Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes
1. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes.
1. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.
Other: Blood draws to assess gonadal function
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes|
- Prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood draws to assess gonadal function.
|Study Start Date:||December 2001|
|Study Completion Date:||December 2004|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Chronic opioid therapy + Gonadal function
Males on chronic opioid therapy for cancer-related pain syndromes
A set of questionnaires regarding sexual function, physical and psychological symptoms.Other: Blood draws to assess gonadal function
Testosterone, FSH, and LH levels at study onset.
Studies have shown that non-cancer patients taking opioid pain medication for a long period of time can have decreased libido and decreased sexual function.
Individuals may be asked to take part in this study even if they have not taken opioid pain medications in the last twelve months. These individuals would also be enrolled to learn if long-term treatment of cancer-related pain with opioid medications results in decreased sex hormones, decreased sex drive, and increased fatigue or depression.
Participants in this study will be asked to complete a set of questions about their sexual functions, physical symptoms, and psychological symptoms such as fatigue and depression. It will take about 25 minutes to complete the questionnaires.
Participants will have blood drawn (about 2 teaspoons of blood) to test their sex hormone level. Participants who are identified as having low sex hormone level (hypogonadism) will be referred to an endocrinologist for standard hormone replacement therapy.
This is a one-time evaluation, no follow-up visit or questionnaires are required.
This is an investigational study. A total of 108 individuals will take part in this study. All will be enrolled at UTMDACC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529230
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Arun Rajagopal, MD||M.D. Anderson Cancer Center|