absolute neutrophil count > 500/mm^3
- Hemoglobin >= 8.0 g/dL
- Total bilirubin =< 3.0 X upper limit of normal (ULN)
- Aspartate aminotransferase (AST) =< 4.0 x ULN
- Alanine aminotransferase (ALT) =< 4.0 x ULN
- Estimated glomerular filtration rate (eGFR) of >= 30mL/min/1.73m^2 per the Modification of Diet in Renal Disease (MDRD) calculation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, ribociclib, abemaciclib, aromatase inhibitors and/or ovarian suppression.
- Surgery and/or radiation within the last 30 days of starting study treatment (Exception: invasive non- major procedures such as an outpatient biopsy)
- Subjects taking medications that are considered prohibited.
- Exception: Subjects taking any of the medications listed in under "Temporary medication adjustment required" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, for each dosing interval)
- On herbal and natural medications with possible senolytic properties (i.e., curcumin, kava kava, St. John's wort) and are unable or unwilling to hold its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications may be permitted or prohibited per clinician discretion
- Subjects taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax
Show all 10Show fewer
- Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)
- Issues with tolerating oral medication (such as but not limited to, inability to swallow pills (g-tubes not allowed), malabsorption issues, ongoing nausea or vomiting during screening, history of Crohn's, gastric bypass/reduction, or celiac disease)
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion/fatigue, or cognitive function
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
UCLA Health Cancer Care in Alhambra
Alhambra, California, 91801
Mina S. Sedrak, MD, 310-825-3181, msedrak@mednet.ucla.edu
- Recruiting
UCLA Health Beverly Hills Primary & Specialty Care
Beverly Hills, California, 90210
Mina S. Sedrak, MD, 310-825-3181, msedrak@mednet.ucla.edu
- Recruiting
UCLA Health Burbank Primary & Specialty Care
Burbank, California, 91505
Mina S. Sedrak, MD, 310-825-3181, msedrak@mednet.ucla.edu
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Keilani Luna, 909-809-9338, kluna@coh.org
Marie D. Yee, MD, 626-256-4673 ext. 85200, lyee@coh.org
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Mina S. Sedrak, 310-825-3181, msedrak@mednet.ucla.edu
Mina S. Sedrak
- Recruiting
UCLA Health Primary Care in Marina del Rey
Marina del Rey, California, 90292
Mina S. Sedrak, MD, 310-825-3181, msedrak@mednet.ucla.edu
- Recruiting
UCLA Health Primary Care in Pasadena
Pasadena, California, 91105
Mina S. Sedrak, MD, 310-825-3181, msedrak@mednet.ucla.edu
About this study
Official title: A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors
This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the effect of fisetin on physical function, as assessed using the 6-minute walk distance (6MWD), in frail older breast cancer survivors.
SECONDARY OBJECTIVES:
- To determine the effect of fisetin on other measures of physical function (grip strength, short physical performance battery [SPPB], frailty phenotype, physical function component of the 36 item short form survey [SF-36]).
II. To determine the effect of fisetin on fatigability (Borg Rating of Perceived Exertion [RPE]).
III. To determine the effect of fisetin on neuropathy (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 [QLQ-CIPN20]).
IV. To determine the effect of fisetin on cognitive function (Patient Reported Outcomes Measurement Information System [PROMIS] cognitive function short form).
- To determine the effect of fisetin on health-related quality of life (SF-36).
VI. To determine the effect of fisetin on sleep (Insomnia Severity Index [ISI]).
VII. To determine the effect of fisetin on anxiety (GAD-7). VIII. To determine the effect of fisetin on depression (PHQ-8). IX. To determine the effect of fisetin on local and distant recurrence free survival.
- To determine the effect of fisetin on breast cancer specific survival and overall survival.
XI. To evaluate the safety and tolerability of fisetin (physician and patient-reported Common Terminology Criteria for Adverse Events [CTCAEs]).
XII. To estimate rates of adherence to fisetin (pill diary).
EXPLORATORY OBJECTIVES:
- To determine the effect of fisetin on p16 expression in peripheral CD3+ T-cells.
II. To determine the effect of fisetin on circulating senescence-associated secretory phenotype (SASP) inflammatory factors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive fisetin orally (PO) on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.
ARM B: Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up yearly for up to 3 years.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- Biospecimen Collection, Fisetin, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
FisetinDrug
Also called 3,3',4',7-Tetrahydroxyflavone, 7,3',4'-Flavon-3-ol
Given PO
Placebo AdministrationDrug
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (fisetin) | Experimental | Patients receive fisetin PO on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial. Receives: Procedure: Biospecimen Collection; Drug: Fisetin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm B (placebo) | Placebo comparator | Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial. Receives: Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walk distance (6MWD)
The 6MWD is a validated measure of physical function. Participants walk at their own pace for 6 minutes and distance (in meters) is measured at the end. Will be treated as a continuous variable. Its distribution will be transformed to normality as appropriate, Initially, a simple t-test will be used to compare the means of 6MWD at Day 60 by treatment groups.
Measured: Baseline to day 60
Secondary outcomes (17)
Change in grip strength
Generalized estimating equation (GEE) models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to access change in grip strength.
Grip strength will be obtained using a hand dynamometer.
Measured: From baseline to day 60
Change in Short Physical Performance Battery score
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to access change in short physical performance battery score.
Measured: From baseline to day 60
Change in frailty phenotype
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in physical function component of 36-item Short Form (SF-36)
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in the Borg Rating of Perceived Exertion score
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 scores
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in Patient Reported Outcomes Measurement Information System cognitive function short form score
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in composite SF-36 score
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in sleep (Insomnia Severity Index score)
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in anxiety (Generalized Anxiety Disorder-7 score)
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Change in depression (Patient Health Questionnaire-8 score)
GEE models will be fitted. The variables also will be dichotomized (e.g., < median, >= median) and GEE models for binary data used to test treatment effects over time.
Measured: From baseline to day 60
Local recurrence free survival
Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Distant recurrence free survival
Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Breast cancer specific survival and overall survival
Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Overall survival
Will be compared between fisetin and placebo using the stratified log-rank test. The stratified Cox regression model will be used to obtain the estimate of the hazard ratio and the 95% confidence interval. The distributions of various survival endpoints will be estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Adverse events rates
Measured by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5. Adverse events will be determined at each time point per patient as the presence (yes/no) of toxicities (CTCAE v 5.0) of grade >= 2. The number of patients with adverse events will be compared by treatment arms using Fisher's exact test. GEE models for binary data will also be used to compare the proportion of patients with adverse events over time by treatment.
Measured: Up to 90 days
Adherence rate
Measured by pill diary. Treatment adherence (yes/no) for each patient at each time point will be determined. A patient will be considered adherent (coded 1) if she took all the required capsules within the allotted time, and non-adherent (coded 0) otherwise. The number of capsules taken in the allotted time out of the total required will also be recorded. Will then compare between treatments the proportion of adherent patients and the average proportion of capsules taken within the allotted time across patients at each time point using the t-test. Time point-specific analysis will be performed since conditions for pill-taking differ between the clinic (supervised) and patients' home (self-administered).
Measured: From baseline up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start27 Mar 2023
- Primary completion14 Aug 2027 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mina S. Sedrak, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595499
- Sponsor's protocol ID
- 23-001170
- Other IDs
- NCI-2022-08061, P30CA016042, R21CA277660, K76AG074918
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ji J, Crespi CM, Yee L, Zekster YA, Al-Saleem A, Petersen L, Lee C, Son N, Smith C, Evans T, Tchkonia T, Kirkland JL, Kuchel GA, Cohen HJ, Sedrak MS. A phase II randomized placebo-controlled study of fisetin to improve physical function in breast cancer survivors: the TROFFi study rationale and trial design. Ther Adv Med Oncol. 2026 Mar 11;18:17588359261424668. doi: 10.1177/17588359261424668. eCollection 2026.
PubMed 41835341
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05595499
- Acronym / sponsor ID
- 23-001170
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Aging (NIA)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 14 Aug 2027 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 27 Oct 2022 (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.
This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- To determine the effect of fisetin on physical function, as assessed using the 6-minute walk distance (6MWD), in frail older breast cancer survivors.
SECONDARY OBJECTIVES:
- To determine the effect of fisetin on other measures of physical function (grip strength, short physical performance battery [SPPB], frailty phenotype, physical function component of the 36 item short form survey [SF-36]).
II. To determine the effect of fisetin on fatigability (Borg Rating of Perceived Exertion [RPE]).
III. To determine the effect of fisetin on neuropathy (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 [QLQ-CIPN20]).
IV. To determine the effect of fisetin on cognitive function (Patient Reported Outcomes Measurement Information System [PROMIS] cognitive function short form).
- To determine the effect of fisetin on health-related quality of life (SF-36).
VI. To determine the effect of fisetin on sleep (Insomnia Severity Index [ISI]).
VII. To determine the effect of fisetin on anxiety (GAD-7). VIII. To determine the effect of fisetin on depression (PHQ-8). IX. To determine the effect of fisetin on local and distant recurrence free survival.
- To determine the effect of fisetin on breast cancer specific survival and overall survival.
XI. To evaluate the safety and tolerability of fisetin (physician and patient-reported Common Terminology Criteria for Adverse Events [CTCAEs]).
XII. To estimate rates of adherence to fisetin (pill diary).
EXPLORATORY OBJECTIVES:
- To determine the effect of fisetin on p16 expression in peripheral CD3+ T-cells.
II. To determine the effect of fisetin on circulating senescence-associated secretory phenotype (SASP) inflammatory factors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive fisetin orally (PO) on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.
ARM B: Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up yearly for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (fisetin) | Experimental | Procedure: Biospecimen Collection, Drug: Fisetin, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive fisetin PO on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial. |
| Arm B (placebo) | Placebo comparator | Procedure: Biospecimen Collection, Drug: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Women who are postmenopausal at the start of study treatment.
- Women aged: >= 60 years OR
- Women aged < 60 years AND one of the following conditions is met:
Key exclusion criteria (10 listed)
- Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, ribociclib, abemaciclib, aromatase inhibitors and/or ovarian suppression.
- Surgery and/or radiation within the last 30 days of starting study treatment (Exception: invasive non- major procedures such as an outpatient biopsy)
- Subjects taking medications that are considered prohibited.
- On herbal and natural medications with possible senolytic properties (i.e., curcumin, kava kava, St. John's wort) and are unable or unwilling to hold its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications may be permitted or prohibited per clinician discretion
- Subjects taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Arm A (fisetin), Arm B (placebo) |
| FisetinAlso: 3,3',4',7-Tetrahydroxyflavone, 7,3',4'-Flavon-3-olGiven PO | Drug | Arm A (fisetin) |
| Placebo AdministrationGiven PO | Drug | Arm B (placebo) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (fisetin), Arm B (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (fisetin), Arm B (placebo) |
Primary outcome
Change in 6-minute walk distance (6MWD)
Time frame: Baseline to day 60
The 6MWD is a validated measure of physical function. Participants walk at their own pace for 6 minutes and distance (in meters) is measured at the end. Will be treated as a continuous variable. Its distribution will be transformed to normality as appropriate, Initially, a simple t-test will be used to compare the means of 6MWD at Day 60 by treatment groups.
17 secondary outcomes
Change in grip strength
Time frame: From baseline to day 60
Change in Short Physical Performance Battery score
Time frame: From baseline to day 60
Change in frailty phenotype
Time frame: From baseline to day 60
Change in physical function component of 36-item Short Form (SF-36)
Time frame: From baseline to day 60
Change in the Borg Rating of Perceived Exertion score
Time frame: From baseline to day 60
Change in Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 scores
Time frame: From baseline to day 60
Change in Patient Reported Outcomes Measurement Information System cognitive function short form score
Time frame: From baseline to day 60
Change in composite SF-36 score
Time frame: From baseline to day 60
Change in sleep (Insomnia Severity Index score)
Time frame: From baseline to day 60
Change in anxiety (Generalized Anxiety Disorder-7 score)
Time frame: From baseline to day 60
Change in depression (Patient Health Questionnaire-8 score)
Time frame: From baseline to day 60
Local recurrence free survival
Time frame: Up to 3 years
Distant recurrence free survival
Time frame: Up to 3 years
Breast cancer specific survival and overall survival
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years
Adverse events rates
Time frame: Up to 90 days
Adherence rate
Time frame: From baseline up to 30 days
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 17 Jul 2026.
- Derived from this study: PubMed 41835341Ji J, Crespi CM, Yee L, Zekster YA, Al-Saleem A, Petersen L, Lee C, Son N, Smith C, Evans T, Tchkonia T, Kirkland JL, Kuchel GA, Cohen HJ, Sedrak MS. A phase II randomized placebo-controlled study of fisetin to improve physical function in breast cancer survivors: the TROFFi study rationale and trial design. Ther Adv Med Oncol. 2026 Mar 11;18:17588359261424668. doi: 10.1177/17588359261424668. eCollection 2026.
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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.
Mina S. Sedrak, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Fisetin and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 7 sites 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 19 inclusion and 10 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mina S. Sedrak, MD (310-825-3181, msedrak@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk distance (6MWD) (time frame: Baseline to day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595499, which also lists 1 linked publication.
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 17 Jul 2026.