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

NCT02432950 | Completed DMC

• 2 other identifiers: 14253NCI-2015-00654
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; 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

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Tested using the paired t-test, alpha = 0.05.

  Baseline to 6 months

Secondary Outcomes (8)

• Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance)

  Baseline to up to 6 months

• Change in body composition (BMI)

  Baseline to up to 6 months

• Change in physical fitness (measured using a handgrip dynamometer)

  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)

  Baseline to 6 months

Study Arms (1)

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.

Dietary Supplement: Dietary Intervention; Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Participate in the PNP

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Supportive care (PNP)

Educational Intervention OTHER

Participate in the PNP

Also known as: Education for Intervention, Intervention, Educational

Supportive care (PNP)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (PNP)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (PNP)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Obesity; Breast Neoplasms

Interventions

Diet Therapy; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Joanne Mortimer

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 4, 2015
• Study Start: January 7, 2016
• Primary Completion: January 15, 2018
• Study Completion: December 19, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

US (1)