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Fasting Intervention for Ovarian Cancer (FAST Trial)

N/A

Recruiting

Led By Jenna Marcus, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed or high suspicion for endometrial, ovarian, fallopian tube or primary peritoneal cancer, and are able and expecting to undergo adjuvant chemotherapy following hysterectomy for treatment of disease, as determined by their treating physician

ECOG status of 0 or 1

Must not have

Patients who have undergone prior systemic therapy to treat a malignancy in the last 2 years

ECOG status greater than 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate the effects of fasting & ketogenic diets on side effects & quality of life of women with endometrial & ovarian cancer.

Who is the study for?

This trial is for women over 18 with confirmed or suspected endometrial, ovarian, fallopian tube, or primary peritoneal cancer who are fluent in English and have internet access. They must be planning to receive chemotherapy after surgery at Northwestern Medicine and have an ECOG status of 0 or 1.

What is being tested?

The study tests the effects of alternate day fasting on side effects and quality of life during chemotherapy for gynecologic cancers. It aims to see if this diet regimen can reduce the negative impact of standard chemotherapeutic treatment.

What are the potential side effects?

While specific side effects aren't listed for the FAST Intervention, fasting may cause fatigue, dizziness, headaches, low blood sugar levels (hypoglycemia), and could affect how other medications work.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am expected to have chemotherapy after a hysterectomy for my cancer.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer treatment within the last 2 years.

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My physical activity is somewhat limited but I can still take care of myself.

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I do not have diabetes, recent heart attack, stroke, blood clots in lungs, kidney failure, or any condition that prevents fasting.

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I am not planning to have chemotherapy at Northwestern Medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment Compliance

Fasting non-compliance

Treatment Compliance

Secondary study objectives

Adverse events and toxicity

Neuropathic Pain

Physical Function

Other study objectives

Cancer Related Fatigue

Molecular biomarker: Estrone

Molecular biomarker: Insulin

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FAST GroupExperimental Treatment1 Intervention

The FAST intervention will consist of one week of alternate day fasting (ADF) using the sandwich model at the start of each cycle of chemotherapy, for a total of 6 weeks of ADF. Patients will be instructed on how and what they may consume on fasting days.

Group II: Control GroupActive Control1 Intervention

Participants in the control arm will be instructed to eat as desired throughout their entire chemotherapy treatment course. Control group participants will not receive any special study- related instructions or direction regarding food and drinks consumed during chemotherapy.

0 / 6Eligibility criteria met