Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Women who are postmenopausal at the start of study treatment

Postmenopausal status will be established as follows: Women who are 50 years or older and who are not menstruating for greater than 12 months will be considered postmenopausal. Women who are less than 50 years with an intact uterus and ovaries must have chemically induced menopause (e.g., ovarian suppression) to be considered postmenopausal

Women with a diagnosis of early-stage breast cancer (stage I, II, 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

Disqualifiers

Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, and aromatase inhibitors

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 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)

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Educational Intervention
  • Exercise Intervention
  • Fisetin
  • Physical Performance Testing
  • Placebo Administration
  • Quality-of-Life Assessment
  • Questionnaire Administration

Treatment groups

164 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Jonsson Comprehensive Cancer Center

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Rising Tide Foundation

Collaborator