Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

2014-07-24 14:11:45 | BioPortfolio


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.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

- Your complete medical history will be recorded.

- A physical exam will be performed.

- The size and health of your prostate gland will be checked using a digital rectal exam. For this exam, your prostate will be felt by the doctor through your rectum. This exam is for routine care.

- You will be asked about all medications you are taking.

- You will complete 6 questionnaires. In total, this will take about 45 minutes. The questionnaires ask about any symptoms and side effects you may be having.

- Blood (about 1 tablespoon) will be drawn for routine tests.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

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.

Other Instructions:

While you are on study, you should contact the study staff before you start any new drugs (such as prescription drugs or over-the-counter drugs).

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Advanced Cancer


Testosterone, Placebo


UT MD Anderson Cancer Center
United States




M.D. Anderson Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T14:11:45-0400

Clinical Trials [3523 Associated Clinical Trials listed on BioPortfolio]

Study to Determine the Prevalence of Osteoporosis in Patients With Advanced Prostate Cancer Treated With Hormonal Manipulation

Osteoporosis, or thinning of the bones is a common disorder which can cause significant morbidity in terms of pain and fracture. One of the causes of osteoporosis is a low or absent testos...

The Effect of Testosterone on Mood and Quality of Life

We hypothesize that testosterone replacement will improve mood and quality of life in older men with low testosterone and mild depression. Study subjects will receive either testosterone g...

EndogenousTestosterone Response to a Testosterone Boosting Supplement

The purpose of this study is to determine whether a proprietary 'testosterone-boosting' supplement, when used as recommended by the manufacturer, results in an increase in testosterone lev...

The Testosterone Trial

The Testosterone Trials are a multi-center set of trials involving 12 clinical sites geographically distributed across the United States. The primary specific aims are to test the hypothe...

Testosterone Replacement in Men With Diabetes and Obesity

The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy....

PubMed Articles [17300 Associated PubMed Articles listed on BioPortfolio]

The Role of Testosterone Therapy in the Setting of Prostate Cancer.

The role of testosterone in the development of prostate cancer and the safety of testosterone therapy (TTh) after prostate cancer treatment, or in the setting of active surveillance, remains controver...

Testosterone treatment and the risk of aggressive prostate cancer in men with low testosterone levels.

Testosterone treatment of men with low testosterone is common and, although relatively short-term, has raised concern regarding an increased risk of prostate cancer (CaP). We investigated the associat...

Low Free Testosterone and Prostate Cancer Risk: A Collaborative Analysis of 20 Prospective Studies.

Experimental and clinical evidence implicates testosterone in the aetiology of prostate cancer. Variation across the normal range of circulating free testosterone concentrations may not lead to change...

Measuring testosterone and testosterone replacement therapy in men receiving androgen deprivation therapy for prostate cancer: A survey of UK uro-oncologists' opinions and practice.

To explore the practice and attitudes of uro-oncologists in the UK regarding monitoring testosterone levels and the use of testosterone replacement therapy (TRT) in their prostate cancer patients trea...

Testosterone therapy for high-risk prostate cancer survivors: a systematic review and meta-analysis.

A systematic review and meta-analysis was performed to determine the relationship between testosterone therapy and risk of recurrence in testosterone-deficient survivors of curatively treated high-ris...

Medical and Biotech [MESH] Definitions

Steroidal compounds related to TESTOSTERONE, the major mammalian male sex hormone. Testosterone congeners include important testosterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with androgenic activities.

A potent androgenic metabolite of TESTOSTERONE. Dihydrotestosterone (DHT) is generated by a 5-alpha reduction of testosterone. Unlike testosterone, DHT cannot be aromatized to ESTRADIOL therefore DHT is considered a pure androgenic steroid.

A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.

An antineoplastic agent that is a derivative of progesterone and used to treat advanced breast cancer.

Tumors or cancer of the PROSTATE which can grow in the presence of low or residual amount of androgen hormones such as TESTOSTERONE.

More From BioPortfolio on "Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients"

Quick Search


Relevant Topics

Diabetes Diabetes Endocrine Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several groups of h...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Searches Linking to this Trial