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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Remote Nutrition Coaching and Monitoring Intervention for pancreatic cancer?

Research shows that proactive nutrition screening and intervention can improve outcomes for pancreatic cancer patients. Early and appropriate nutritional intervention is crucial to improve the health and recovery of these patients, suggesting that remote nutrition coaching could be beneficial. ^{1 2 3 4 5}

Is remote nutrition coaching safe for humans?

Remote nutrition coaching, including monitoring interventions, has been studied in patients with pancreatic and other gastrointestinal cancers. These studies focus on improving nutrition and managing malnutrition, which is common in these patients, and do not report any specific safety concerns related to the intervention itself. ^{1 4 5 6 7}

How is the Remote Nutrition Coaching and Monitoring Intervention treatment different from other treatments for pancreatic cancer?

This treatment is unique because it involves remote nutrition coaching and monitoring, which helps manage malnutrition—a common issue in pancreatic cancer patients—by providing ongoing dietary support and assessment without the need for in-person visits. This approach is different from traditional treatments that may not focus on continuous nutritional support or use remote technology. ^{1 2 4 5 7}

What is the purpose of this trial?

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 active chemotherapy for borderline resectable and locally advanced pancreatic cancer participants.

Research Team

Sylvia Crowder, PhD

Principal Investigator

Moffitt Cancer Center

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Results from a UK-wide survey: the nutritional assessment and management of pancreatic resection patients is highly variable. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. Italy 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

6. Canada pubmed.ncbi.nlm.nih.gov

Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Pilot trial of remote monitoring to prevent malnutrition after hepatopancreatobiliary surgery. [2021]