Pancreatic NeoplasmsPanCaxNCT02400398
Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients
An observational study of Pancreatic Neoplasms and Pancreatic Cancer, run by Andrew Hendifar, MD at 1 site in United States.
Trial summary
Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. Patients must be greater than 18 years of age; and have greater than 3 months life expectancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatic Cancer, Cachexia
- What is being tested?
- Tube feeding
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2015to 15 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Pancreatic cancer patients with cachexia receiving enteral feedings by way of gastrojejunal or jejunal tube.
Who may be able to join
- Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy
- Cachexia defined as greater than 5% unexplained weight loss within 6 months prior to screening visit or consultation with medical oncologist
- Candidate for enteral feeding with Peptamen, a peptide based formula. Must have jejunal or gastrojejunal tube either previously placed or at least prior to Day 1 of study
- Age ≥ 18 years.
- ECOG performance status 0-2
- Greater than or equal to 3 month life expectancy
Show all 9Show fewer
- Ability to understand and the willingness to sign a written informed consent
- May have received prior anti-cancer treatment, complete or partial resection of primary tumor
- Patients must be ambulatory and have access to a smart phone to participate in the activity tracker sub-study
Who cannot join
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Malignant ascites requiring paracenteses
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Bowel obstruction, partial or total
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding
Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. Patients must be greater than 18 years of age; and have greater than 3 months life expectancy.
This study will observe a standard of care intervention (tube feeding) for potential benefit. Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the duration of the protocol.
Read the detailed description
In this study, we will prospectively evaluate advanced pancreatic adenocarcinoma patients with cachexia, who are receiving enteral feeding, with a peptide based diet (medical food), through a jejunal or gastrojejunal feeding tube. We plan to collect serum samples routinely and establish a cohort of patients with this clinical syndrome. Our aims are to establish the feasibility and efficacy of enteral nutrition and its relationship to meaningful clinical outcomes. Furthermore, we will assess for a correlation between cachexia, activity, and patient reported outcomes on domains of quality of life in an optional activity tracker sub-study.
- Conditions
- Pancreatic Neoplasms, Pancreatic Cancer, Cachexia, Weight Loss
- Being tested
- Tube feeding
- Medical subject headings
- Pancreatic Neoplasms, Cachexia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube feedingOther
Also called Enteral feeding, Jejunal tube, Gastrojejunal tube
Jejunal or gastrojejunal tube feeds will be given as continuous feeds via pump with Peptamen (medical food), at the patient's home, for the duration of the protocol and as directed by the nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| Tube feeding with peptide-base formula | The peptide-based formula (Peptamen) will be administered through a gastrojejunal or jejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered for three 28-day cycles. Receives: Other: Tube feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: Change from baseline at 3 months
Secondary outcomes (13)
Change in lean body mass
Measured by Dexa Scan
Measured: Change from baseline at 3 months
Performance Status (ECOG)
Measured: Change from baseline at 3 months
Quality of Life (EORTC QLQ-C30)
Measured: Change from baseline at 3 months
Response to nutritional management
Assessment based on tumor biomarkers during enteral feeding period
Measured: Change from baseline at 3 months
Food intake assessment by 24-hour recall
Measured: Change from baseline at 3 months
Smell and taste alteration by questionnaire
Measured: Change from baseline at 3 months
Muscle strength using hand grip strength dynamometer
Measured: Change from baseline at 3 months
Survival
Measured: 3 years
Activity - steps taken
As tracked by Fitbit Charge HR biosensor
Measured: Change from baseline at 3 months
Activity - number of stairs
As tracked by Fitbit Charge HR biosensor
Measured: Change from baseline at 3 months
Activity - sleep duration and interruptions
As tracked by Fitbit Charge HR biosensor
Measured: Change from baseline at 3 months
Activity - heart rate
As tracked by Fitbit Charge HR biosensor
Measured: Change from baseline at 3 months
Changes in microbiome analysis
As measured by stool sample microbiome analysis
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start27 Apr 2015
- Primary completionMar 2019
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Hendifar, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Hendifar, MD, Cedars-Sinai Medical Center
- Investigators
- Andrew Hendifar, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400398
- Sponsor's protocol ID
- IIT2014-03-Hendifar-PNCX1
- Acronym
- PanCax
- Status last verified
- Aug 2020
- First submitted
- 12 Jan 2015
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding
- ClinicalTrials.gov ID
- NCT02400398
- Acronym / sponsor ID
- PanCax / IIT2014-03-Hendifar-PNCX1
- Conditions
- Pancreatic Neoplasms, Pancreatic Cancer, Cachexia, Weight Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Andrew Hendifar, MDUniversity, hospital or other
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 27 Mar 2015 (estimated)
- 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.
Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. Patients must be greater than 18 years of age; and have greater than 3 months life expectancy.
This study will observe a standard of care intervention (tube feeding) for potential benefit. Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the duration of the protocol.
Detailed description
In this study, we will prospectively evaluate advanced pancreatic adenocarcinoma patients with cachexia, who are receiving enteral feeding, with a peptide based diet (medical food), through a jejunal or gastrojejunal feeding tube. We plan to collect serum samples routinely and establish a cohort of patients with this clinical syndrome. Our aims are to establish the feasibility and efficacy of enteral nutrition and its relationship to meaningful clinical outcomes. Furthermore, we will assess for a correlation between cachexia, activity, and patient reported outcomes on domains of quality of life in an optional activity tracker sub-study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tube feeding with peptide-base formula | – | Other: Tube feedingThe peptide-based formula (Peptamen) will be administered through a gastrojejunal or jejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered for three 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer patients with cachexia receiving enteral feedings by way of gastrojejunal or jejunal tube.
Key inclusion criteria (9 listed)
- Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy
- Cachexia defined as greater than 5% unexplained weight loss within 6 months prior to screening visit or consultation with medical oncologist
- Candidate for enteral feeding with Peptamen, a peptide based formula. Must have jejunal or gastrojejunal tube either previously placed or at least prior to Day 1 of study
- Age ≥ 18 years.
- ECOG performance status 0-2
Key exclusion criteria (5 listed)
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Malignant ascites requiring paracenteses
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Bowel obstruction, partial or total
- Pregnancy
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 |
|---|---|---|
| Tube feedingAlso: Enteral feeding, Jejunal tube, Gastrojejunal tubeJejunal or gastrojejunal tube feeds will be given as continuous feeds via pump with Peptamen (medical food), at the patient's home, for the duration of the protocol and as directed by the nutritionist. | Other | Tube feeding with peptide-base formula |
Primary outcome
Weight
Time frame: Change from baseline at 3 months
13 secondary outcomes
Change in lean body mass
Time frame: Change from baseline at 3 months
Performance Status (ECOG)
Time frame: Change from baseline at 3 months
Quality of Life (EORTC QLQ-C30)
Time frame: Change from baseline at 3 months
Response to nutritional management
Time frame: Change from baseline at 3 months
Food intake assessment by 24-hour recall
Time frame: Change from baseline at 3 months
Smell and taste alteration by questionnaire
Time frame: Change from baseline at 3 months
Muscle strength using hand grip strength dynamometer
Time frame: Change from baseline at 3 months
Survival
Time frame: 3 years
Activity - steps taken
Time frame: Change from baseline at 3 months
Activity - number of stairs
Time frame: Change from baseline at 3 months
Activity - sleep duration and interruptions
Time frame: Change from baseline at 3 months
Activity - heart rate
Time frame: Change from baseline at 3 months
Changes in microbiome analysis
Time frame: Change from baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Andrew Hendifar, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Pancreatic Cancer, run by Andrew Hendifar, MD 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 9 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: finished, as of the sponsor's last update on 11 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight (time frame: Change from baseline at 3 months). 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 11 Aug 2020.