Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 35 for:    breast cancer weight gain

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02432950
Recruitment Status : Active, not recruiting
First Posted : May 4, 2015
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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.

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Dietary Intervention Other: Educational Intervention Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PANCREATIC NUTRITIONAL PROGRAM (PNP): A Novel Weight Reduction Program in Overweight/Obese Breast Cancer Survivors
Study Start Date : January 7, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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. 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
Participate in the PNP
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Educational Intervention
Participate in the PNP
Other Names:
  • Education for Intervention
  • Intervention, Educational

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Baseline to 6 months ]
    Tested using the paired t-test, alpha = 0.05.


Secondary Outcome Measures :
  1. Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance) [ Time Frame: Baseline to up to 6 months ]
    Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.

  2. Change in body composition (BMI) [ Time Frame: Baseline to up to 6 months ]
    Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.

  3. Change in physical fitness (measured using a handgrip dynamometer) [ Time Frame: Baseline to 6 months ]
    Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.

  4. Change in quality of life score (FACT-B+4) [ Time Frame: Baseline to 6 months ]
  5. Change in serum inflammatory markers (C-reactive protein; cytokines) [ Time Frame: Baseline to 6 months ]
    Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.

  6. 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) [ Time Frame: 12 weeks ]
  7. DNA repair capacity (comet assay's mean olive tail moment; number of gamma-H2A histone family, member X foci) [ Time Frame: Baseline to 6 months ]
    Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.

  8. Incidence of adverse events reported as possibly or definitely related to wearing the glucometer sensor following the PNP diet [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432950


Locations
Layout table for location information
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Joanne Mortimer City of Hope Medical Center

Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02432950     History of Changes
Other Study ID Numbers: 14253
NCI-2015-00654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
14253 ( Other Identifier: City of Hope Medical Center )
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight
Signs and Symptoms