Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

NCT00965341 | Completed Phase 3 Results DMC

• 1 other identifier: 2008-0262
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Cancer; Fatigue; Testosterone Replacement Therapy; Depo-Testosterone; Testosterone cypionate; Testosterone enanthate; Hypogonadic; Functional Assessment of Cancer Therapy-Fatigue subscale; FACIT-F

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)

  The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement.

  Day 29 (+/- 3 days)

Secondary Outcomes (1)

• The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).

  Day 29 (+/- 3 days)

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.

Drug: Testosterone

Placebo

PLACEBO COMPARATOR

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

Interventions

Testosterone DRUG

Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.

Also known as: Androderm, AndroGel, Delatestryl, Depo-Testosterone, Testosterone enanthate, Testosterone cypionate

Testosterone

Placebo DRUG

Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of \< 70 ng/dL.
• 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).
• 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.
• Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment.
• 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.
• Eastern Cooperative Oncology Group (ECOG) PS \</= 3 and participants must be able to stand up with or without assistance and to ambulate.
• 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.

You may not qualify if:

• Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study
• Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) \>19.
• Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin.
• A history of untreated obstructive sleep apnea.
• Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.
• 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.
• Patients exhibiting clinically diagnosed severe dehydration are ineligible.
• Patients with a history of uncontrolled arrhythmia.
• Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA)
• 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%.
• Uncontrolled thyroid disease
• 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)
• Patients on warfarin, cyclosporine, dong quai, eucalyptus, dicumarol, germander, Jin bu huan, kava, pennyroyal, chaparral, comfrey, phenprocoumon are ineligible for this study.
• 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.
• Patients who have a known sensitivity to sesame seed products.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

The DeBakey VA Medical Center/Baylor College of Medicine

Houston, Texas, 77030, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Neoplasms; Fatigue

Interventions

Testosterone; testosterone enanthate; testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

The study has several limitations; the follow-up visits at two weekly intervals were burdensome for many patients. Others did not want to enroll in a placebo-controlled trial, and many patients regarded the intramuscular injections as too painful.

Results Point of Contact

• Title: Rony Dev, DO / Assistant Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

HMoreno@mdanderson.org

713-745-4192

Study Officials

• Rony Dev, DO

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 25, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 13, 2016
• Results First Posted: September 13, 2016

Record last verified: 2016-07

Locations

US (2)