Brain and Central Nervous System TumorsNCT00631137
Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma
A study testing testosterone gel applied to skin and whey powder protein in people with Brain and Central Nervous System Tumors and Musculoskeletal Complications, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Brain and Central Nervous System Tumors, Musculoskeletal Complications
- What is being tested?
- testosterone gel applied to skin and whey powder protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Newly diagnosed high-grade glioma, including the following subtypes:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Requires dexamethasone at a dose of > 4 mg/day to control symptoms of tumor-related edema at time of study enrollment AND has been on a stable dose of steroids for ≥ 5 days prior to study enrollment
- Completed ≥ 80% of prescribed radiotherapy
- Hypogonadal, defined as serum testosterone level < 350 ng/dL
- No history of prostate or breast cancer
- No benign prostatic hypertrophy requiring therapy OR AUA score of ≥ 8
- PSA ≤ 4 ng/mL
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Able to keep daily records or has a care provider that agrees to keep daily records of drug administration
- No clinical history of congestive heart failure requiring therapy
- No psychotic disorder requiring active treatment
- No structured exercise program involving exercise for > 3 hours/week
- No polycythemia (i.e., hematocrit > 52%)
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior androgen therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.
PURPOSE: This randomized clinical trial is studying how well testosterone gel works in preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.
Read the detailed description
OBJECTIVES:
Primary
- To determine if daily administration of testosterone gel can prevent the development or reduce the severity of muscle weakness in men receiving glucocorticoids for newly diagnosed high-grade glioma.
Secondary
- To compare the difference in percent change from baseline timed functional tests (TFT) between patients who are treated with testosterone gel and those who are not.
- To compare the difference in percent change from baseline activities of daily living as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) between patients who are treated with testosterone gel and those who are not.
- To compare the difference in percent change from baseline leg muscle mass as assessed by CT scan imaging between patients who are treated with testosterone gel and those who are not.
- To estimate the side effects of testosterone gel in these patients.
OUTLINE: Patients are stratified according to daily glucocorticoid dose (< 16 mg/day vs ≥ 16 mg/day), Karnofsky performance status (≤ 80% vs > 80%), and age (≤ 50 years of age vs > 50 years of age). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients receive oral whey protein powder once daily for 7 months.
- Arm II (treatment): Patients apply topical testosterone gel to the shoulder, upper chest, or forearm once daily for 7 months.
Patients undergo strength testing and functional testing (TFT) and complete an activities of daily living questionnaire at baseline and at 1, 3, 5, and 7 months. Patients also undergo CT scan of the leg and laboratory testing at baseline and at 3 and 7 months. Testosterone levels are obtained at baseline and at 1, 3, and 7 months.
Patients complete a daily log of their glucocorticoid dose and to affirm compliance with therapy. Major clinical events related to underlying tumor (i.e., surgery, radiotherapy, initiating chemotherapy, concurrent antiepileptic therapy, deep vein thrombosis, pulmonary embolism, transfusions, seizures, pneumonia, and other forms of infection) are also recorded.
- Being tested
- testosterone gel applied to skin, whey powder protein
- Keywords
- musculoskeletal complications, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone gel applied to skinDrug
Application of testosterone gel
whey powder proteinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control Group | Placebo comparator | whey protein powder Receives: Dietary Supplement: whey powder protein |
| ARM 2 : Treatment Group | Active comparator | Testosterone Gel (10g pouch/day) applied to skin Receives: Drug: testosterone gel applied to skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months
Measured: baseline and at 1, 3, 5, and 7 months
Secondary outcomes (6)
Muscle Strength Testing in Other Proximal Muscles (i.e., Knee Extensors, Knee Flexors, Arm Abductors, Elbow Extensors and Flexors, and Neck Flexors) as Assessed by Dynamometry at Baseline and at 1, 3, 5, and 7 Months
Measured: baseline and at 1, 3, 5, and 7 months
Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months
Measured: baseline and at 1, 3, 5, and 7 months
Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months
Measured: baseline and at 3 and 7 months
Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months
Measured: baseline and at 1, 3, 5, and 7 months
Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities
Measured: while receiving treatment
Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months
Measured: baseline and at 1, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Study terminated due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jaishri O. Blakeley, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631137
- Sponsor's protocol ID
- J0634
- Other IDs
- P30CA006973, JHOC-J0634, NA_00003125, CDR0000584274
- Status last verified
- Aug 2018
- First submitted
- 6 Mar 2008
- Last updated
- 27 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
- ClinicalTrials.gov ID
- NCT00631137
- Acronym / sponsor ID
- J0634
- Keywords
- musculoskeletal complications, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Posted 27 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.
PURPOSE: This randomized clinical trial is studying how well testosterone gel works in preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.
Detailed description
OBJECTIVES:
Primary
- To determine if daily administration of testosterone gel can prevent the development or reduce the severity of muscle weakness in men receiving glucocorticoids for newly diagnosed high-grade glioma.
Secondary
- To compare the difference in percent change from baseline timed functional tests (TFT) between patients who are treated with testosterone gel and those who are not.
- To compare the difference in percent change from baseline activities of daily living as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) between patients who are treated with testosterone gel and those who are not.
- To compare the difference in percent change from baseline leg muscle mass as assessed by CT scan imaging between patients who are treated with testosterone gel and those who are not.
- To estimate the side effects of testosterone gel in these patients.
OUTLINE: Patients are stratified according to daily glucocorticoid dose (< 16 mg/day vs ≥ 16 mg/day), Karnofsky performance status (≤ 80% vs > 80%), and age (≤ 50 years of age vs > 50 years of age). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients receive oral whey protein powder once daily for 7 months.
- Arm II (treatment): Patients apply topical testosterone gel to the shoulder, upper chest, or forearm once daily for 7 months.
Patients undergo strength testing and functional testing (TFT) and complete an activities of daily living questionnaire at baseline and at 1, 3, 5, and 7 months. Patients also undergo CT scan of the leg and laboratory testing at baseline and at 3 and 7 months. Testosterone levels are obtained at baseline and at 1, 3, and 7 months.
Patients complete a daily log of their glucocorticoid dose and to affirm compliance with therapy. Major clinical events related to underlying tumor (i.e., surgery, radiotherapy, initiating chemotherapy, concurrent antiepileptic therapy, deep vein thrombosis, pulmonary embolism, transfusions, seizures, pneumonia, and other forms of infection) are also recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control Group | Placebo comparator | Dietary Supplement: whey powder proteinwhey protein powder |
| ARM 2 : Treatment Group | Active comparator | Drug: testosterone gel applied to skinTestosterone Gel (10g pouch/day) applied to skin |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone gel applied to skinApplication of testosterone gel | Drug | ARM 2 : Treatment Group |
| whey powder protein | Dietary supplement | Arm 1: Control Group |
Primary outcome
Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months
Time frame: baseline and at 1, 3, 5, and 7 months
6 secondary outcomes
Muscle Strength Testing in Other Proximal Muscles (i.e., Knee Extensors, Knee Flexors, Arm Abductors, Elbow Extensors and Flexors, and Neck Flexors) as Assessed by Dynamometry at Baseline and at 1, 3, 5, and 7 Months
Time frame: baseline and at 1, 3, 5, and 7 months
Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months
Time frame: baseline and at 1, 3, 5, and 7 months
Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months
Time frame: baseline and at 3 and 7 months
Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months
Time frame: baseline and at 1, 3, 5, and 7 months
Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities
Time frame: while receiving treatment
Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months
Time frame: baseline and at 1, 3, and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaishri O. Blakeley, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing testosterone gel applied to skin and whey powder protein in people with Brain and Central Nervous System Tumors and Musculoskeletal Complications, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months (time frame: baseline and at 1, 3, 5, and 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.