Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to test whether the timing of meals can improve treatment adverse events, influence tumor biology and alter a person's mood and behaviors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Any sex/gender of any ethnic/racial background

• Age greater than or equal to 18 years

• Histologically-confirmed rectal cancer stage II, III, or IV (if curative) or human epidermal growth factor receptor 2-positive (HER2+) or triple negative breast cancer stage I, II, or III (only if definitive intent) per American Joint Committee on Cancer (AJCC) criteria

• BMI 18.5 kg/m2 or greater

• Receiving either neoadjuvant therapy with curative intent (breast cancer patients) or total neoadjuvant therapy with a 5-fluorouracil-based regimen and curative intent (rectal cancer patients)

• Has completed ≤ 4 weeks of neoadjuvant treatment prior to study enrollment

• Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
California
Cedars-Sinai Medical Center
RECRUITING
West Hollywood
Contact Information
Primary
Nathalie Nguyen, MPH
nathalie.nguyen@cshs.org
310.423.4209
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 175
Treatments
Experimental: Time-Restricted Eating (TRE)
8-hour daily eating period. Participants eating window must start within 2 hours of waking up and no later than 9 am.
Active_comparator: Control
More than equal to a 12-hour daily eating period
Related Therapeutic Areas
Sponsors
Collaborators: University of Alabama at Birmingham, National Cancer Institute (NCI), Harvard University
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov