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OpenTrials
Completed

NCT Number: NCT02400398

Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tube feeding

Other

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.

Other names: Enteral feeding, Jejunal tube, Gastrojejunal tube

Primary outcomes

  1. Weight

    Time frame: Change from baseline at 3 months

Secondary outcomes

  1. Change in lean body mass

    Time frame: Change from baseline at 3 months

    Measured by Dexa Scan

  2. Performance Status (ECOG)

    Time frame: Change from baseline at 3 months

  3. Quality of Life (EORTC QLQ-C30)

    Time frame: Change from baseline at 3 months

  4. Response to nutritional management

    Time frame: Change from baseline at 3 months

    Assessment based on tumor biomarkers during enteral feeding period

  5. Food intake assessment by 24-hour recall

    Time frame: Change from baseline at 3 months

  6. Smell and taste alteration by questionnaire

    Time frame: Change from baseline at 3 months

  7. Muscle strength using hand grip strength dynamometer

    Time frame: Change from baseline at 3 months

  8. Survival

    Time frame: 3 years

  9. Activity - steps taken

    Time frame: Change from baseline at 3 months

    As tracked by Fitbit Charge HR biosensor

  10. Activity - number of stairs

    Time frame: Change from baseline at 3 months

    As tracked by Fitbit Charge HR biosensor

  11. Activity - sleep duration and interruptions

    Time frame: Change from baseline at 3 months

    As tracked by Fitbit Charge HR biosensor

  12. Activity - heart rate

    Time frame: Change from baseline at 3 months

    As tracked by Fitbit Charge HR biosensor

  13. Changes in microbiome analysis

    Time frame: Change from baseline at 3 months

    As measured by stool sample microbiome analysis

Sponsors and collaborators

Lead sponsor

Andrew Hendifar, MD

Other

Registry information

Official study title

A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding

Acronym: PanCax

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Mar 27, 2015
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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