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Nutrition Support Program for Pancreatic Cancer

N/A

Recruiting

Led By Amir Alishahi Tabriz, MD, PhD, MPH

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planning to initiate chemotherapy under the guidance of Moffitt

Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer

Must not have

Undergoing concurrent treatment for a second primary GI cancer

Presence of malignant ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses how well a program providing additional dietician access and nutrition support helps people living with pancreatic cancer receiving chemo.

Who is the study for?

This trial is for adults over 18 with new or returning pancreatic cancer who are starting chemotherapy. They must be able to understand and speak English, give informed consent, and not have any serious psychiatric issues or other GI cancers.

What is being tested?

The STRONG program's effectiveness is being tested. It includes a daily food diary app, questionnaires, and regular consultations with a dietician to support the nutrition of those undergoing chemo for pancreatic cancer.

What are the potential side effects?

There may not be direct side effects from the interventions as they involve nutritional guidance rather than medication. However, participants might experience stress or discomfort related to frequent monitoring of their diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I plan to start chemotherapy as advised by Moffitt.

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I have been recently diagnosed with advanced or recurrent pancreatic cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for another primary cancer in my digestive system.

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I have fluid buildup due to cancer in my abdomen.

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I need some help with my daily activities.

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I have received chemotherapy for recurrent pancreatic cancer in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the STRONG Program

Feasibility of the STRONG Program

Malnutrition: Low BMI

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Group 2: Usual CareActive Control3 Interventions

Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level.

Group II: Group 1: STRONG InterventionActive Control3 Interventions

The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.

0 / 7Eligibility criteria met