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

This study has been terminated.
(Low accrual rate.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00529230
First Posted: September 14, 2007
Last Update Posted: August 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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.


Condition Intervention
Advanced Cancer Hypogonadism Pain Behavioral: Questionnaire Other: Blood draws to assess gonadal function

Study Type: Observational
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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes [ Time Frame: 3 Years ]

Biospecimen Retention:   Samples Without DNA
Blood draws to assess gonadal function.

Enrollment: 46
Study Start Date: December 2001
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic opioid therapy + Gonadal function
Males on chronic opioid therapy for cancer-related pain syndromes
Behavioral: Questionnaire
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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males on chronic opioid therapy for cancer-related pain syndromes.
Criteria

Inclusion Criteria:

  1. Chronic pain greater than one year.
  2. Male.
  3. 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.
  4. 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.
  5. 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.
  6. Patients must be able to understand and sign the consent form.

Exclusion Criteria:

  1. Patient who refuses to participate in the study or determined incapable of completing the research.
  2. 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.
  3. Patients who tare taking any drugs that may affect the hypothalamic-pituitary-gonadal axis.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00529230


Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Arun Rajagopal, MD M.D. Anderson Cancer Center
  More Information

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00529230     History of Changes
Other Study ID Numbers: ID01-451
First Submitted: September 13, 2007
First Posted: September 14, 2007
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Chronic Opioid Therapy
Secondary Hypogonadism
Cancer-Related Pain Syndromes
Questionnaire

Additional relevant MeSH terms:
Hypogonadism
Cancer Pain
Gonadal Disorders
Endocrine System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents