80 Participants Needed

Nutrition Support Program for Pancreatic Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.26789

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.247810

Who Is on the Research Team?

AA

Amir Alishahi Tabriz, MD, PhD, MPH

Principal Investigator

Moffitt Cancer Center

PH

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.
See 1 more

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.
See 3 more

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?
2Treatment groups
Active Control
Group I: Group 2: Usual CareActive Control3 Interventions
Group II: Group 1: STRONG InterventionActive Control3 Interventions

Find a Clinic Near You

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

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.
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.
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.
Nutritional status of patients with locally advanced pancreatic cancer: a pilot study.Ferrucci, LM., Bell, D., Thornton, J., et al.[2021]

Citations

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. [2015]
Early and Intensive Dietary Counseling in Lung Cancer Patients Receiving (Chemo)Radiotherapy-A Pilot Randomized Controlled Trial. [2018]
Nutritional status of patients with locally advanced pancreatic cancer: a pilot study. [2021]
Prognostic impact of early nutritional support in patients affected by locally advanced and metastatic pancreatic ductal adenocarcinoma undergoing chemotherapy. [2019]
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]
Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]
Changes in dietary intake after diagnosis of breast cancer. [2022]
Dietary patterns and information needs of colorectal cancer patients post-surgery in Auckland. [2016]
Results from a UK-wide survey: the nutritional assessment and management of pancreatic resection patients is highly variable. [2022]
Nutritional management of the patient with pancreatic cancer: from the diagnostic and therapeutic pathway to an integrated hospital-territory approach. [2023]
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