Nutrition Coaching for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Pregnancy, Metastatic cancer, Bowel obstruction, Ascites, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if remote nutrition coaching can assist people with pancreatic cancer during chemotherapy. Participants in the experimental group will receive dietary advice every two weeks to address nutrition concerns and follow an anti-inflammatory diet. The trial seeks individuals with newly diagnosed pancreatic tumors who are about to begin chemotherapy. Candidates who can eat by mouth and have no major psychiatric or neurological issues may be suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance nutritional support for future patients.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this remote nutrition coaching and monitoring intervention is safe?

Studies have shown that remote nutrition coaching is generally safe and well-liked by patients. In earlier research, most participants stayed with the program, with 79% tracking their food intake most days and meeting with a dietitian regularly. This suggests that the program is user-friendly and harmless. No serious side effects were reported in these studies. The program focuses on helping patients manage their diet better, which is not known to cause any negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Coaching and Monitoring Intervention for pancreatic cancer because it offers a personalized and proactive approach to patient care. Unlike traditional treatments that focus primarily on medical interventions, this method emphasizes dietary coaching tailored to each patient's needs, aiming to optimize treatment response through nutrition. By focusing on anti-inflammatory diets and setting specific, achievable goals, this approach could improve patients' overall well-being and enhance the effectiveness of conventional treatments. This represents a shift towards integrating lifestyle changes with medical care, potentially leading to better health outcomes for pancreatic cancer patients.

What evidence suggests that this remote nutrition coaching and monitoring intervention is effective for pancreatic cancer?

Research shows that remote nutrition coaching, which participants in this trial may receive, can improve diet and treatment response in people with pancreatic cancer. Studies have found that patients receiving this support often adhere better to anti-inflammatory diets, potentially reducing inflammation and enhancing overall health. Early results suggest that this approach is practical and acceptable to patients, as they are willing to try it and find it easy to manage. While strong evidence on its direct effectiveness for pancreatic cancer is still being gathered, promising results in related areas suggest potential benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Sylvia Crowder, PhD

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 newly diagnosed, non-metastatic pancreatic cancer who are about to start chemotherapy and can eat by mouth. They must be able to understand English and give verbal consent. People with serious mental disorders or those on tube feeding, pregnant women, or patients with bowel obstruction risks cannot join.

Inclusion Criteria

Able to speak and read English

I do not have any mental health conditions that would prevent me from participating.

Able to consume food orally

Exclusion Criteria

Women who are pregnant

I am receiving my nutrition through a feeding tube or IV.

My cancer has spread from the pancreas to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a remote nutrition coaching and monitoring intervention during the 12 weeks of active chemotherapy

12 weeks

Biweekly dietary coaching sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Nutrition Coaching and Monitoring Intervention

Trial Overview The study tests a remote nutrition coaching program during the first 12 weeks of chemotherapy for pancreatic cancer. It includes dietary assessments using questionnaires, educational materials on nutrition, personalized coaching sessions, and follow-up surveys to measure cognitive function and quality of life.

How Is the Trial Designed?

Group I: MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response Experimental Treatment 6 Interventions

Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.

Group II: Standard Usual Care Active Control 5 Interventions

Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.432

Feasibility and acceptability of the MONITOR study The aim of this pilot trial was to examine feasibility, acceptability, usability, and preliminary efficacy of a remote nutrition monitoring ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06050395

The MONITOR Study: Remote Monitoring Of a Nutrition ... The purpose of the study is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910065/

A study protocol for a pilot randomized controlled trial A digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-07988

Remote Monitoring of a Nutrition Intervention to Optimize ... This clinical trial evaluates a remote nutrition coaching and monitoring intervention to optimize treatment response for patients with pancreatic cancer

5. withpower.com withpower.com/trial/phase-malignant-neoplasm-of-pancreas-8-2023-f3894

Nutrition Coaching for Pancreatic Cancer Remote nutrition coaching, including monitoring interventions, has been studied in patients with pancreatic and other gastrointestinal cancers.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8656101/

Pilot trial of remote monitoring to prevent malnutrition after ... Nineteen used the mobile app food diary, 79% of participants recorded food intake for greater than 80% of study days, 95% met with the dietitian ...