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

October 24, 2018 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Arun Rajagopal, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2001

Primary Completion (Actual)

February 19, 2004

Study Completion (Actual)

February 19, 2004

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID01-451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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