Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery

Part of paid clinical trials in Cherry Hill, New Jersey.

Sponsor
Thomas Jefferson University
Study ID
NCT05327608
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Invasive Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Short-Term Fasting — OTHER
    Undergo TRE
  • Chemotherapy — DRUG
    Receive standard of care neoadjuvant chemotherapy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index (BMI) 25-40. TRE has been shown to elicit similar metabolic changes as calorie restriction such as reduction in blood glucose levels, improved insulin sensitivity, and reduction of tumor cell growth. TRE may improve outcomes in patients with breast cancer.

Key Dates

First listed
Apr 14, 2022
Start date
Jul 28, 2022
Status verified
Aug 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment (TRE)
    Patients undergo TRE involving 16 hours of fasting and 8 hours of eating for 4 months while undergoing standard of care neoadjuvant chemotherapy. Patients also undergo blood sample collection on study.

Primary Outcome Measure

Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days [ Time Frame: While undergoing neoadjuvant chemotherapy ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Jefferson Cherry Hill HospitalCherry HillNew Jersey08002
Maysa Abu-Khalaf, MD
215-955-8874
Sidney Kimmel Cancer Center Washington Township, , NJ USASewellNew Jersey08080
Maysa Abu-Khalaf, MD
215-955-8874
Jefferson Torresdale HospitalPhiladelphiaPennsylvania19114
Maysa Abu-Khalaf, MD
215-955-8874
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Maysa Abu-Khalaf, MD
[email protected]
215-955-8874
Maysa Abu-Khalaf, MD (PRINCIPAL_INVESTIGATOR)
Asplundh Cancer PavilionWillow GrovePennsylvania19090
Maysa Abu-Khalaf, MD
215-955-8874

Find similar trials in Cherry Hill, NJ

By research site
Jefferson Cherry Hill Hospital· Cherry Hill, NJSidney Kimmel Cancer Center Washington Township, , NJ USA· Sewell, NJJefferson Torresdale Hospital· Philadelphia, PAThomas Jefferson University Hospital· Philadelphia, PAAsplundh Cancer Pavilion· Willow Grove, PA

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