Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00499798|
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : May 30, 2017
RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors may help doctors learn about the long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.
|Condition or disease|
|Brain and Central Nervous System Tumors Chemotherapeutic Agent Toxicity Infertility|
- Assess if temozolomide induces any changes in standard semen or sperm analysis parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology) in patients with newly diagnosed, recurrent, or progressive primary malignant brain tumors.
OUTLINE: This is a pilot study.
During treatment with temozolomide, patients undergo semen or sperm sample collection at baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology.
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Temozolomide Induced Changes in Semen/Sperm Analysis in Men With Newly Diagnosed, Progressive or Recurrent Primary Malignant Brain Tumors|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||September 2014|
|patients on temozolimide for brain cancer|
- assess any changes in standard semen/sperm analysis parameters [ Time Frame: 6 months ]assess if Temozolomide induces any changes in standard semen/sperm analysis parameters (volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499798
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Glenn J. Lesser, MD||Wake Forest University Health Sciences|
|Principal Investigator:||Robert T. Blackwood, PA-S||Wake Forest University Health Sciences|