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

NCT00529230 | Terminated

• 1 other identifier: ID01-451
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer; Hypogonadism; Pain

Keywords

Advanced Cancer; Chronic Opioid Therapy; Secondary Hypogonadism; Cancer-Related Pain Syndromes; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes

  3 Years

Study Arms (1)

Chronic opioid therapy + Gonadal function

Males on chronic opioid therapy for cancer-related pain syndromes

Behavioral: Questionnaire; Other: Blood draws to assess gonadal function

Interventions

Questionnaire BEHAVIORAL

A set of questionnaires regarding sexual function, physical and psychological symptoms.

Chronic opioid therapy + Gonadal function

Blood draws to assess gonadal function OTHER

Testosterone, FSH, and LH levels at study onset.

Chronic opioid therapy + Gonadal function

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males on chronic opioid therapy for cancer-related pain syndromes.

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draws to assess gonadal function.

MeSH Terms

Conditions

Hypogonadism; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Arun Rajagopal, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 14, 2007
• Study Start: December 11, 2001
• Primary Completion: February 19, 2004
• Study Completion: February 19, 2004
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

US (1)