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Hormone Therapy

Ketogenic Diet + Letrozole for Breast Cancer

Phase < 1
Waitlist Available
Led By Brent Rexer, MD, PhD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The primary tumor size must be at least 2 mm in size.
Patients must have clinical stage I, II, or III invasive mammary carcinoma planning to undergo surgical treatment with either segmental resection or total mastectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 weeks of a ketogenic diet
Awards & highlights

Study Summary

This trial is testing if a low-carb, high-fat diet may help treat early stage breast cancer in combination with the drug letrozole.

Who is the study for?
This trial is for post-menopausal women with a BMI of 30 or higher, diagnosed with early stage operable ER+ and HER2- breast cancer. They must have adequate organ function, no severe uncontrolled conditions affecting nutrient absorption, not be on insulin for diabetes, and cannot be undergoing other cancer treatments or participating in another neoadjuvant clinical trial.Check my eligibility
What is being tested?
The study tests the combination of a very low carbohydrate ketogenic diet for two weeks with letrozole medication to see how well patients tolerate it and its effect on PI3K signaling pathways in estrogen receptor-positive breast cancer.See study design
What are the potential side effects?
Potential side effects may include those associated with a ketogenic diet such as fatigue, headache, dizziness, constipation, nutrient deficiencies and those related to Letrozole like hot flashes, joint pain, weakness and bone thinning over long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My primary tumor is at least 2 mm big.
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I have stage I, II, or III breast cancer and plan to have surgery.
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My breast cancer has been confirmed by tissue analysis.
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My kidney, liver, and blood tests are within the required ranges.
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My tumor is estrogen receptor positive.
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My tumor does not have the HER2 protein.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 2 weeks of a ketogenic diet
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 2 weeks of a ketogenic diet for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patients who complete the dietary intervention
Secondary outcome measures
Measure changes in body composition
Measure changes in insulin resistance
Measure enhanced inhibition of cancer cell proliferation
+1 more

Side effects data

From 2020 Phase 3 trial • 502 Patients • NCT03096847
46%
NEUTROPENIA
43%
NAUSEA
38%
FATIGUE
33%
ALOPECIA
25%
NASOPHARYNGITIS
20%
LEUKOPENIA
20%
DIARRHOEA
20%
ASPARTATE AMINOTRANSFERASE INCREASED
19%
ARTHRALGIA
19%
ALANINE AMINOTRANSFERASE INCREASED
18%
CONSTIPATION
18%
ANAEMIA
17%
HEADACHE
17%
VOMITING
15%
NEUTROPHIL COUNT DECREASED
15%
STOMATITIS
14%
INSOMNIA
13%
PAIN IN EXTREMITY
13%
BACK PAIN
13%
DYSPNOEA
12%
HOT FLUSH
11%
THROMBOCYTOPENIA
11%
RASH
11%
OEDEMA PERIPHERAL
11%
DECREASED APPETITE
10%
URINARY TRACT INFECTION
10%
WHITE BLOOD CELL COUNT DECREASED
10%
COUGH
10%
PRURITUS
8%
ELECTROCARDIOGRAM QT PROLONGED
8%
DYSPEPSIA
8%
VERTIGO
8%
MUSCULOSKELETAL PAIN
8%
DRY SKIN
8%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
6%
LACRIMATION INCREASED
6%
ABDOMINAL PAIN UPPER
6%
WEIGHT DECREASED
6%
ABDOMINAL PAIN
6%
PYREXIA
6%
BLOOD CREATININE INCREASED
6%
BONE PAIN
6%
DRY MOUTH
6%
ERYTHEMA
5%
DRY EYE
5%
DIZZINESS
4%
HYPERTENSION
4%
MYALGIA
4%
CYSTITIS
4%
DYSGEUSIA
4%
DEPRESSION
4%
SLEEP DISORDER
3%
GENERAL PHYSICAL HEALTH DETERIORATION
3%
BRONCHITIS
3%
MUSCULOSKELETAL CHEST PAIN
3%
POLYNEUROPATHY
2%
SEASONAL ALLERGY
2%
PLEURAL EFFUSION
2%
HYPOCALCAEMIA
1%
INFLUENZA
1%
OROPHARYNGEAL PAIN
1%
METASTASES TO SPINE
1%
SKIN ULCER
1%
GASTROINTESTINAL INFECTION
1%
URETEROLITHIASIS
1%
DEVICE RELATED INFECTION
1%
ARTHROPOD BITE
1%
CHEST PAIN
1%
CYSTITIS ESCHERICHIA
1%
SEPSIS
1%
INCISIONAL HERNIA
1%
COLON CANCER
1%
METASTASES TO BONE
1%
PULMONARY EMBOLISM
1%
ATRIAL FIBRILLATION
1%
ANAL HAEMORRHAGE
1%
HELICOBACTER GASTRITIS
1%
TUMOUR LYSIS SYNDROME
1%
TUMOUR PAIN
1%
WEIGHT INCREASED
1%
PANIC ATTACK
1%
FLANK PAIN
1%
SPINAL PAIN
1%
FEBRILE NEUTROPENIA
1%
CARDIAC FAILURE
1%
ILEUS
1%
INTESTINAL STRANGULATION
1%
COMPLICATION OF DEVICE INSERTION
1%
IMPAIRED HEALING
1%
PAIN
1%
HEPATIC CIRRHOSIS
1%
ABSCESS JAW
1%
APPENDICITIS
1%
MASTITIS
1%
PNEUMONIA
1%
HIP FRACTURE
1%
JAW FRACTURE
1%
RADIUS FRACTURE
1%
BLOOD BILIRUBIN INCREASED
1%
HYPERCALCAEMIA
1%
HYPERKALAEMIA
1%
DEVICE LOOSENING
1%
RENAL FAILURE
1%
RENAL IMPAIRMENT
1%
CIRCULATORY COLLAPSE
1%
TOOTHACHE
1%
BLOOD LACTATE DEHYDROGENASE INCREASED
1%
HYPOAESTHESIA
1%
HYPERFIBRINOLYSIS
1%
DRUG-INDUCED LIVER INJURY
1%
ABDOMINAL PAIN LOWER
1%
DEHYDRATION
1%
OSTEITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ribociclib + Letrozole Cohort B2
Ribociclib + Letrozole Cohort A
Ribociclib + Letrozole Cohort B1
Total
Ribociclib + Letrozole Cohort B

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2-Week Ketogenic DietExperimental Treatment2 Interventions
2-Week Ketogenic Diet in Combination with Letrozole
Group II: Letrozole ControlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,902 Total Patients Enrolled
28 Trials studying Breast Cancer
6,594 Patients Enrolled for Breast Cancer
Brent Rexer, MD, PhD3.52 ReviewsPrincipal Investigator - Vanderbilt Medical Center
Vanderbilt-Ingram Cancer Center
1 Previous Clinical Trials
35 Total Patients Enrolled
2Patient Review
At my first appointment with Dr. Rexer, he seemed to understand the material. We discussed estrogen blockers, and he said that if I had trouble after a few months on one, he would switch me to another. However, he then said that if I had trouble right away, he wouldn’t buy it — implying that all women’s bodies work alike, and so if I had trouble it could only mean I was trying to get away with something. My husband and I were stunned. I understand that anti-cancer drugs are harsh, but I need any doctor I use to treat me as an individual with compassion.

Media Library

Letrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03962647 — Phase < 1
Breast Cancer Research Study Groups: 2-Week Ketogenic Diet, Letrozole Control
Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT03962647 — Phase < 1
Letrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03962647 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When is a 2-Week Ketogenic Diet usually recommended for patients?

"The 2-Week Ketogenic Diet is a popular treatment for breast cancer and has additionally been found to lessen the symptoms of anovulatory cycle, tamoxifen, and postmenopause."

Answered by AI

Is there currently an opportunity for participants to join this research project?

"Data hosted on clinicaltrials.gov attests to the fact that this experiment is actively enrolling participants, having first been registered on July 8th 2019 and lastly edited upon September 20th 2022."

Answered by AI

What is the aggregate size of this research project's participants?

"Affirmative. Clinicaltrials.gov reveals that this experiment, which was initially advertised on July 8th 2019, is presently searching for volunteers to participate. 36 people are needed from one medical centre."

Answered by AI

Is there any precedent for the efficacy of a two-week ketogenic diet?

"Presently, 154 trials are running to observe the effects of a 2-Week Ketogenic Diet, with 39 in their final Phase 3. San Francisco is at the epicenter for this medical research; however, it can be found across 10968 locations worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer
Brent Rexer 2019. "A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03962647.
~0 spots leftby May 2024
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