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CompletedNCT00369460Updated Oct 12, 2015

Changes in Muscle Tissue in Patients With Pancreatic Cancer

An observational study in Pancreatic Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Case Comprehensive Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 9 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Primary care clinic

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9 participants (actual)

Interventions

  • Otherphysiologic 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.

06

What researchers measure

Primary outcomes

  1. 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.

  2. Correlation of changes in FFM with survival at 6 months

    Time frame: at 6 months

  3. 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.

  4. Correlation of pretreatment total lymphocyte count, treatment response, and survival at 6 months

    Time frame: at 6 months

  5. 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.

07

Study locations

1 site
  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
    Cleveland, Ohio 44106-5065, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00369460
Lead sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 29, 2006
Start date
Jan 2006
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Oct 12, 2015

Study contacts

Joanna M. Brell, MD
principal investigator · Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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