Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00965341
First received: August 21, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

The goal of this clinical research study is to learn if and how testosterone replacement therapy may affect fatigue in males with advanced cancer and low testosterone levels.


Condition Intervention Phase
Advanced Cancer
Drug: Testosterone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Preliminary Trial of Testosterone Replacement for Fatigue in Male Hypogonadic Patients With Advanced Cancer.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days) [ Time Frame: Baseline to Day 29 (+/- 3 days) ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testosterone
Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
Drug: Testosterone
Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
Other Names:
  • Androderm
  • AndroGel
  • Delatestryl
  • Depo-Testosterone
  • Testosterone enanthate
  • Testosterone cypionate
Placebo Comparator: Placebo
Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
Drug: Placebo
Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of < 70 ng/dL.
  2. Male patients who have fatigue present every day for the last two weeks and have an Edmonton Symptom Assessment System (ESAS) fatigue score during the last 24 hours of >/= to 4 on a 0 to 10 scale (in which 0 = no fatigue and 10 = worst possible fatigue).
  3. Male patients who are willing to receive intramuscular injections every 2 weeks and are 18 years of age or older are eligible for this study.
  4. Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment.
  5. Prostatic Specific Antigen (PSA) level must be lower than 4.0 ng/mL to be eligible for this study and Digital Rectal Exam (DRE) must be normal.
  6. ECOG PS </= 3 and participants must be able to stand up with or without assistance and to ambulate.
  7. Hemoglobin (Hgb) >/= 9 g/dL. If the patient has not had blood drawn for a hemoglobin level in the past 28 days, one will be done to determine eligibility. Patients with a hemoglobin < 9 g/dL will be referred for treatment of their anemia.

Exclusion Criteria:

  1. Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study
  2. Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >19.
  3. Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin.
  4. A history of untreated obstructive sleep apnea.
  5. Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe COPD requiring home oxygen.
  6. Patients who have evidence of pre-existing hypopituitarism/hypogonadism including status post bilateral orchiectomy, for which replacement therapy is mandated, are ineligible for this study.
  7. Patients exhibiting clinically diagnosed severe dehydration are ineligible.
  8. Patients with a history of uncontrolled arrhythmia.
  9. Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA)
  10. Diabetics with a history of frequent episodes of hypoglycemia or uncontrolled diabetes mellitus (DM) defined as a fasting glucose over 200 mg/dL or HbA1c above 8%.
  11. Uncontrolled thyroid disease
  12. Hypercalcemia (corrected calcium > 10.5 g/dL); estimated glomerular filtration rate < 60 mg/min using the Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR); ALT > 3x the upper limit of normal (UNL)
  13. Patients on warfarin, cyclosporine, dong quai, eucalyptus, dicumarol, germander, Jin bu huan, kava, pennyroyal, chaparral, comfrey, phenprocoumon are ineligible for this study.
  14. Unstable symptoms could contribute to fatigue such as severe pain (score> 6 on ESAS) or severe depression (defined as a score of 15 or greater on the Depression Subscale of the Hospital Anxiety Depression Scale [HADS]). These symptoms should be resolved or stable for >/= 2 weeks at baseline for inclusion into study.
  15. Patients with hematocrit (Hct) > upper normal limits (UNL) will be excluded due to possible polycythemia. If the patient has not had blood drawn for a hematocrit level in the past 28 days, one will be performed at baseline to determine eligibility.
  16. Patients who have a known sensitivity to sesame seed products.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965341

Locations
United States, Texas
The DeBakey VA Medical Center/Baylor College of Medicine
Houston, Texas, United States, 77030
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Rony Dev, DO UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00965341     History of Changes
Other Study ID Numbers: 2008-0262
Study First Received: August 21, 2009
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Fatigue
Testosterone Replacement Therapy
Depo-Testosterone
Testosterone cypionate
Testosterone enanthate
Hypogonadic
Functional Assessment of Cancer Therapy-Fatigue subscale
FACIT-F

Additional relevant MeSH terms:
Fatigue
Neoplasms
Signs and Symptoms
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014