Evaluating, Intermittent Fasting, Pancreatic Cancer
Conditions
Brief summary
To learn whether an eating pattern called intermittent fasting (IF) is tolerable and feasible for individuals at high risk of pancreatic cancer and whether IF is associated with changes in biological markers, including metabolic, inflammatory, microbiome, and imaging-related markers.
Detailed description
Primary Objectives • To assess the tolerability and feasibility of Intermittent fasting (IF) in participants at high risk for pancreatic cancer. Secondary Objectives * To assess changes in oral and gut microbiome after IF. * To assess changes in metabolomic markers after IF. * To assess changes in inflammatory markers after IF.
Interventions
OTHERintermittent fasting
They will fast for 16 consecutive hours each day and have an 8-hour window for eating.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants ≥ 18 years old. Participants under 18 are excluded due to their potential inability to understand and consent independently to the methods required for the study drug use and its potential risks and benefits. * Participants evaluated and classified as high risk for pancreatic cancer through a High-Risk Pancreatic Cancer Clinic or High-Risk Pancreatic Cyst Clinic, based on established clinical assessment and risk stratification. * High-risk status may include one or more of the following: * Hereditary cancer syndromes or known pathogenic germline mutations associated with pancreatic cancer risk * Family history of pancreatic ductal adenocarcinoma (PDAC) * Presence of pancreatic cysts or precursor lesions (e.g., IPMN, MCN) * New-onset diabetes mellitus is considered suspicious for pancreatic cancer * History of recurrent or chronic pancreatitis * Eligibility and surveillance risk assessment must be consistent with NCCN (National Comprehensive Cancer Network) Guidelines for Pancreatic Cancer Screening in High- Risk Individuals. * Participants are able to understand and are willing to sign a written informed consent document. * Both English-speaking and non-English-speaking participants are eligible for participation * Participants are willing to make a change in eating time patterns. * Participants are willing to provide App-tracked fasting time data over the course of the study.
Exclusion criteria
* BMI \< 18.5 Kg/m2 * Documented history of symptomatic hypoglycemia * Pregnant or breastfeeding women * Cognitively impaired individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs). | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTFlorencia McAllister, MD
PRINCIPAL_INVESTIGATORFlorencia McAllister, MD
M.D. Anderson Cancer Center
Outcome results
None listed