Time-Restricted Eating in Locally Advanced Rectal Cancer: a multi-site, randomized clinical trial of a dietary intervention

Committee/Faculty

Presenting Author(s)

KL

Kevin J. Lee, n/a

MD, PhD
University of Alabama Birmingham
Birmingham, Alabama, United States

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Co-Author(s)

CP

Courtney Peterson

PhD
University of Alabama Birmingham
Birmingham, Alabama, United States

Disclosure: Disclosure information not submitted.
KA

Katelyn Atkins

MD
Cedars Sinai Medical Center
Los Angeles, California, United States

Disclosure: Disclosure information not submitted.
DG

Drew Gunnells

MD
University of Alabama Birmingham
Birmingham, Alabama, United States

Disclosure: Disclosure information not submitted.
MH

Martin Heslin

MD
University of Alabama Birmingham
Birmingham, Alabama, United States

Disclosure: Disclosure information not submitted.
RH

Robert Hollis

MD
University of Alabama Birmingham
Birmingham, Alabama, United States

Disclosure: Disclosure information not submitted.
SS

Sarah Salvy

PhD
Cedars Sinai Medical Center
Los Angeles, California, United States

Disclosure: Disclosure information not submitted.
JF

Jane Figueiredo

PhD
Cedars Sinai Medical Center
Los Angeles, California, United States

Disclosure: Disclosure information not submitted.
JG

Jun Gong

MD
Cedars Sinai Medical Center
Los Angeles, California, United States

Disclosure: Disclosure information not submitted.
KZ

Karen Zaghiyan

MD
Cedars Sinai Medical Center
Los Angeles, California, United States

Disclosure: Disclosure information not submitted.

Purpose: Locally advanced rectal cancer is treated with a neoadjuvant chemotherapy and radiation paradigm followed by surgical resection. In spite of improvements in therapy, local and especially distant failures are not uncommon. Additionally, late treatment toxicities are detrimental to patients’ quality of life. Recent studies in animals suggest that combining intermittent fasting with chemotherapy may improve both treatment success and reduce toxicity. According to the differential stress sensitization theory, dietary interventions such as fasting may decrease insulin-like growth factor (IGF) pathway signaling, which in turn decreases treatment-related toxicities and increases tumor cell sensitivity to chemotherapy and radiation.

Methodology: We are therefore conducting the largest randomized clinical trial of intermittent fasting in active cancer patients. A total of 300 patients with locally advanced rectal cancer who would require neoadjuvant chemoradiation therapy followed by total mesorectal excision will be recruited from Cedars-Sinai Medical Center (Los Angeles, CA) and the University of Alabama at Birmingham’s O’Neal Comprehensive Cancer Center (Birmingham, AL). Patients will be randomly allocated to practice time-restricted eating (8-hour daily eating period, starting 1-3 hours after waking) or eat across a 12-hour or longer period (control group).

Results: Measured outcomes will include pathologic complete response, patient-reported outcomes including quality of life, and the toxicity index. Overall survival and disease-free survival will also be measured. Additionally, the expression of key proteins in both tumor and adjacent normal tissue will be molecularly profiled to identify potential prognostic and predictive signatures and to further elucidate the molecular mechanism of differential stress sensitization.

Conclusions: The results of this trial, which represents the largest dietary intervention trial in patients with cancer to date, will be directly relevant to the thousands of rectal cancer patients diagnosed each year in the United States and internationally who are hopeful that their dietary choices could positively impact their treatment outcome. Exploratory molecular analysis will inform future studies in other tumor types.

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