Stage III Pancreatic CancerNCT06090916
Malnutrition Screening and Dietary Intervention to Improve Nutrition Outcomes in Patients With Unresectable Pancreatic Cancer
A study testing Best Practice, Dietary Intervention and Medical Chart Review in people with Stage III Pancreatic Cancer and Pancreatic Adenocarcinoma Non-resectable, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer that cannot be removed by surgery (unresectable). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Pancreatic Cancer, Pancreatic Adenocarcinoma Non-resectable
- What is being tested?
- Best Practice, Dietary Intervention and Medical Chart Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy, 2) 1st cycle of chemotherapy, or 3) greater than 1 cycle of chemotherapy if the patient's prognosis is greater than 6 months as determined by oncology collaborators
- Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more
- Adults >= 18 years old male or female
Who cannot join
- Ascites requiring paracentesis for symptom improvement
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than 5 times the upper limit of normal
- Creatinine value greater than 2.0 for men and 1.5 for women
- Uncontrolled pain
- Uncontrolled nausea and vomiting
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Malnutrition Screening and Nutrition Optimization to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
This clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer that cannot be removed by surgery (unresectable). Fewer than 20% of patients diagnosed with unresectable pancreatic cancer do not survive one year after diagnosis so treatment often focuses on improving quality of life. Many patients experience increasing pain, nausea, vomiting, loss of appetite, weight loss and weakness. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Screening for inadequate nutrition (malnutrition) and providing weekly nutritional support may be effective methods to improve nutritional status and improve overall quality of life for patients with unresectable pancreatic cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the quality of life of subjects after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care.
II. To compare the frequency of hospitalization and length of stay (LOS) after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care.
III. To compare the subject's functional status, body weight and dietary intake after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.
ARM II: Patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study.
- Being tested
- Best Practice, Dietary Intervention, Medical Chart Review, Medical Device Usage and Evaluation, Nutritional Assessment
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard nutrition care
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Participate in weekly support sessions with diet prescription
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
Medical Device Usage and EvaluationOther
Record dietary and physical activity using MyFitnessPal smartphone app
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Undergo malnutrition screening
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| ARM I (Standard of care) | Active comparator | Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study. Receives: Other: Best Practice; Other: Medical Chart Review; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration |
| ARM II (Dietary intervention) | Experimental | Patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study. Receives: Other: Dietary Intervention; Other: Medical Chart Review; Other: Medical Device Usage and Evaluation; Other: Nutritional Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured comparing changes in outcomes between study arms
Measured using short form 36. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Measured: After 12 weeks
Frequency of hospitalizations
Hospitalization defined as any stay in the hospital > 24 hours. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Measured: After 12 weeks
Length of hospital stay
Length of stay determined by the number of days of hospitalization including the date of admission and not including the day of discharge from the hospital. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Measured: After 12 weeks
Functional status using Karnofsky performance score
The Karnofsky Performance Status (KPS) is a standardized measure used to assess a patient's ability to perform everyday tasks. It ranges from 0 to 100, with higher scores indicating better function.
Measured: After 12 weeks
Percent change in body weight
Collected from patient medical record. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Measured: Baseline to after 12 weeks
Average daily steps
Daily steps recorded using MyfitnessPal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Measured: After 12 weeks
Calorie intake from Myfitness Pal
Food intake collected every 4 weeks and uploaded into patients medical record via patient portal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start17 Jan 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Silicon Valley Community Foundation
- Responsible party
- Sponsor
- Investigators
- ZhaoPing Li, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090916
- Sponsor's protocol ID
- 22-000208
- Other IDs
- NCI-2023-01097
- Status last verified
- May 2026
- First submitted
- 13 Oct 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition Screening and Nutrition Optimization to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06090916
- Acronym / sponsor ID
- 22-000208
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Silicon Valley Community Foundation
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer that cannot be removed by surgery (unresectable). Fewer than 20% of patients diagnosed with unresectable pancreatic cancer do not survive one year after diagnosis so treatment often focuses on improving quality of life. Many patients experience increasing pain, nausea, vomiting, loss of appetite, weight loss and weakness. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Screening for inadequate nutrition (malnutrition) and providing weekly nutritional support may be effective methods to improve nutritional status and improve overall quality of life for patients with unresectable pancreatic cancer.
Detailed description
PRIMARY OBJECTIVES:
- To compare the quality of life of subjects after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care.
II. To compare the frequency of hospitalization and length of stay (LOS) after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care.
III. To compare the subject's functional status, body weight and dietary intake after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.
ARM II: Patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (Standard of care) | Active comparator | Other: Best Practice, Other: Medical Chart Review, Other: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study. |
| ARM II (Dietary intervention) | Experimental | Other: Dietary Intervention, Other: Medical Chart Review, Other: Medical Device Usage and Evaluation, Other: Nutritional Assessment, Other: Questionnaire AdministrationPatients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy, 2) 1st cycle of chemotherapy, or 3) greater than 1 cycle of chemotherapy if the patient's prognosis is greater than 6 months as determined by oncology collaborators
- Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more
- Adults >= 18 years old male or female
Key exclusion criteria (5 listed)
- Ascites requiring paracentesis for symptom improvement
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than 5 times the upper limit of normal
- Creatinine value greater than 2.0 for men and 1.5 for women
- Uncontrolled pain
- Uncontrolled nausea and vomiting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard nutrition care | Other | ARM I (Standard of care) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsParticipate in weekly support sessions with diet prescription | Other | ARM II (Dietary intervention) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | ARM I (Standard of care), ARM II (Dietary intervention) |
| Medical Device Usage and EvaluationRecord dietary and physical activity using MyFitnessPal smartphone app | Other | ARM I (Standard of care), ARM II (Dietary intervention) |
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingUndergo malnutrition screening | Other | ARM II (Dietary intervention) |
| Questionnaire AdministrationAncillary studies | Other | ARM I (Standard of care), ARM II (Dietary intervention) |
Primary outcome
Quality of life measured comparing changes in outcomes between study arms
Time frame: After 12 weeks
Measured using short form 36. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Frequency of hospitalizations
Time frame: After 12 weeks
Hospitalization defined as any stay in the hospital > 24 hours. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Length of hospital stay
Time frame: After 12 weeks
Length of stay determined by the number of days of hospitalization including the date of admission and not including the day of discharge from the hospital. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Functional status using Karnofsky performance score
Time frame: After 12 weeks
The Karnofsky Performance Status (KPS) is a standardized measure used to assess a patient's ability to perform everyday tasks. It ranges from 0 to 100, with higher scores indicating better function.
Percent change in body weight
Time frame: Baseline to after 12 weeks
Collected from patient medical record. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Average daily steps
Time frame: After 12 weeks
Daily steps recorded using MyfitnessPal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Calorie intake from Myfitness Pal
Time frame: After 12 weeks
Food intake collected every 4 weeks and uploaded into patients medical record via patient portal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZhaoPing Li principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Dietary Intervention and Medical Chart Review in people with Stage III Pancreatic Cancer and Pancreatic Adenocarcinoma Non-resectable, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured comparing changes in outcomes between study arms (time frame: After 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.