15 Participants NeededMy employer runs this trial

Prolonged Fasting for Breast Cancer

LC
Overseen ByLisa Chow, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
Must be taking: Capivasertib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether prolonged fasting can enhance the effects of PI3K inhibitors, a type of cancer treatment, in people with metastatic breast cancer. The study compares two approaches: starting with normal eating and then switching to fasting, or starting with fasting and then returning to normal eating. Participants must have a diagnosis of metastatic breast cancer and currently be on a stable capivasertib treatment plan to qualify.

As an unphased trial, this study allows participants to contribute to innovative research that could improve future cancer treatments.

Do I have to stop taking my current medications for the trial?

The trial requires participants to continue taking capivasertib as part of their current treatment. There is no mention of stopping other medications, so it's best to discuss your specific situation with the trial team.

What prior data suggests that prolonged fasting is safe for breast cancer patients?

Research has shown that fasting for long periods might be safe and beneficial for people with breast cancer. Some studies suggest that fasting for 13 hours or more each night could help lower the chance of cancer returning. For instance, one study found that fasting helped patients lose weight and improved their health markers, although it didn't significantly change the effects of chemotherapy.

Many patients reported fasting as a positive experience. About 12.5% said it helped with nausea, and 50% felt less tired. However, some people might find it hard to follow a fasting routine.

Overall, while fasting for longer periods looks promising and many people handle it well, it's important to consider individual health needs and consult a doctor before starting.12345

Why are researchers excited about this trial?

Researchers are excited about prolonged fasting for breast cancer because it offers a unique, non-drug approach that could complement traditional treatments like chemotherapy and hormonal therapy. Unlike conventional methods that directly target cancer cells, prolonged fasting may work by enhancing the body's natural defense mechanisms and potentially making cancer cells more vulnerable to existing treatments. Additionally, this approach could be less invasive and have fewer side effects compared to standard therapies, offering a new avenue for improving patient outcomes with minimal risk.

What evidence suggests that prolonged fasting could be effective for metastatic breast cancer?

Research has shown that fasting for 13 hours or more at night might help treat breast cancer. Studies suggest that this fasting can lower the chance of breast cancer returning. It may also enhance cancer treatments by boosting their effects and slowing the body's resistance to drugs. Additionally, fasting has been linked to slowing tumor growth and improving overall cancer outcomes. This trial will compare two sequences: one where participants start with normal eating followed by prolonged fasting, and another where they begin with prolonged fasting followed by normal eating. While more research is needed, these findings suggest that fasting could be a useful addition to breast cancer treatment.12345

Who Is on the Research Team?

LC

Lisa Chow, MD, MS

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for people with metastatic breast cancer who are being treated with PI3K inhibitors. Participants should be able to safely try periods of fasting and must meet other health requirements set by the study team.

Inclusion Criteria

Menopausal or medically ovarian suppressed
BMI ≥25kg/m2
Able to provide informed consent
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Exclusion Criteria

History of significantly abnormal lab results within 4 weeks of consent date, including hematologic (Hgb < 10.0, platelets < 100), hepatic (LFTs > 2X normal), renal (Creatinine > 1.5)
Pregnancy or breastfeeding
Unable to fast for medical reasons
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sequences of normal eating, washout, and prolonged fasting to assess the effects on PI3K inhibitors in metastatic breast cancer treatment

7 weeks
Weekly visits for monitoring and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Prolonged Fasting

Trial Overview

The study is testing whether prolonged fasting, combined with standard treatment using PI3K inhibitors, is acceptable and possibly helpful for people with advanced breast cancer.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Sequence AActive Control2 Interventions
Group II: Sequence BActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Prolonged Nightly Fasting and Breast Cancer Prognosis - PMC

Taken together, the rodent and human data support the hypothesis that a prolonged nightly fasting interval could reduce cancer risk and improve cancer outcomes.

Fasting boosts breast cancer therapy efficacy via ...

Periodic fasting enhances the efficacy of standard endocrine therapy and delays acquired drug resistance, although the underlying mechanisms ...

XRAY: Can long periods of fasting protect against breast ...

A new study associates prolonged fasting (13 hours or more) at night with a lower risk of breast cancer recurrence, but no association between fasting time

Can Fasting 13 Hours or More at Night Reduce ...

A study suggests that waiting 13 or more hours to eat again after the evening meal may reduce the risk of early-stage breast cancer coming back (recurrence).

Fasting as Cancer Treatment: Myth or Breakthrough in Oncology

These studies have shown promising results, indicating that fasting could reduce tumor growth cells, by enhancing the sensitivity of cancer ...