Nutrition Support Program for Pancreatic Cancer

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: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new nutrition support program for people with pancreatic cancer undergoing chemotherapy. Participants will use a Fitbit app to track their food intake and consult with a dietician for personalized nutrition advice. The study measures the program's ease of use and participant satisfaction with the support. Individuals with pancreatic cancer who are receiving chemotherapy and can communicate in English may qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve nutritional support for future patients.

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 focuses on nutrition support for those receiving chemotherapy.

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

Research has shown that components of the STRONG program, such as meeting with a dietician, are generally safe for people with pancreatic cancer. For instance, one study found that 70% of participants maintained or improved their nutrition during treatment, which is crucial for health.

Using a daily food diary with a Fitbit app is also manageable. In a trial, 69% to 92% of participants reported satisfaction with this method of tracking their food, indicating it is a straightforward way to monitor nutrition.

Questionnaires, another part of the program, are typically safe as they involve answering questions about health and well-being. Overall, research and participant feedback suggest that the components of the STRONG program are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to supporting pancreatic cancer patients through nutrition. Unlike standard care, which typically involves generalized dietary advice and clinical discretion, this trial offers a structured program that includes personalized consultations with a Moffitt dietician. The innovative use of a Fitbit smartphone app for daily food intake logging and activity tracking adds a technology-driven element, allowing for more precise monitoring and adjustments. By integrating these tools, the trial aims to enhance nutritional support, potentially improving patient outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that better access to dieticians can greatly improve the nutrition of people with pancreatic cancer. These patients often struggle with weight loss and poor nutrition, but the right nutritional support can help manage these problems. One study found that 70% of pancreatic cancer patients maintained or improved their nutritional health during treatment when they received specific support. Using a smartphone app to track their diet has also been helpful, offering both nutritional and emotional support. In this trial, participants in the STRONG Intervention group will consult with a Moffitt dietician and use a food diary app to log their daily intake, aiming to improve patient care and overall quality of life. Meanwhile, participants in the Usual Care group will be referred to dieticians based on clinical discretion and will wear a Fitbit to collect data on activity level. ^{1 3 6 7 8}

Who Is on the Research Team?

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to speak and read English

I plan to start chemotherapy as advised by Moffitt.

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

Exclusion Criteria

Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)

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

I have fluid buildup due to cancer in my abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the STRONG program intervention, including dietician consultations and nutrition support, while wearing a Fitbit to track activity levels.

12 weeks

6 dietician visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of malnutrition and weight loss.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Consultations with Moffitt Dietician
• Daily Food Intake Diary with Fitbit Smartphone application
• Questionnaires

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 2: Usual Care Active Control 3 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 Intervention Active Control 3 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.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Pancreatic Cancer Action Network

Collaborator

Trials

6

Recruited

10,000+

Published Research Related to This Trial

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]

A survey of 26 hepatopancreatobiliary (HPB) units in the UK revealed that while 88.5% provide a specialist dietetic service, practices for nutritional management in pancreatic cancer patients are inconsistent, highlighting a need for standardized guidelines.

Only 50% of units routinely perform nutrition risk screening, and there is significant variability in the use of nutritional supplements and pancreatic exocrine replacement therapy (PERT), indicating that more robust studies are necessary to establish effective consensus practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a UK-wide survey: the nutritional assessment and management of pancreatic resection patients is highly variable. Russell, TB., Murphy, P., Tanase, A., et al.[2022]

A study involving 30 colorectal cancer patients in Auckland revealed that many did not meet the Ministry of Health's dietary guidelines for fruit and vegetable intake, with only 67% and 50% meeting the recommended servings, respectively.

Over 50% of participants reported not receiving any dietary information after their surgery, indicating a significant unmet need for dietary guidance in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and information needs of colorectal cancer patients post-surgery in Auckland. Cha, R., Murray, MJ., Thompson, J., et al.[2016]

In a study of 38 patients with unresectable pancreatic cancer undergoing chemotherapy, 34.2% were found to have moderate or severe malnutrition, highlighting the importance of nutritional status during treatment.

Patients who survived had a significantly higher protein intake (1.4 g/kg/day) compared to those who did not survive (0.9 g/kg/day) one month after starting chemotherapy, with low protein intake identified as an independent poor prognostic factor, suggesting that improving dietary protein could enhance survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein intake after the initiation of chemotherapy is an independent prognostic factor for overall survival in patients with unresectable pancreatic cancer: A prospective cohort study. Hasegawa, Y., Ijichi, H., Saito, K., et al.[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]

After being diagnosed with breast cancer, women showed small but significant decreases in total energy and macronutrient intake over two years, particularly among younger women.

Despite these changes, there was no significant increase in fruit and vegetable servings, indicating a need for more efforts to encourage healthier dietary habits post-diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in dietary intake after diagnosis of breast cancer. Wayne, SJ., Lopez, ST., Butler, LM., et al.[2022]

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]

Pancreatic cancer patients are at a high risk of malnutrition, which negatively impacts their prognosis and treatment outcomes, highlighting the need for early nutritional intervention.

The Mini Nutritional Assessment is an effective tool for identifying malnourished patients, and there is a call for standardized protocols and better access to clinical nutrition services to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional management of the patient with pancreatic cancer: from the diagnostic and therapeutic pathway to an integrated hospital-territory approach. Gebbia, V., Cuggino, R., Spada, M., et al.[2023]

This pilot study involving 24 lung cancer patients showed that an intensive nutrition intervention during and after radiotherapy was feasible and well-accepted, with a consent rate of 57% and full compliance in completing questionnaires.

Patients receiving the nutrition intervention reported greater satisfaction and showed clinically important improvements in weight, fat-free mass, and both physical and functional well-being, suggesting potential benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and Intensive Dietary Counseling in Lung Cancer Patients Receiving (Chemo)Radiotherapy-A Pilot Randomized Controlled Trial. Kiss, N., Isenring, E., Gough, K., et al.[2018]

In a study of 109 patients with pancreatic ductal adenocarcinoma (PDAC), 64.2% were found to be at high risk of malnutrition, highlighting the importance of nutritional assessment in this population.

Early nutritional intervention within 3 months of diagnosis was associated with significant benefits, including a 2-year overall survival rate of 50.3% for those who gained weight, compared to 33.0% for those who did not, suggesting that timely dietary support can improve outcomes in patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic impact of early nutritional support in patients affected by locally advanced and metastatic pancreatic ductal adenocarcinoma undergoing chemotherapy. Trestini, I., Carbognin, L., Sperduti, I., et al.[2019]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00137

Support through Remote Observation and Nutrition ... The STRONG program provides enhanced dietician access and nutrition support for patients living with pancreatic cancer. The STRONG program may be more ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05438927

Early Supportive Care and Nutritional Support in Adults ... The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy. Official Title. Early ...

3. 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 ...

4. moffitt.org moffitt.org/clinical-trials-and-studies/clinical-trial-22476/

Clinical Trial 22476 The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery. Objective ...

5. 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 [[ ...

6. moffitt.org moffitt.org/about-moffitt/outcomes/pancreatic-cancer/

Pancreatic Cancer Outcomes On average, Moffitt's pancreatic cancer survival rates exceed four times the national average. Learn more about pancreatic cancer survival rates here.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05675059

Study Details | NCT05675059 | Support Through Remote ... The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy. ... Behavioral ...

8. withpower.com withpower.com/trial/phase-pancreatic-neoplasms-11-2022-9b49b

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