Changes in Muscle Tissue in Patients With Pancreatic Cancer

NCT00369460 | Completed DMC

• 2 other identifiers: CASE8205P30CA043703
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (5)

• 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.

• Correlation of changes in FFM with survival at 6 months

  at 6 months

• 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.

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

  at 6 months

• 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.

Interventions

physiologic testing OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Joanna M. Brell, MD

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: January 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)