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Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2009
First Received: August 21, 2009   Last Updated: September 28, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00965341
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Efficacy Study
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 ]

Estimated Enrollment: 126
Study Start Date: September 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Testosterone: Active Comparator Drug: Testosterone
Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
Placebo: Placebo Comparator 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 3 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) >/=10 g/dL . If the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine eligibility. Patients with a hemoglobin < 10 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); creatinine clearance < 60 mg/min; 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 two weeks, one will be performed at baseline to determine eligibility.
  16. Patients who have a known sensitivity to sesame seed products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965341

Contacts
Contact: Egidio Del Fabbro, MD 713-792-3967

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Egidio Del Fabbro, MD            
The DeBakey VA Medical Center/Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Egidio Del Fabbro, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Egidio Del Fabbro, MD / Assistant Professor )
Study ID Numbers: 2008-0262
Study First Received: August 21, 2009
Last Updated: September 28, 2009
ClinicalTrials.gov Identifier: NCT00965341     History of Changes
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Signs and Symptoms
Anabolic Agents
Neoplasms
Testosterone
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on February 08, 2010