Changes in Muscle Tissue in Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00369460
First received: August 24, 2006
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

RATIONALE: Measuring changes in muscle tissue in patients with cancer may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.

PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer.


Condition Intervention
Pancreatic Cancer
Other: physiologic testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Fat-free mass (FFM) [ Time Frame: Patients will have body mass index measured before start of cancer treatment of the patient's choosing. Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. ] [ Designated as safety issue: No ]
  • Correlation of changes in FFM with survival at 6 months [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Incidence of lymphocytopenia [ Time Frame: Total lymphocyte count measured before start of cancer treatment and at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. ] [ Designated as safety issue: No ]
  • Correlation of pretreatment total lymphocyte count, treatment response, and survival at 6 months [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count [ Time Frame: At start of cancer treatment and re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: physiologic testing
    Weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing. Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
Detailed Description:

OBJECTIVES:

  • Demonstrate a decrease/increase of fat-free mass (FFM) by 10% from baseline, based on tumor progression/regression, within each patient with inoperable locally advanced or metastatic pancreatic carcinoma.
  • Determine the correlation between changes in FFM and 6-month survival.
  • Confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
  • Demonstrate an interaction between pretreatment total lymphocyte count, treatment response, and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
  • Collect adjuvant information, such as weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count, in these patients.

OUTLINE: This is a pilot study.

Patients will have weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing.

Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.

PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

DISEASE CHARACTERISTICS:

  • Biopsy-proven inoperable locally advanced or metastatic pancreatic adenocarcinoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Must be able to stand unassisted on a scale
  • Must not have pacemaker or implanted defibrillator

PRIOR CONCURRENT THERAPY:

  • Prior chemotherapy or radiotherapy allowed
  • No concurrent use of any of the following:

    • Corticosteroids

      • Steroids as anti-emetics associated with chemotherapy allowed
    • Anabolic steroids
    • Thalidomide
    • Megesterol
    • Eicosapentaenoic acid (EPA)

      • Nutritional supplements without EPA allowed
    • Juven
  • Concurrent enrollment in other clinical trials allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369460

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Joanna M. Brell, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Joanna Brell, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00369460     History of Changes
Other Study ID Numbers: CASE8205, P30CA043703, CASE8205
Study First Received: August 24, 2006
Last Updated: June 9, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
recurrent pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014