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TerminatedNCT00529230Updated Oct 25, 2018

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

An observational study in Advanced Cancer, Hypogonadism and Pain, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by M.D. Anderson Cancer Center · Observational

Why this study was terminated
Low accrual rate.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
46
Ages
18 Years and older
Sex
Male
01

Study 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.
Read the 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.

02

Conditions studied

  • Advanced Cancer
  • Hypogonadism
  • Pain

Keywords

  • Advanced Cancer
  • Chronic Opioid Therapy
  • Secondary Hypogonadism
  • Cancer-Related Pain Syndromes
  • Questionnaire
03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 46 is below the median of 96 across 66 observational studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
46 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • BehavioralQuestionnaire

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

  • OtherBlood draws to assess gonadal function

    Testosterone, FSH, and LH levels at study onset.

06

What researchers measure

Primary outcomes

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

    Time frame: 3 Years

07

Study locations

1 site
  • U.T.M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00529230
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Sep 14, 2007
Start date
Dec 11, 2001
Primary completion
Feb 19, 2004
Completion
Feb 19, 2004
Last update
Oct 25, 2018

Study contacts

Arun Rajagopal, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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