Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Not Applicable

Recruiting

• Conditions: Breast Cancer; Early-stage Breast Cancer

• Registration Number: NCT06536881
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with self-reported adherence to the fasting regimen

Secondary Outcome Measures

Name	Time	Method
Rate of high-grade adverse effects;Rate of Hematologic Toxicities;Number of Dose Reductions or Dose Delays;Percent Change in Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30 score;Percent change in Functional Assessment of Chronic Illness Therapy-Fatigue Scale;Changes in Key Inflammatory Cytokines/Chemokines;Compare Changes in Tumor Cells;Compare Modulation of Gut Microbiome;Compare the Composition of Gut Microbiome