We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04722341
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04722341
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : April 27, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Alabama at Birmingham
Information provided by (Responsible Party):
Sarah Salvy, Cedars-Sinai Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Behavioral: Time-Restricted Eating (TRE) Behavioral: Control Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Arm Intervention/treatment
Experimental: Time-Restricted Eating (TRE)
8-hour daily eating period, starting 1-3 hours after waking up
Behavioral: Time-Restricted Eating (TRE)
8-hour daily eating period, starting 1-3 hours after waking up

Active Comparator: Control
More than equal to a 12-hour daily eating period
Behavioral: Control
More than equal to a 12-hour daily eating period




Primary Outcome Measures :
  1. Treatment Related Toxicities [ Time Frame: at end of 6 month intervention ]
    Will test to see if the toxicity index is different between the TRE and control groups as measured by the Common Terminology Criteria for Adverse Events (CTCAE). CTCAE includes all AEs and is graded as of 0 (absence of toxicity) to 5 (deceased), where 3 denotes a dose-limiting toxicity (DLT). This composite score accounts for the frequency and cumulative burden of all toxicities during the treatment period.

  2. Patient-reported outcomes (PROs) [ Time Frame: at end of 6 month intervention ]
    average and standard errors of patient-reported outcomes (PROs) as measured by the PRO-CTCAE which includes 78 treatment toxicities that patients can systematically document the frequency, severity (and interference of each toxicity). Descriptive statistics will be presented for both quantitative and qualitative variables, with profile plots showing the average and standard errors of PROs over time.


Secondary Outcome Measures :
  1. Signaling [ Time Frame: at end of 6 month intervention ]
    IGF-1 and its binding proteins-IGFBP-1 and IGFBP-3-will be measured in serum collected in the morning after at least 8 hours of fasting. Descriptive statistics will be performed with IGF-1 and the ratios of IGF-1 to its two binding proteins as the response variables.

  2. Mood [ Time Frame: at end of 6 month intervention ]
    The NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) was developed to standardize assessment of physical, mental, or social health patient-reported outcomes. Each questionnaire includes Likert-scale type questions ranging from 1-5. Total scores are converted to age-standardized T scores, for which normative mean is 50, and standard deviation is 10. The fatigue, pain, anxiety/depression, and physical function scales are validated in the cancer population. NIH PROMIS short forms will be used to assess symptoms of anxiety, depression. We will compare changes in PROMIS scores across study arms and test whether mood moderate relationships between intervention arms and clinical outcomes.

  3. Psychosocial Functioning [ Time Frame: at end of 6 month intervention ]
    Social Adjustment Scale-Self-Report (SAS-SR) assesses both behavioral and emotional social adjustment in the past two weeks across six domains: (1) paid or unpaid work, (2) social and leisure activities, (3) relationships with extended family, (4) role as a marital partner, (5) parental role, and (6) role within the family unit, including perceptions about economic functioning. Each area covers four expressive and instrumental categories: performance at expected tasks; the amount of friction with people; finer aspects of interpersonal relations; and feelings and satisfactions. Each question is rated on a five-point scale from which role area means, and an overall mean can be obtained, with higher scores denoting greater impairment. The instrument has good psychometric properties and is particularly well-tailored to assess whether work, family, and social functioning moderate the relationships between intervention arms and clinical outcomes.

  4. Dietary Intake [ Time Frame: at end of 6 month intervention ]
    will be assessed using interviewer-administered, multi-pass 24h-recalls. Participants will complete three in-person dietary recalls (two weekdays and one weekend day) at each assessment time point. The Nutrition Data System for Research software (NDSR; Nutrition Coordinating Center, University of Minnesota) will be used to analyze participants' dietary intake. We will assess changes in total energy (kcals), Healthy Eating Index (HEI 2015) as well as changes in added sugar, fruits, and vegetables, solid fats, alcoholic beverages, sodium, and fat. We will assess changes in dietary intake across study arms and examine whether these changes moderate the relationships between intervention arms and clinical outcomes.

  5. Physical Activity [ Time Frame: at end of 6 month intervention ]
    Physical activity will be operationalized as mean metabolic equivalent units (METs) per hour and percent of time spent in sedentary, light, moderate, and vigorous activity as assessed by Friedson (2011) algorithms.

  6. Sleep [ Time Frame: at end of 6 month intervention ]
    In accordance with recommendations for measuring sleep, Cole/Kripke scoring algorithms, will be used to determine the number of nighttime awakenings, sleep efficiency, and percent of time awake after sleep onset. The Pittsburgh sleep quality index (PSQI) will be used to assess subjective sleep quality and disturbance. The PSQI is one of the most commonly used self-rated questionnaires to assess sleep quality in clinical and nonclinical populations (5 minutes to complete). We will compare changes in physical activity and sleep (objective and subjective) across study arms and test whether the change in physical activity and sleep moderate the relationships between intervention arms and clinical outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of any ethnic/racial background
  • Age 21 years or older
  • Histologically confirmed rectal cancer stage II or III per AJCC criteria
  • BMI 18.5 kg/m2 or greater
  • Plan to receive either neoadjuvant conventional chemoradiation or total neoadjuvant therapy (TNT) with 5-fluorouracil-based regimens
  • Demonstrate adequate organ and marrow function within two weeks of study treatment initiation
  • Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

Exclusion Criteria:

  • Prior neoadjuvant or adjuvant chemotherapy/radiation <12 months prior to rectal cancer occurrence
  • Allergic reaction to any of the treatment agents
  • Any prior pelvic radiotherapy or chemoradiotherapy
  • Major surgery/open biopsy ≤4 weeks prior to enrollment or minor surgery/core biopsy ≤1 week prior to enrollment
  • Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
  • History of GI perforation ≤12 months prior to enrollment
  • History of malabsorption, uncontrolled vomiting or diarrhea, or other GI-function affecting disease
  • History of predisposing colonic or small bowel disorders with uncontrolled symptoms
  • Receiving any parenteral nutrition or enteral (tube) feeding or using any other nutritional supplement during the study period
  • History of uncontrolled CHF defined as NYHA Class III or greater
  • Uncontrolled hypertension
  • History of bleeding events, bleeding diathesis, arterial thrombotic events (including TIA, CVA, unstable angina requiring intervention, or MI), or clinically significant PAD and ≤6 months prior to enrollment
  • Pre-existing grade ≥3 neuropathy
  • Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment
  • Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
  • Pregnant or breastfeeding
  • Currently perform overnight shift work more than one day/week on average
  • Regularly eat within an <11-hour period each day
  • Will travel more than three time zones away during the study
  • Known psychiatric or substance abuse disorders that would interfere with adhering to the requirements of the trial
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation in the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722341


Contacts
Layout table for location contacts
Contact: Nathalie Nguyen, MPH 310.423.4209 nathalie.nguyen@cshs.org

Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center Recruiting
West Hollywood, California, United States, 90048
Contact: Nathalie Nguyen, MPH         
Sponsors and Collaborators
Cedars-Sinai Medical Center
National Cancer Institute (NCI)
University of Alabama at Birmingham
Layout table for additonal information
Responsible Party: Sarah Salvy, Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04722341    
Other Study ID Numbers: 15494
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases