Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

Part of paid clinical trials in Alhambra, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT06113016
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Early Stage Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Educational Intervention — OTHER
    Receive handout on physical activity
  • Exercise Intervention — OTHER
    Receive individually tailored exercise intervention
  • Fisetin — DRUG
    Given PO
  • Physical Performance Testing — OTHER
    Ancillary studies
  • Placebo Administration — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial tests how well fisetin and exercise works in preventing frailty in breast cancer survivors. Fisetin is a natural substance found in strawberries and other foods and is available as a nutritional supplement. Nutritional supplements may be useful in eliminating 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 cause inflammation and damage nearby healthy cells. Giving fisetin may eliminate senescent cells in patients with breast cancer undergoing physical activity.

Key Dates

Start date
Jul 23, 2024
Status verified
Jun 2025
Primary completion
Jun 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Arm A (fisetin, physical activity handout)
    Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
  • Experimental: Arm AB (fisetin, tailored exercise training)
    Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
  • Active Comparator: Arm B (placebo, tailored exercise training)
    Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
  • Active Comparator: Arm C (placebo, physical activity handout)
    Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.

Primary Outcome Measure

Change in 6 minute walk distance (6MWD) [ Time Frame: From baseline to day 120 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UCLA Health Cancer Care in AlhambraAlhambraCalifornia91801
Mina S. Sedrak, MD
[email protected]
310-825-3181
UCLA Health Beverly Hills Primary & Specialty CareBeverly HillsCalifornia90210
Mina S. Sedrak, MD
[email protected]
310-825-3181
UCLA Health Burbank Primary & Specialty CareBurbankCalifornia91505
Mina S. Sedrak, MD
[email protected]
310-8253181
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Mina S. Sedrak
[email protected]
310-825-3181
Mina S. Sedrak (PRINCIPAL_INVESTIGATOR)
UCLA Health Primary Care in Marina del ReyMarina del ReyCalifornia90292
Mina S. sedrak, MD
[email protected]
310-825-3181
UCLA Health Primary Care in PasadenaPasadenaCalifornia91105
Mina S. Sedrak, MD
[email protected]
310-825-3181

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UCLA Health Cancer Care in Alhambra· Alhambra, CAUCLA Health Beverly Hills Primary & Specialty Care· Beverly Hills, CAUCLA Health Burbank Primary & Specialty Care· Burbank, CAUCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUCLA Health Primary Care in Marina del Rey· Marina del Rey, CAUCLA Health Primary Care in Pasadena· Pasadena, CA

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