Supportive Care + Nutritional Counseling for Pancreatic Cancer

Overseen By Emma Hume

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Psychiatric disorders, Substance abuse, GI cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Supportive Care + Nutritional Counseling for Pancreatic Cancer?

Research shows that proactive nutrition screening and intervention can improve outcomes for pancreatic cancer patients. Additionally, personalized nutrition support, including dietitian consultations and self-monitoring, leads to better dietary changes, which can enhance overall well-being and reduce complications. ^{1 2 3 4 5}

Is nutritional counseling safe for humans?

The studies reviewed indicate that nutritional counseling, including the use of technology-assisted tools for dietary monitoring and feedback, is generally safe for humans. Participants in these studies did not report any adverse effects related to the counseling or the use of dietary assessment tools. ^{3 6 7 8 9}

How does the treatment of supportive care and nutritional counseling for pancreatic cancer differ from other treatments?

This treatment is unique because it combines supportive care with personalized nutritional counseling, which can improve nutritional status and quality of life for pancreatic cancer patients. Unlike standard treatments that focus solely on chemotherapy or surgery, this approach emphasizes the importance of nutrition in managing the disease. ^{1 3 4 5 10}

Research Team

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Able to provide informed consent

I can speak and read English or Spanish.

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

Exclusion Criteria

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

I have fluid buildup due to cancer in my abdomen.

You are receiving nutrition through a tube or intravenously.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nutritional Support

Participants receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smartphone app and wearable sensor

12 weeks

Bi-weekly telehealth visits

Chemotherapy

Participants receive chemotherapy while participating in the STRONG program

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fitbit Data Collection
• Nutrition Counseling

Trial Overview 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.

Participant Groups

Group I: Nutritional Support Experimental Treatment 5 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

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Canopy Cancer Collective

Collaborator

Trials

2

Recruited

70+

Findings from Research

In a study of 97 patients with pancreatic adenocarcinoma, systematic malnutrition screening revealed that 74.2% requested referrals to an oncology dietitian, highlighting the need for proactive nutrition interventions.

Attendance at pre-clinic information sessions significantly increased the likelihood of patients requesting referrals and attending dietitian appointments, suggesting that educational initiatives can enhance patient engagement with nutrition services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the nutrition referral system in a multidisciplinary pancreatic cancer clinic. Wong, SC., Reddy, AV., Hacker-Prietz, A., et al.[2023]

Patients with pancreatic cancer often experience significant weight loss and nutritional issues due to the disease's effects on digestion and treatment side effects.

Implementing standardized nutritional assessments and interventions early can help identify and manage nutritional risks, leading to fewer complications, shorter hospital stays, and improved overall well-being for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive nutritional management of the patient with pancreatic cancer. Ottery, F.[2005]

A study with 50 participants showed that high personalization in nutrition support, which included video calls with a dietitian and dietary self-monitoring, led to significantly greater improvements in diet quality compared to low personalization using only a web-based report.

Participants in the high personalization group experienced notable dietary changes, including increased intake of healthy foods and reduced consumption of energy-dense, nutrient-poor foods, highlighting the effectiveness of combining technology with personalized dietary advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. Rollo, ME., Haslam, RL., Collins, CE.[2021]

In a study of 304 pancreatic cancer patients, 70% maintained or improved their nutritional status during treatment, which is crucial for their overall health.

Improvement in nutritional status, as measured by the Subjective Global Assessment (SGA), was linked to a significantly lower risk of mortality, with patients showing improved SGA having a 1.5 times lower risk of death compared to those with deteriorated SGA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. Vashi, P., Popiel, B., Lammersfeld, C., et al.[2015]

In a study of 14 patients with locally advanced pancreatic cancer undergoing chemoradiotherapy, there was a significant improvement in appetite and weight concerns, as measured by the Anorexia/Cachexia Subscale (A/CS), after 6 weeks of treatment.

Weight loss greater than 5% in the first month was linked to higher A/CS scores at 6 weeks, suggesting that maintaining nutritional status may be crucial for improving quality of life in these patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional status of patients with locally advanced pancreatic cancer: a pilot study. Ferrucci, LM., Bell, D., Thornton, J., et al.[2021]

The 'myfood24 Healthcare' app was found to be acceptable for both patients and healthcare professionals in a feasibility study involving 48 participants from weight management and gastroenterology surgery programs.

Compliance with the app was reasonable, with 50% of users recording their dietary intake for four or more days, indicating potential for effective dietary monitoring and support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. Threapleton, DE., Beer, SL., Foley, DJ., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of the nutrition referral system in a multidisciplinary pancreatic cancer clinic. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Supportive nutritional management of the patient with pancreatic cancer. [2005]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

Nutritional status of patients with locally advanced pancreatic cancer: a pilot study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A computerized quantitative food frequency analysis for the clinical setting: use in documentation and counseling. [2008]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

CD-ROM nutrient analysis database assists self-monitoring behavior of active duty Air Force personnel receiving nutrition counseling for weight loss. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Computerized dietary analysis by food groups and by nutrients from food groups. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

NUTRISCORE: A new nutritional screening tool for oncological outpatients. [2022]