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Completed

NCT Number: NCT00369460

Changes in Muscle Tissue in Patients With Pancreatic Cancer

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2006
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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