What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, particularly those involving nutritional support and remote monitoring, such as those studied in the STRONG program, often include chemotherapy and supportive care. Chemotherapy can cause side effects like nausea, vomiting, fatigue, loss of appetite, and increased risk of infections due to lowered white blood cell counts. Nutritional support aims to mitigate some of these side effects by ensuring adequate calorie and nutrient intake, which can help maintain body weight and strength. Remote monitoring can help manage symptoms and side effects more effectively by providing timely interventions and adjustments to the treatment plan.

What prior FDA approvals exist?

FDA approvals for the treatment of pancreatic cancer have included systemic chemotherapy regimens such as FOLFIRINOX and gemcitabine plus nab-paclitaxel, which have shown survival benefits in clinical trials. While these treatments focus on chemotherapy, the STRONG program emphasizes nutritional support and remote monitoring, which are crucial for managing the overall health and quality of life of patients undergoing chemotherapy. Although specific FDA approvals for nutritional support and remote monitoring in pancreatic cancer are not detailed, these supportive care measures are recognized as essential components of comprehensive cancer care.

What other types of research exist?

Promising alternatives to the STRONG program for pancreatic cancer patients include: 1) Anamorelin, a ghrelin mimetic shown to improve appetite and body weight in cancer cachexia patients, 2) Telemedicine platforms that offer comprehensive remote monitoring and personalized nutritional guidance, and 3) Integrative care programs combining telehealth with dietary and psychological support tailored to individual patient needs.

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Supportive Care + Nutritional Counseling for Pancreatic Cancer

N/A

Waitlist Available

Led By Pamela Hodul, MD

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

≥18 years old

Able to speak and read English or Spanish

Must not have

Undergoing concurrent treatment for a second primary GI cancer

Presence of malignant ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program called STRONG that gives nutrition advice and supportive care remotely. It is aimed at people with pancreatic cancer who are receiving chemotherapy. The program helps by offering guidance on what to eat and how to take care of themselves during treatment.

Who is the study for?

Adults over 18 with newly diagnosed or recurrent pancreatic cancer who are starting chemotherapy can join. They must be able to consent, speak English or Spanish, and not have serious psychiatric issues, another GI cancer treatment, poor physical function (ECOG status >2), recent chemo for recurrence, or use tube feeding.

What is being tested?

The STRONG program is being tested for its effectiveness in providing nutritional guidance and supportive care using tools like Fitbit data collection and surveys (Fact G Survey, GAD-7, PHQ-9) to improve the well-being of patients undergoing chemotherapy for pancreatic cancer.

What are the potential side effects?

There may not be direct side effects from the STRONG program itself as it involves non-invasive support measures. However, participants may experience emotional discomfort when discussing their health condition during counseling sessions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can speak and read English or Spanish.

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

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 ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Data Collection - Feasibility

Participant Rating on Ease of Use for the Mobile Application - Usability

Recruitment Rate - Feasibility

Secondary study objectives

Participant Compliance with Dietary Log - Intervention Adherence

Participant Compliance with Dietician Visits - Intervention Adherence

Participant Compliance with Palliative Care Visits - Intervention Adherence

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nutritional SupportExperimental Treatment5 Interventions

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nutrition Counseling

2015

Completed Phase 2

~320

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer include systemic chemotherapy and supportive care. Chemotherapy, such as FOLFIRINOX and gemcitabine plus nab-paclitaxel, works by targeting rapidly dividing cancer cells, thereby slowing tumor growth and alleviating symptoms. Supportive care, including nutritional support and remote monitoring, aims to manage symptoms, improve quality of life, and maintain nutritional status. This is crucial for pancreatic cancer patients who often suffer from cachexia and malnutrition, which can significantly impact their overall health and ability to tolerate treatments. The STRONG program's focus on nutritional support and remote monitoring helps ensure that patients receive continuous care, potentially improving treatment outcomes and quality of life.