RECRUITING

Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

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Conditions

Breast CancerEarly-stage Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-08
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06536881

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast
  2. * Planning for standard neoadjuvant or adjuvant chemotherapy ddAC or TC for 4 cycles (concurrent anti-HER2 therapy is permitted)
  3. * Provider physical exam within 4 weeks of consent
  4. * Eastern Cooperative Oncology Group (ECOG) 0-1 (as per recent provider note or direct confirmation with provider)
  5. * BMI ≥ 19.5 kg/m2 (as per most recent visit documented in medical record)
  6. * Willingness to change diet, and provide fecal sample 3 times during study
  1. * BMI \<19.5 kg/m2
  2. * Diabetes
  3. * History of eating disorder
  4. * Serious/uncontrolled medical condition (e.g. end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, history of bariatric surgery)
  5. * Pregnant or nursing
  6. * 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

Contacts and Locations

Study Contact

Jennifer Sheng, MD
CONTACT
202-537-4000
jsheng7@jhmi.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08
Study Completion Date2029-05

Study Record Updates

Study Start Date2024-08-08
Study Completion Date2029-05

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • Early-stage Breast Cancer