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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00654 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14253 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (PNP) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Dietary Supplement | Participate in the PNP |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Tested using the paired t-test, alpha = 0.05. | Baseline to 6 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Mortimer | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Educational Intervention | Other | Participate in the PNP |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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