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

Phase 3
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

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

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

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

- 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

Other Study Visits:

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

- 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.

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

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 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

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days)

Outcome Time Frame:

Baseline to Day 29 (+/- 3 days)

Safety Issue:


Principal Investigator

Rony Dev, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

September 2012

Related Keywords:

  • Advanced Cancer
  • Cancer
  • Fatigue
  • Testosterone Replacement Therapy
  • Depo-Testosterone
  • Testosterone cypionate
  • Testosterone enanthate
  • Hypogonadic
  • Functional Assessment of Cancer Therapy-Fatigue subscale
  • Fatigue
  • Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030
The DeBakey VA Medical Center/Baylor College of Medicine Houston, Texas  77030