30 Participants Needed

Fasting Mimicking Diet for Ovarian Cancer

JD
MW
Overseen ByMin Wei, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you take daily medications that cannot be safely taken without food.

What data supports the effectiveness of the Fasting Mimicking Diet treatment for ovarian cancer?

Research shows that the Fasting Mimicking Diet (FMD) can enhance the effectiveness of cancer treatments in general. It has been found to improve responses to chemotherapy in breast cancer and shows potential in making cancer cells more sensitive to treatment while protecting healthy cells.12345

Is the fasting mimicking diet generally safe for humans?

The fasting mimicking diet (FMD) is considered a safer and less challenging option compared to other dietary restrictions, and it has been tested in more than ten clinical trials to evaluate its safety when combined with cancer treatments.12345

How does the fasting mimicking diet treatment differ from other treatments for ovarian cancer?

The fasting mimicking diet (FMD) is unique because it involves cycles of low-calorie, low-carbohydrate, and low-protein intake, which can enhance the effects of standard cancer treatments like chemotherapy. Unlike traditional treatments that focus solely on medication, FMD works by mimicking the effects of fasting, potentially improving the body's response to cancer therapies.12367

Research Team

JD

Jonathan Boone

Principal Investigator

The University of Tennessee Medical Center

Eligibility Criteria

This trial is for patients with gynecologic cancers such as ovarian cancer, who are undergoing chemotherapy. It's designed to see if a special diet that mimics fasting can help manage the side effects of their treatment.

Inclusion Criteria

I am between 35 and 70 years old.
My cancer diagnosis was confirmed with a biopsy.
I am scheduled for or currently receiving chemotherapy, with at least 6 treatments left.
See 4 more

Exclusion Criteria

I do not have recent severe heart issues, stroke, kidney failure, eating disorders, dementia, psychosis, or mobility problems.
Taking daily medications that cannot be safely taken without food
Pregnant or nursing mothers
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy with or without a fasting mimicking diet for 21 weeks

21 weeks
Regular visits aligned with chemotherapy schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Fasting Mimicking Diet
Trial Overview The study is testing whether a Fasting Mimicking Diet alongside standard chemotherapy can reduce the negative side effects associated with chemo in patients with gynecologic malignancies.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: FMDExperimental Treatment2 Interventions
In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
Group II: ControlActive Control1 Intervention
Subjects will receive the standard care and no dietary changes.

Find a Clinic Near You

Who Is Running the Clinical Trial?

L-Nutra Inc

Lead Sponsor

Trials
10
Recruited
730+

University of Tennessee Medical Center

Collaborator

Trials
7
Recruited
450+

Findings from Research

In a phase II study involving 129 patients with HER2-negative breast cancer, a fasting mimicking diet (FMD) improved patients' perceptions of chemotherapy side effects and overall quality of life compared to a regular diet.
Patients adhering to the FMD reported better emotional, physical, and social functioning, along with lower levels of fatigue, nausea, and insomnia, suggesting that FMD may enhance the supportive care during neoadjuvant chemotherapy.
Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial.Lugtenberg, RT., de Groot, S., Kaptein, AA., et al.[2021]
In a phase Ib trial involving 101 patients with advanced cancer, cyclic fasting-mimicking diets (FMDs) were found to be safe and feasible when combined with standard cancer treatments, showing positive metabolic and immunologic changes.
Remarkably, five patients with poor prognosis solid tumors achieved complete and long-lasting tumor remissions, suggesting that cyclic FMD may enhance the effectiveness of standard anticancer therapies.
Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial.Ligorio, F., Fucà, G., Provenzano, L., et al.[2022]
Fasting or a fasting-mimicking diet (FMD) can slow down tumor growth but does not enhance the sensitivity of colorectal cancer (CRC) cells to chemotherapy drugs like 5-fluorouracil and oxaliplatin, indicating a complex relationship between fasting and cancer treatment.
The study identified that fasting induces CRC cells to enter a slow-cycling state, which may lead to the development of drug-tolerant persister cells that contribute to cancer relapse; however, combining fasting with ferroptosis inducers could enhance tumor inhibition and target these resistant cells.
Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells.Liu, X., Peng, S., Tang, G., et al.[2023]

References

Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial. [2021]
Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. [2022]
Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. [2023]
Fasting-mimicking diet: a metabolic approach for the treatment of breast cancer. [2023]
Fasting and fasting mimicking diets in cancer prevention and therapy. [2023]
Intakes of selected nutrients and food groups and risk of ovarian cancer. [2022]
Dietary Practices After Primary Treatment for Ovarian Cancer: A Qualitative Analysis From the OPAL Study. [2022]
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