Prevalence of Hypogonadism in Male Cancer Patients | NCT00472940

Studies
Prevalence of Hypogonadism in Male Cancer Patients

NCT00472940

Sponsor

Baylor College of Medicine

Status

Completed

Last Update Posted

Nov 27, 2020Actual

Enrollment

135Actual

Phase

Not provided

Conditions

Cancer
Hypogonadism

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Sep 2, 2020Actual

Completion Date

Sep 2, 2020Actual

First Submitted Date

May 11, 2007

First Submission Date that Met QC Criteria

May 11, 2007

First Posted Date

May 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2020

Last Update Posted Date

Nov 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marco Marcelli, Professor, Medicine-Endocrinology, Baylor College of MedicinePrincipal Investigator

Lead Sponsor

Baylor College of MedicineOTHER

Collaborators

Name	Class
Michael E. DeBakey VA Medical Center	FED
Solvay Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cancer and its complications are common problems. In most cases, this condition has a profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased sexual drive, depression and poor appetite are commonly seen in these patients. However, these symptoms also are seen in men with other conditions including those with low testosterone levels.

The objective of this study is to determine the number of male patients with cancer that have low testosterone levels and to establish the relationship between testosterone levels and the symptoms that these patients experience.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

135Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male subjects ≥ 18 years of age with histological diagnosis of cancer for cancer group.
Provide written informed consent prior to screening.
Histological diagnosis of cancer other than non-melanoma skin cancer for the two cancer groups.

Exclusion Criteria:

Concomitant use of GH, Megestrol, Marinol, or any other anabolic agent, appetite stimulant (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feedings, or parenteral nutrition during the 3 months prior to entering the study.
Participation in a clinical trial with investigational agents within 1 month of enrollment.
Prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male subjects with cancer and non-cancer controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose M Garcia, MD	Baylor College of Medicine, Michael E. DeBakey VAMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michael E. DeBakey Veterans Affairs Medical Center		Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16688773	Background	Garcia JM, Li H, Mann D, Epner D, Hayes TG, Marcelli M, Cunningham GR. Hypogonadism in male patients with cancer. Cancer. 2006 Jun 15;106(12):2583-91. doi: 10.1002/cncr.21889.
22419719	Derived	Burney BO, Hayes TG, Smiechowska J, Cardwell G, Papusha V, Bhargava P, Konda B, Auchus RJ, Garcia JM. Low testosterone levels and increased inflammatory markers in patients with cancer and relationship with cachexia. J Clin Endocrinol Metab. 2012 May;97(5):E700-9. doi: 10.1210/jc.2011-2387. Epub 2012 Mar 14.

ID	Term
D009369	Neoplasms
D007006	Hypogonadism
D002100	Cachexia

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases
D015431	Weight Loss
D001836	Body Weight Changes