What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, including chemotherapy, radiation, and surgery, often result in a range of side effects. Chemotherapy can cause nausea, vomiting, loss of appetite, weight loss, fatigue, and neuropathy. Radiation therapy may lead to skin irritation, fatigue, and gastrointestinal issues. Surgical interventions can result in pain, fatigue, and digestive complications. Behavioral techniques and nutritional support, as studied in the trial, aim to mitigate these side effects by improving nutritional status and overall quality of life, potentially reducing symptoms like pain, nausea, and weakness.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, primarily focusing on chemotherapy regimens such as FOLFIRINOX (a combination of leucovorin, fluorouracil, irinotecan, and oxaliplatin) and gemcitabine-based therapies, including gemcitabine plus nab-paclitaxel. While these treatments are primarily chemotherapeutic, the trial on Malnutrition Screening and Dietary Intervention highlights the importance of nutritional support and behavioral techniques to improve quality of life. Although specific FDA approvals for behavioral and nutritional interventions in pancreatic cancer are not detailed, these supportive care strategies are recognized as essential components of comprehensive cancer care.

What other types of research exist?

Promising novel alternatives for pancreatic cancer patients include the use of ghrelin and its mimetics, such as anamorelin, which have shown potential in managing cancer-related cachexia by increasing appetite and energy intake. Additionally, integrative medicine practices like the use of melatonin have demonstrated benefits in improving quality of life and potentially enhancing the effects of conventional treatments.

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Dietary Intervention for Pancreatic Cancer

Los Angeles, CA

N/A

Recruiting

Led By ZhaoPing Li

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more

Adults >= 18 years old male or female

Must not have

Ascites requiring paracentesis for symptom improvement

Uncontrolled nausea and vomiting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to after 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial involves checking for poor nutrition and providing personalized diet plans and regular support to patients with pancreatic cancer that cannot be surgically removed. The goal is to improve their quality of life by ensuring they get the right nutrients.

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Who is the study for?

This trial is for adults over 18 with unresectable pancreatic cancer, who are either not on chemotherapy, starting their first cycle, or have been through more than one cycle but still have a life expectancy of over 6 months. They should be able to perform daily activities (Karnofsky score ≥60) and live longer than 3 months.Check my eligibility

What is being tested?

The study tests if screening patients for malnutrition and providing dietary support improves quality of life compared to standard care. It involves best practices in nutrition, medical chart reviews, questionnaires, using medical devices to assess nutrition status, and tailored dietary interventions.See study design

What are the potential side effects?

Since the intervention focuses on nutritional assessment and support rather than medication or invasive procedures, side effects may be minimal. However, changes in diet can sometimes cause digestive discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am expected to live more than 3 months and can care for myself with some assistance.

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I am 18 years old or older.

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Exclusion Criteria

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

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I need a procedure to remove fluid from my abdomen to relieve symptoms.

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I frequently experience severe nausea and vomiting that is not managed by medication.

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My creatinine level is above the normal range.

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I am experiencing pain that my current medication cannot control.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 12 weeks

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

Treatment Details

Study Objectives

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

Primary study objectives

Average daily steps

Calorie intake from Myfitness Pal

Frequency of hospitalizations

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ARM II (Dietary intervention)Experimental Treatment5 Interventions

Patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study.

Group II: ARM I (Standard of care)Active Control4 Interventions

Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.

0 / 6Eligibility 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

Common treatments for pancreatic cancer include chemotherapy, radiation therapy, and targeted therapies. However, for patients with unresectable pancreatic cancer, malnutrition screening and dietary interventions are crucial. These interventions aim to improve nutritional status and quality of life by addressing the severe weight loss and weakness often experienced by these patients. Behavioral techniques help patients modify their reactions to environmental triggers that cause negative reactions, such as nausea and vomiting, while nutritional support provides essential nutrients to combat malnutrition. This approach is vital as it can enhance the patient's overall well-being, potentially improve treatment tolerance, and extend survival.