Pancreatic Nutritional Program for Weight Loss in Overweight/Obese Patients With Stage I-III Breast Cancer

Obesity Clinical Trial

Official title:

PANCREATIC NUTRITIONAL PROGRAM (PNP): A Novel Weight Reduction Program in Overweight/Obese Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432950
• Other study ID #: 14253
• Secondary ID: NCI-2015-0065414
• Status: Completed
• Phase: N/A
• Start date: January 7, 2016
• Est. completion date: December 19, 2022

Study information

• Verified date: March 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 19, 2022
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with early-stage breast cancer (stage I-III)

• Patients who have or have not undergone chemotherapy are both eligible; if the patient has undergone chemotherapy she must have completed adjuvant chemotherapy for >= 3 months and =< 5 years prior to study enrollment

• Postmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range

• Body mass index (BMI) of 25-33 kg/m^2

• Patients must be willing to adhere to the PNP intervention and the entire 6-month study

• All patients must have the ability and the willingness to sign a written informed consent

Exclusion Criteria:

• Patients who are diabetic

• Patients whose BMI falls outside the eligible range (< 25 kg/m^2 or > 33 kg/m^2)

• Patients with stage IV breast cancer

• Patients with Rheumatoid Arthritis and other inflammatory diseases that would impact correlative studies

Related Conditions & MeSH terms

• Breast Neoplasms
• Obesity
• Overweight
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Intervention

Dietary Supplement:
• Dietary Intervention
Participate in the PNP

Other:
• Educational Intervention
Participate in the PNP
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Tested using the paired t-test, alpha = 0.05.	Baseline to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in quality of life score (FACT-B+4)		Baseline to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of adverse events reported as possibly or definitely related to wearing the glucometer sensor following the PNP diet		Up to 6 months