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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.

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 data supports the effectiveness of this treatment for pancreatic cancer?

Research shows that nutritional support, including consultations with dietitians, can improve nutritional status and potentially enhance survival in pancreatic cancer patients. Similar interventions in lung cancer patients have shown improved satisfaction with nutritional care and positive effects on weight and well-being. ^{1 2 3 4 5}

Is the Nutrition Support Program for Pancreatic Cancer safe for humans?

The research on similar nutrition support programs, like those involving dietary counseling and monitoring, suggests they are generally safe for humans. Studies have shown that these programs are feasible and acceptable, with no significant safety concerns reported. ^{1 2 6 7 8}

How does the Nutrition Support Program for Pancreatic Cancer differ from other treatments?

The Nutrition Support Program for Pancreatic Cancer is unique because it focuses on systematic nutritional assessment and medical nutrition therapy, which is not standardized in current treatments. This approach involves a dedicated nutrition and metabolic support team to address malnutrition, a common issue in pancreatic cancer patients, potentially improving their quality of life and treatment outcomes. ^{1 3 4 9 10}

Research Team

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

References

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

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

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

Early and Intensive Dietary Counseling in Lung Cancer Patients Receiving (Chemo)Radiotherapy-A Pilot Randomized Controlled Trial. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Prognostic impact of early nutritional support in patients affected by locally advanced and metastatic pancreatic ductal adenocarcinoma undergoing chemotherapy. [2019]

5. England 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. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Changes in dietary intake after diagnosis of breast cancer. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Dietary patterns and information needs of colorectal cancer patients post-surgery in Auckland. [2016]

9. 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]

10. 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]