Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether fasting for 24 to 48 hours before chemotherapy can help improve the effectiveness of treatment for women with early-stage breast cancer. The goal is to see if this fasting approach can make chemotherapy work better and reduce side effects for patients receiving treatment either before or after surgery.

To participate in the trial, you need to be a woman diagnosed with a certain type of breast cancer (stage I-III) and planning to receive specific chemotherapy treatments. You should also have a body mass index (BMI) of at least 19.5 and be willing to change your diet and provide stool samples during the study. If you meet these criteria and agree to join, you can expect to follow a fasting routine alongside your chemotherapy sessions. It’s important to note that some health conditions and medications may make you ineligible for this trial, so discussing your situation with your doctor is essential.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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