Fasting Mimicking Diet for Ovarian Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: L-Nutra Inc
Must not be taking: Daily medications without food
Disqualifiers: Diabetes, Cardiac disease, Food allergies, others
No Placebo Group
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.
12345Is 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.
12345How 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.
12367Eligibility 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.
+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
+4 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
The University of Tennessee Medical CenterKnoxville, TN
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Who Is Running the Clinical Trial?
L-Nutra IncLead Sponsor
University of Tennessee Medical CenterCollaborator
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]In the phase II DIRECT study a fasting mimicking diet (FMD) improved the clinical response to neoadjuvant chemotherapy as compared to a regular diet. Quality of Life (QoL) and illness perceptions regarding the possible side effects of chemotherapy and the FMD were secondary outcomes of the trial.
Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. [2022]Cyclic fasting or calorie-restricted, low-carbohydrate, low-protein diets, collectively referred to as fasting-mimicking diets (FMDs), demonstrated additive or synergistic antitumour effects when combined with chemotherapy, targeted therapies, or immunotherapy in several preclinical in vivo models, including murine models of breast cancer, lung cancer, and colorectal cancer. However, no data on the antitumour efficacy of cyclic FMD in patients with cancer have been published so far. Here, we aim at reporting on patients with advanced cancer achieving complete and long-lasting tumour remissions with cyclic FMD in combination with standard anticancer therapies in the context of the phase Ib NCT03340935 trial.
Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. [2023]More than ten randomized clinical trials are being tested to evaluate the efficacy, effectiveness and safety of a fasting-mimicking diet (FMD) combined with different antitumor agents.
Fasting-mimicking diet: a metabolic approach for the treatment of breast cancer. [2023]Metabolic reprogramming is a new and potentially targetable hallmark of cancer. In recent years, fasting and fasting-mimicking diets (FMDs) have been tested as anticancer strategies both in preclinical experiments and in clinical trials. In this review, we aim at summarizing the available evidence about the antitumour activity of these approaches in preclinical breast cancer models, as well as results from clinical trials investigating fasting/FMD in breast cancer patients.
Fasting and fasting mimicking diets in cancer prevention and therapy. [2023]Fasting mimicking diets (FMDs) are emerging as effective dietary interventions with the potential to improve healthspan and decrease the incidence of cancer and other age-related diseases. Unlike chronic dietary restrictions or water-only fasting, FMDs represent safer and less challenging options for cancer patients. FMD cycles increase protection in healthy cells while sensitizing cancer cells to various therapies, partly by generating complex environments that promote differential stress resistance (DSR) and differential stress sensitization (DSS), respectively. More recent data indicate that FMD cycles enhance the efficacy of a range of drugs targeting different cancers in mice by stimulating antitumor immunity. Here, we report on the effects of FMD cycles on cancer prevention and treatment and the mechanisms implicated in these effects.
Intakes of selected nutrients and food groups and risk of ovarian cancer. [2022]In a hospital-based case-control study, we examined dietary intakes of selected nutrients and food groups and ovarian cancer risk among 496 women with primary, histologically confirmed epithelial ovarian cancer and 1,425 women with nonneoplastic diagnoses, ages 20-87 years, admitted to Roswell Park Cancer Institute between 1982 and 1998. Data on diet and other relevant risk factors in the few years before admission were collected with a self-administered questionnaire. Odds ratios (OR) and 95% confidence intervals (CI) were estimated by unconditional logistic regression adjusting for age, education, region of residence, regularity of menstruation, family history of ovarian cancer, parity, age at menarche, oral contraceptive use, and energy intake. Women in the highest vs. the lowest quartile of total energy had a weak increase in risk (OR = 1.25, 95% CI = 0.90-1.73). Significantly reduced risks were associated with higher intakes of dietary fiber (OR = 0.57, 95% CI = 0.38-0.87), vitamin A (OR = 0.66, 95% CI = 0.45-0.98), carotenoid (OR = 0.64, 95% CI = 0.43-0.93), vitamin E (OR = 0.58, 95% CI = 0.38-0.88), beta-carotene (OR = 0.68, 95% CI = 0.46-0.98), and total fruit and vegetable intake (OR = 0.62, 95% CI = 0.42-0.92). Our findings suggest that a diet high in plant foods may be important in reducing risk of ovarian cancer.
Dietary Practices After Primary Treatment for Ovarian Cancer: A Qualitative Analysis From the OPAL Study. [2022]Little is known about the dietary practices of women who have completed primary treatment for ovarian cancer, many of whom will go on to have cancer recurrence and further treatment. Knowledge of dietary practices is needed to optimize care.