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ObesityNCT02432950

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

A study testing Dietary Intervention, Educational Intervention and Laboratory Biomarker Analysis in people with Obesity and Stage IA Breast Cancer, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age, women only
What is being tested?
Dietary Intervention, Educational Intervention and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
22 Mar 2016to 19 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the change in body weight at 6 months post-intervention relative to baseline.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Dietary Intervention, Educational Intervention, Laboratory Biomarker Analysis, Quality-of-Life Assessment
Medical subject headings
Obesity, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary InterventionDietary supplement

    Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions

    Participate in the PNP

  • Educational InterventionOther

    Also called Education for Intervention, Intervention, Educational

    Participate in the PNP

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02432950
Study groupRoleWhat they receive
Supportive care (PNP)ExperimentalPatients 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.
Receives: Dietary Supplement: Dietary Intervention; Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

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

    Measured: Baseline to 6 months

Secondary outcomes (8)

  1. 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.

    Measured: Baseline to up to 6 months

  2. Change in body composition (BMI)

    Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.

    Measured: Baseline to up to 6 months

  3. 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.

    Measured: Baseline to 6 months

  4. Change in quality of life score (FACT-B+4)

    Measured: Baseline to 6 months

  5. 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.

    Measured: Baseline to 6 months

  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)

    Measured: 12 weeks

  7. 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.

    Measured: Baseline to 6 months

  8. Incidence of adverse events reported as possibly or definitely related to wearing the glucometer sensor following the PNP diet

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2015 (estimated)
  2. Study start22 Mar 2016
  3. Primary completion15 Jan 2018
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02432950
Sponsor's protocol ID
14253
Other IDs
NCI-2015-00654, 14253
Status last verified
Sep 2026
First submitted
29 Apr 2015
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Intervention, Educational Intervention and Laboratory Biomarker Analysis in people with Obesity and Stage IA Breast Cancer, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02432950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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