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2016-01-07
2018-01-15
2022-12-19
21
NCT02432950
City of Hope Medical Center
City of Hope Medical Center
INTERVENTIONAL
Pancreatic Nutritional Program for Weight Loss in Overweight/Obese Patients With Stage I-III Breast Cancer
This pilot clinical trial studies a pancreatic nutritional program for helping patients with stage I-III breast cancer who are overweight or obese lose weight. When patients have a high level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and other illnesses. Breast cancer patients who are overweight and obese are more likely to have their breast cancer return. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low, and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment.
PRIMARY OBJECTIVES: I. To estimate the change in body weight at 6 months post-intervention relative to baseline. SECONDARY OBJECTIVES: I. To examine changes in: body composition; body chemistry; physical fitness; inflammatory markers; deoxyribonucleic acid (DNA) repair capacity; and quality of life per the Functional Assessment of Cancer Therapy - Breast (FACT-B)+4, version 4 questionnaire at 6 months post-intervention relative to baseline. II. To describe adverse events possibly related to wearing the glucometer sensor or following the pancreatic nutritional program (PNP) diet. III. To document compliance with the various components of the PNP (wearing the glucometer sensor; recording body weight; completing journal entries; completing meal cards; attending weekly counseling sessions with diet instructor). OUTLINE: Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Patients also undergo automated glucometry every 15 minutes, review their individual food choices and blood glucose levels 90 minutes after eating, keep a daily nutrition and lifestyle journal log, fill out a daily meal discovery card log, and attend weekly meetings with a diet and lifestyle instructor for 12 weeks. After completion of study, patients are followed up within 1 week and then at 6 months.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-04-29 | N/A | 2023-03-17 |
2015-04-29 | N/A | 2023-03-21 |
2015-05-04 | N/A | 2023-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Supportive care (PNP) Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Pa | DIETARY_SUPPLEMENT: Dietary Intervention
OTHER: Educational Intervention
OTHER: Laboratory Biomarker Analysis
OTHER: Quality-of-Life Assessment
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in body weight | Tested using the paired t-test, alpha = 0.05. | Baseline to 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance) | Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. | Baseline to up to 6 months |
| Change in body composition (BMI) | Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. | Baseline to up to 6 months |
| Change in physical fitness (measured using a handgrip dynamometer) | Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. | Baseline to 6 months |
| Change in quality of life score (FACT-B+4) | Baseline to 6 months | |
| Change in serum inflammatory markers (C-reactive protein; cytokines) | Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. | Baseline to 6 months |
| Compliance metrics (days glucometer sensor not utilized; days body weight not recorded; days journal entries not made; days meal cards not created; weekly counseling sessions missed) | 12 weeks | |
| DNA repair capacity (comet assay's mean olive tail moment; number of gamma-H2A histone family, member X foci) | Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. | Baseline to 6 months |
| Incidence of adverse events reported as possibly or definitely related to wearing the glucometer sensor following the PNP diet | Up to 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
FEMALE
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
