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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and satisfaction of a program called STRONG for individuals with pancreatic cancer undergoing chemotherapy. The program provides nutrition counseling (also known as nutrition therapy or dietary counseling) and supportive care through a smartphone app and a Fitbit, which track diet and activity. Individuals newly diagnosed with advanced pancreatic cancer or those whose cancer has returned and are about to start chemotherapy may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to access innovative supportive care tools that may enhance the treatment experience.

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 prior data suggests that the STRONG program is safe for participants with pancreatic cancer?

Research has shown that nutritional counseling is generally safe for people with pancreatic cancer. Studies emphasize the importance of good nutrition in managing symptoms and improving well-being. For example, one review found that nutritional support can address weight loss and poor nutrition, common issues for these patients. Another study noted that early nutrition support can improve quality of life by easing symptoms. Overall, this evidence suggests that nutritional counseling is well-tolerated and can provide significant benefits for those undergoing chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines nutritional counseling with tech-driven support to help manage pancreatic cancer. Unlike traditional treatments that primarily focus on medical interventions, this approach uses wearable sensors and a smartphone app to collect real-time data on a patient's diet and activity. This personalized feedback loop allows dieticians to provide tailored advice, which can improve a patient's quality of life and potentially enhance treatment outcomes. By integrating technology with nutrition, this method offers a new way to support patients beyond standard chemotherapy and surgery.

What evidence suggests that the STRONG program is effective for pancreatic cancer?

Research shows that nutritional counseling can greatly help people with pancreatic cancer manage weight loss and poor nutrition. Studies indicate that up to 80% of patients lose weight at diagnosis, and more than 70% face malnutrition during chemotherapy. In this trial, participants will receive nutritional support from a dietician to address these issues. Patients who receive personalized dietary advice often experience better health and well-being. This approach aims to enhance nutrition and quality of life during challenging treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9101959/

Nutritional Interventions in Pancreatic Cancer This systematic review investigates the impact of nutritional interventions on cachexia, malnutrition and weight loss in patients with pancreatic cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000188

A study protocol for a pilot randomized controlled trial Studies estimate that at diagnosis up to 80% of pancreatic cancer patients report significant weight loss and half of patients are identified as malnourished [[ ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06090916

Malnutrition Screening and Dietary Intervention to Improve ... This clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer ...

4. link.springer.com link.springer.com/article/10.1007/s00520-024-08683-0

Nutritional support in pancreatic cancer patients and its ... Nutritional support by a dedicated dietician is effective in enhancing patients' preoperative nutritional status. However, postoperative ...

5. mdpi.com mdpi.com/2072-6694/15/15/3816

Evaluation of Nutritional Status and the Impact ... Approximately 80% of PC patients report weight loss at diagnosis, and 70.3% of patients develop malnutrition during chemotherapy (CT). Early diagnosis of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425007602

Early supportive and nutritional care for adults with ... Quality of life for individuals with pancreatic cancer is highly influenced by symptom burden and nutritional status. Programs are needed that ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40816695/

Early Supportive and Nutritional Care For Adults With ... Quality of life for individuals with pancreatic cancer is highly influenced by symptom burden and nutritional status. Programs are needed that ...