← Back to Search

Fasting for Breast Cancer (GAMMER Trial)

N/A
Recruiting
Led By Jennifer Sheng, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) 0-1 (as per recent provider note or direct confirmation with provider)
Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast
Must not have
Serious/uncontrolled medical condition (e.g. end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, history of bariatric surgery)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 years
Awards & highlights

Summary

"This trial aims to see if fasting for 24-48 hours can help make chemotherapy more effective for breast cancer patients before or after surgery."

Who is the study for?
This trial is for individuals undergoing chemotherapy for breast cancer, either before or after surgery. Participants will try water-only fasting for 24-48 hours to see if it helps with the treatment.
What is being tested?
The study is testing whether short-term fasting can make chemotherapy more effective in treating breast cancer. Patients will fast for one to two days during their chemo cycles.
What are the potential side effects?
Potential side effects may include fatigue, weakness, headaches, dizziness from fasting; however, these are not directly related to any medication or intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been diagnosed with stage I-III breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any severe medical conditions like kidney failure, uncontrolled high blood pressure, or liver cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with self-reported adherence to the fasting regimen
Secondary outcome measures
Changes in Key Inflammatory Cytokines/Chemokines
Compare Changes in Tumor Cells
Compare Modulation of Gut Microbiome
+6 more
Other outcome measures
Absolute Percentage Change in Ki-67
Prevalence of AA Genotype

Side effects data

From 2015 Phase 4 trial • 15 Patients • NCT01380366
7%
Hospitalization for Escherichia coli Infection
7%
Hospitalization for Gram-positive Cocci
7%
Hospitalization for positive line infection
7%
Pancreatitis
7%
Hospitalization for abdominal pain (pre-treatment)
7%
Hospitalization for Flu like Symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients Consented to be Given rHGH

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fasting prior to chemotherapyExperimental Treatment1 Intervention
Prior to chemotherapy administration, a trial of a 24-hour water-only fast will be conducted; at least 1 successful 24-hour fast is required to proceed with the fasting intervention during chemotherapy. A total of 3 trials is allowed (for a maximum of 48 hours fasting).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fasting
2019
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
566 Previous Clinical Trials
33,346 Total Patients Enrolled
44 Trials studying Breast Cancer
4,978 Patients Enrolled for Breast Cancer
The Commonwealth FundOTHER
12 Previous Clinical Trials
228,022 Total Patients Enrolled
Maryland Cigarette Restitution FundOTHER_GOV
8 Previous Clinical Trials
827 Total Patients Enrolled
3 Trials studying Breast Cancer
562 Patients Enrolled for Breast Cancer
~20 spots leftby Aug 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top