Carbohydrate restricted dietary intervention for Breast Cancer

Cedars-Sinai Medical Center, Los Angeles, CA
Breast CancerCarbohydrate restricted dietary intervention - Other
Eligibility

Study Summary

This trial is testing a very low carbohydrate diet to see if it helps with a particular medical treatment.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 6 months

6 months
Changes in HDL
Changes in HbA1c
Changes in LDL
Changes in cholesterol
Changes in fasting glucose
Changes in insulin
Changes in serum estradiol
Body Weight Changes
Mean change in weight

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

No dietary intervention
1 of 2
Dietary intervention
1 of 2

Active Control

Experimental Treatment

6 Total Participants · 2 Treatment Groups

Primary Treatment: Carbohydrate restricted dietary intervention · No Placebo Group · Phase 2

Dietary interventionExperimental Group · 2 Interventions: Carbohydrate restricted dietary intervention, standard of care aromatase inhibitors · Intervention Types: Other, Drug
No dietary intervention
Drug
ActiveComparator Group · 1 Intervention: standard of care aromatase inhibitors · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Farin AmersiLead Sponsor
Farin Amersi, MD5.030 ReviewsPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
5Patient Review
Thorough and personable, this was the best surgical experience I have had to date.

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Has the FDA acknowledged Carbohydrate restricted dietary intervention as an accepted practice?

"Carbohydrate restricted dietary intervention is at a Phase 2, meaning while there is some data supporting safety, none yet supports efficacy. Our team has given it a score of 2." - Anonymous Online Contributor

Unverified Answer

Are patients currently being enrolled in this trial?

"That is correct. As of today, the study detailed on clinicaltrials.gov is still recruiting patients. This research was initially posted on February 4th, 2020 and was most recently updated on June 30th, 2022. In total, 40 individuals are needed for this project taking place at a single site." - Anonymous Online Contributor

Unverified Answer

How many test subjects are required for this clinical trial?

"The correct answer is that this study is actively recruiting patients, as shown by the information on clinicaltrials.gov. This particular trial was first posted on February 4th 2020 and has been updated as recently as June 30th 2022. The research team is looking for 40 people to participate at 1 location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.