Symptoms and General Pathology

All Conditions

Fatigue

Antineoplastic Agents

All Drugs and Chemicals

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Androgens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

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

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

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

Placebo

Rony Dev, DO

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.

Background for Study:

Testosterone is the main sex hormone for males. Cancer, cancer treatments and cancer symptoms can cause its levels in the body to drop below normal. When testosterone is taken as a drug (called "testosterone replacement therapy"), this therapy is designed to return the testosterone levels to normal. This may help to control symptoms of low testosterone levels, which may include fatigue.

In addition to fatigue, low testosterone levels may also cause depression, loss of sexual desire, loss of appetite, and/or physical changes such as effects on strength, stamina (long-lasting strength and energy), energy level, and body composition. In this study, researchers also want to learn how testosterone therapy may affect these other symptoms that may occur. To measure these effects, questionnaires and other tests will be used.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. One group will receive testosterone, and the other group will receive a placebo. A placebo is a substance that looks like the study drug but has no active ingredients. There is an equal chance that you will be assigned to either group.

Neither you, the study doctor, nor the study staff will know whether you are receiving testosterone or placebo until Day 72. However, if needed for your safety, the study doctor and staff will be able to find out which one you are receiving.

You will receive testosterone or placebo by injection into your buttock muscle, about every 15 days until Day 72 (+/- 3 days). This is at baseline (+/- 3 days), Day 15 (+/- 3 days), Day 29 (+/- 3 days), Day 43 (+/- 3 days), and Day 57 (+/- 3 days).

As part of the routine blood tests performed at your study visits, your testosterone levels will be measured. If your testosterone level is too high, your testosterone/placebo dose will be lowered. If your testosterone level is too low, your testosterone/placebo dose will be raised.

Baseline Visit:

On Day 1, you will have a series of tests performed.

Your strength and stamina will be measured by hand-grip strength tests, a Get-Up-and-Go test and a 6-minute walk test.

* For the hand-grip strength tests, you will grip a device with your hand as hard as you can. You will repeat both of these tests 3 times for each hand.
* For the Get-Up-and-Go test, you will be timed to see how long it takes you to get up from sitting in a chair, walk 10 feet, turn around and walk back to the chair, and sit down.
* For the 6-minute walk test, you will be timed while you walk on a 100-foot loop. You will walk 50 feet and then turn and walk back to the beginning. You will do this at a walking speed that feels comfortable and for as many times as you can in 6 minutes.

A muscle on your upper arm will be measured. This will be the arm you do not normally use for writing.

You will be weighed on a scale that measures your body composition. Body composition includes measurements of your body fat, "lean" (non-fat) body weight, and how much water is in your body.

Blood (about 1-2 tablespoons) will be drawn for research on inflammation, other proteins and hormones. These tests are designed to help researchers learn if testosterone affects inflammation and/or fatigue, and if increased levels of certain hormones may help increase muscle and appetite.

You will be given a device called an Actiwatch, which is worn like a wristwatch. It will measure your physical activity. The research staff will show you how to use it. You should wear it through Day 29 of the study. You will return it at your Day 15 and Day 29 study visit.

Other Study Visits:

On Days 15, 29, 43, 57 and 72 (all +/- 3 days), the following tests and procedures will be performed:

* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will complete questionnaires.
* Your strength and stamina, arm muscle, and body composition will be measured.
* A medical history and physical exam will be performed on Day 29 (+/-3 days) and Day 72 (+/3 days)

If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive mental health screening.

Length of Study:

You may remain on study until Day 72. You will be taken off study early if intolerable side effects occur, the cancer gets worse, or the fatigue gets worse.

Optional Open-Label Testosterone Dosing:

At your Day 72 visit, you will find out if you were receiving testosterone or placebo. Those participants who were receiving testosterone will be given the option to keep receiving testosterone (off-study). Those participants who were receiving the placebo will also be given the option to receive testosterone (off-study). This is called "Open-Label Testosterone Dosing."

If you choose to receive testosterone off-study after Day 72, you will receive testosterone by injection into your buttock muscle.

This is an investigational study. Testosterone replacement therapy is commercially available and FDA approved for use in men with HIV, for treating low testosterone levels and fatigue. (HIV is a virus that affects the immune system.) At this time, it is investigational to use testosterone replacement therapy to treat low testosterone levels and fatigue in patients with cancer.

Up to 126 patients will take part in this multicenter study. Up to 80 patients will be enrolled at M. D. Anderson Cancer Center.

Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

A Preliminary Trial of Testosterone Replacement for Fatigue in Male Hypogonadic Patients With Advanced Cancer.

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.

The ESAS assessed 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0-10 (0 = no symptom, 10 = worst possible severity). Depression was assessed using the 14-item HADS questionnaire. Each item on the questionnaire was scored from 0-3. Total Scores for the HADS Questionnaire range from 0 to 42 with higher scores denoting feeling of depression.

M.D. Anderson Cancer Center

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

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.

Rony Dev, DO / Assistant Professor

FACIT-F Total Score (29 days-baseline)

FACIT-F Fatigue Subscale (29 days-baseline)

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

Anxiety, ESAS

Depression, HADS

Well being, ESAS

Sleep, ESAS

Appetite, ESAS

Dyspnea, ESAS

Drowsiness, ESAS

Nausea, ESAS

Fatigue, ESAS

Pain, ESAS

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

Overall Study

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Testosterone 200 mg administered parenterally by intramuscular (IM) injection every 2 weeks

Initial dose of Testosterone 200 mg IM administered followed by 200 mg - 400 mg every 2 weeks.

Paul Mathew, MD

Primary Objective:

1. To assess the prostate-specific antigen (PSA)-response (50% decline) to Testosterone Replacement Therapy (TRT) in men with "intermediate and good-risk" Castration-Resistant Prostate Cancer (CRPC).

Secondary Objectives:

1. To assess the objective response and time-to-progression with TRT in CRPC.
2. To assess serial changes in quality of life with TRT in these CRPC subsets.
3. Translational: To study kinetics of circulating tumor cells with TRT and molecular correlates of response to TRT in CRPC.

Generally, castration therapy has been used indefinitely for prostate cancer patients because some tumors seem to grow faster with testosterone present. Researchers want to study the effect of testosterone only in patients whose tumors have had a maximum response to castration therapy. Researchers want to find out if these patients' disease may be better controlled with testosterone replacement therapy.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded and there will be a review of all medicines you may be currently taking. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will have blood drawn (about 4 teaspoons) and urine collected for routine tests. You will have a chest x-ray, an electrocardiogram (ECG--a test to measure the electrical activity of the heart), a bone scan, and a computed tomography (CT) scan of your abdomen and pelvis. If the study doctor thinks it is necessary, you may have an assessment of your mental status. For this assessment, you will be asked questions about your attention span, memory, and mood disturbances. It will take about 25 minutes to complete.

If you are found to be eligible to take part in this study, you will begin receiving testosterone enanthate replacement therapy every 2 weeks by an injection into a muscle.

Every 2 weeks, you will go to the clinic for your testosterone injection, and blood (about 2 teaspoons) will be drawn to check the testosterone level in your blood. This will help the study doctor learn what dose you will receive for the next 2 weeks. After your Week 8 visit, blood (about 2 teaspoons) will be drawn to check the testosterone level in your blood every 4 weeks for the rest of your time on this study.

At the Week 8 and 24 visits, you will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may be experiencing. Your disease status will be evaluated to learn its response to treatment. Blood (about 4 teaspoons) will be drawn for routine tests, and you will have repeat imaging scans (like the ones you had at your screening visit) to evaluate your disease. If the study doctor thinks that your mental status should be assessed again, you will have another assessment (at or around Week 24) like the one completed during your screening visit.

You may remain on this study indefinitely unless your disease gets worse or you experience any intolerable side effects.

If your participation ends on this study for any of the above reasons, you will have an end-of-study visit. During this visit, you will have blood drawn (about 4 teaspoons) for routine testing. You will be asked about any side effects you may be experiencing, and your disease response to treatment will be evaluated.

This is an investigational study. Testosterone enanthate is commercially available. Testosterone replacement therapy is not FDA approved for this disease, and in some cases, has been disallowed for use in prostate cancer. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Testosterone in Castration-Resistant Prostate Cancer

Testosterone Replacement Therapy in Castration-Resistant Prostate Cancer

Rate is the number of participants with PSA-response defined as PSA \> or equal to 50%-decline in PSA from baseline value sustained for at least 4 weeks with be no evidence of progressive disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients	NCT00965341	Advanced Cancer	Testosterone Placebo	18 Years -	M.D. Anderson Cancer Center
Testosterone in Castration-Resistant Prostate Cancer	NCT00577980	Prostate Cancer	Testosterone	-	M.D. Anderson Cancer Center
Testosterone in Castration-Resistant Prostate Cancer	NCT00577980	Prostate Cancer	Testosterone	-	M.D. Anderson Cancer Center
Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients	NCT00965341	Advanced Cancer	Testosterone Placebo	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for testosterone replacement therapy