Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes

Stopped early

Conditions studied: Advanced Cancer, Hypogonadism, Pain

In brief

Primary Objective: 1\. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes. Secondary Objective: 1\. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.

Key facts

Study ID

NCT00529230

Run by

M.D. Anderson Cancer Center

People needed

46

Starts

2001-12-11

Expected to finish

2004-02-19

Last updated by the study team

2018-10-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Chronic pain greater than one year.
• Male.
• Cancer status must be stable or in remission. For this study, "stable disease" is defined as identifiable disease at local or metastatic sites that has shown no progression over the previous 3 months and there has been no cancer treatment for ³ 3 months.
• Patients must be on chronic opioid therapy on a continuous basis in the preceding twelve months with a Morphine Equivalent Daily Dose (MEDD) ³ 200.
• Age >/= 18. The questionnaires used in this study have been validated only in the adult population. In addition, some of the questionnaires contain questions of a sensitive nature and are not appropriate in the pediatric population.
• Patients must be able to understand and sign the consent form.

You may not qualify if…

• Patient who refuses to participate in the study or determined incapable of completing the research.
• Patients with pre-existing hypopituitarism. Causes include certain tumors (pituitary adenomas, hypothalamic tumors), inflammatory diseases (granulomatous diseases), vascular diseases (postpartum necrosis, carotid aneurysm), traumatic/destructive events (prior surgery, trauma, or radiation), developmental anomalies, infiltration.
• Patients who tare taking any drugs that may affect the hypothalamic-pituitary-gonadal axis.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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