Clinical trial NCT00369460: Changes in Muscle Tissue in Patients With Pancreatic Cancer
Official title: Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-08-29
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief 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.

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 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

Primary outcomes:
measure: Fat-free mass (FFM)
timeFrame: 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.
measure: Correlation of changes in FFM with survival at 6 months
timeFrame: at 6 months
measure: Incidence of lymphocytopenia
timeFrame: 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.
measure: Correlation of pretreatment total lymphocyte count, treatment response, and survival at 6 months
timeFrame: at 6 months
measure: Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count
timeFrame: At start of cancer treatment and re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Joanna M. Brell, MD
role: PRINCIPAL_INVESTIGATOR
References: