The Role of Muscle Cachexia in Pancreatic Cancer

NCT02515513 | Withdrawn

• 2 other identifiers: IRB201500239 - N2R01AR060209-06A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The relationship between myopenia, nutritional status, and long-term oncologic outcomes remains poorly characterized in patients with anatomically resectable pancreatic cancer (PC). The investigators want to look at muscle properties in pancreatic cancer patients to determine possible therapeutic options toward better nutritional status. Patients with benign right upper quadrant pathology will be utilized as controls for the study. The researchers hypothesize that improving cancer cachexia in PC will improve the quality of life and ultimately increase overall survival. The long term goal of is to identify areas of intervention to prevent and/or improve cachectic events in PC in order to significantly improve clinical outcomes. The first step in this long term goal is to fully characterize cachexia in the condition of PC. This research is to understand and modify the local response within skeletal muscle leading to a clinically relevant persistent wasting and to understand and interrupt the systemic stimulus produced by the tumor local environment resulting in these muscle specific mechanisms.

Conditions

Pancreas Cancer

Keywords

Pancreas; Pancreas Cancer; Muscle Biopsy; Cachexia; Muscle Cachexia

Outcome Measures

Primary Outcomes (3)

• Ultrastructural abnormalities in muscle tissue samples between the groups

  To look at the extent of ultrastructural abnormalities in the skeletal muscle by histologic examination of muscle biopsies

  day 1

• Myofiber atrophy in muscle tissue samples between the groups

  2\) identify the growth and atrophy-related transcription factors associated with the muscle pathology and 3) identify the genome-wide gene networks and biological process associated with skeletal muscle pathology in surgically resected PC patients and healthy control patients by RT-PCR and histologic staining of tissues for transcriptional factors associated with cachexia.

  day 1

• Identify gene networks within the skeletal muscle between the groups

  RT-PCR of RNA from biopsied muscle tissues

  day 1

Secondary Outcomes (7)

• History of weight lost

  Baseline

• Nutritional status

  Approximately 2 years

• Blood Chemistry composite

  Approximately 2 years

• Preoperative sarcopenia using a muscular index

  Approximately 2 years

• Measurement of lymphatic metastasis

  Approximately 2 years

Study Arms (2)

Pancreatic Cancer Patients

ACTIVE COMPARATOR

During the surgical resection for the pancreatic cancer a muscle tissue biopsy sample will be performed.

Procedure: Muscle Tissue Biopsy Sample

Surgical Patients with benign pathology

ACTIVE COMPARATOR

During surgical resection for patients with benign right upper quadrant pathology, a muscle tissue biopsy sample will be performed.

Procedure: Muscle Tissue Biopsy Sample

Interventions

Muscle Tissue Biopsy Sample PROCEDURE

During surgical resection, to enter the abdominal cavity, anterior muscle groups such as the rectus abdominous muscle. This group of muscle is divided. During division, muscle fibers are released from fascial group and discarded off the operative field. This will be the target for specimen collection.

Pancreatic Cancer Patients; Surgical Patients with benign pathology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pancreatic Cancer Patients who are potentially surgically resectable.

You may not qualify if:

• Patients who do not meet the criteria for surgical resection.

Sponsors & Collaborators

• University of Florida: lead
• The V Foundation for Cancer Research: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UF Health

Gainesville, Florida, 32611, United States

Location

Related Publications (2)

• Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.

  PMID: 19342610 BACKGROUND

• Evans WJ, Morley JE, Argiles J, Bales C, Baracos V, Guttridge D, Jatoi A, Kalantar-Zadeh K, Lochs H, Mantovani G, Marks D, Mitch WE, Muscaritoli M, Najand A, Ponikowski P, Rossi Fanelli F, Schambelan M, Schols A, Schuster M, Thomas D, Wolfe R, Anker SD. Cachexia: a new definition. Clin Nutr. 2008 Dec;27(6):793-9. doi: 10.1016/j.clnu.2008.06.013. Epub 2008 Aug 21.

  PMID: 18718696 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Andrew Judge, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: August 4, 2015
• Study Start: March 1, 2016
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

US (1)