Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Description

This research is being done to test the feasibility of 24-48 hours of water-only fasting to improve delivery of 4 cycles of chemotherapy in those receiving breast cancer treatment either before or after surgery.

Conditions

Breast Cancer, Early-stage Breast Cancer

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Study Overview

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Study Details

Study overview

This research is being done to test the feasibility of 24-48 hours of water-only fasting to improve delivery of 4 cycles of chemotherapy in those receiving breast cancer treatment either before or after surgery.

Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy

Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Washington

Sibley Memorial Hospital, Washington, District of Columbia, United States, 20016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast
  • * Planning for standard neoadjuvant or adjuvant chemotherapy ddAC or TC for 4 cycles (concurrent anti-HER2 therapy is permitted)
  • * Provider physical exam within 4 weeks of consent
  • * Eastern Cooperative Oncology Group (ECOG) 0-1 (as per recent provider note or direct confirmation with provider)
  • * BMI ≥ 19.5 kg/m2 (as per most recent visit documented in medical record)
  • * Willingness to change diet, and provide fecal sample 3 times during study
  • * BMI \<19.5 kg/m2
  • * Diabetes
  • * History of eating disorder
  • * Serious/uncontrolled medical condition (e.g. end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, history of bariatric surgery)
  • * Pregnant or nursing
  • * Use of medications that must be taken with food: allopurinol, aspirin, amiodarone, baclofen, bromocriptine, carvedilol, carbamezpine, cimetidine, diclofenac, doxycycline, fenofibrate, fludrocortisone, glyburide, hydrocortisone, iron supplements, ketorolac, lithium, methylprednisolone, naproxen, niacin, potassium salts, prednisone, procainamide, sevelamer, sulfasalazine, trazodone, valproic acid

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Jennifer Sheng, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

2029-05