Changes in Muscle Tissue in Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Pilot Study of Changes in Fat-Free Mass in Pancreatic Carcinoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369460
• Other study ID #: CASE8205
• Secondary ID: P30CA043703CASE8
• Status: Completed
• Phase: N/A
• First received: August 24, 2006
• Last updated: October 8, 2015
• Start date: January 2006
• Est. completion date: July 2009

Study information

• Verified date: October 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat-free mass (FFM)		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.	No
Primary	Correlation of changes in FFM with survival at 6 months		at 6 months	No
Primary	Incidence of lymphocytopenia		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.	No
Primary	Correlation of pretreatment total lymphocyte count, treatment response, and survival at 6 months		at 6 months	No
Primary	Collection of information on weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count		At start of cancer treatment and re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.	No