Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming

ConditionsBreast Cancer Early-stage Breast Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

Fasting
Behavioral
The dietician will review the patient's chemotherapy schedule, and confirm the fasting window (as windows may be 24, 26 or 48 hours; and chemotherapy start times can vary from patient to patient).

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Fasting prior to chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Determine the feasibility of water-only fasting during chemotherapy in patients with invasive ESBC receiving cytotoxic chemotherapy.

Time frame

6 -8 months

Secondary outcomes

Rate of high-grade adverse effects

Evaluate the rate of any high-grade adverse effects (severe/very severe) during chemotherapy

Time frame

6-8 months

Rate of Hematologic Toxicities

Evaluate the rate of high-grade hematologic toxicities during chemotherapy

Time frame

6-8 months

Number of Dose Reductions or Dose Delays

Evaluate the total number of dose reductions or delays

Time frame

6-8 months

Percent Change in Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30 score

Participants will complete the Quality of Life Questionnaire C30 The Quality of Life Questionnaire-C30, which includes 30 items. The 30 items assess physical, role, emotional, cognitive and social functioning, global health status or Quality Of Life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. The Quality of Life Questionnaire-C30 is scored on the basis of classical test theory (CTT), and uses the total item score as the scale score. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). The percent change in Patient Reported Outcome scores from baseline is accessed at 6 and 12 months.

Time frame

6 months, 12 months

Other outcomes

Absolute Percentage Change in Ki-67

Compare the absolute percentage change in Ki-67 and pathologic complete response prior to and following neoadjuvant chemotherapy

Time frame

Pre neoadjuvant chemotherapy, post neoadjuvant chemotherapy up to 2 years

Prevalence of AA Genotype

Assess prevalence of AA genotype of MnSOD in patient with early stage breast cancer and if a greater proportion of women with the AA genotype have fewer side effects and improvement in biomarkers after fasting compared to the women who do not.

Time frame

1-2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

The Commonwealth Fund

Collaborator

Maryland Cigarette Restitution Fund

Collaborator

Source ClinicalTrials.gov

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