Testosterone Gel for Cancer-Related Fatigue

(TEMEC Trial)

Recruiting at 3 trial locations

Overseen By Jose Garcia, MD, Phd

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Seattle Institute for Biomedical and Clinical Research

Must not be taking: Anabolic agents

Disqualifiers: Prostate cancer, Sleep apnea, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 months

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether testosterone gel can reduce fatigue in older men with cancer. It compares the gel's effectiveness to a placebo for men with low testosterone levels experiencing fatigue from cancer treatments. Suitable candidates are men over 55 who have undergone treatments like chemotherapy or radiation and feel unusually tired. Participants will apply either the testosterone gel or a placebo gel daily for six months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using anabolic agents like testosterone, DHEA, or growth hormone, you must have stopped them at least 6 months before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that testosterone replacement therapy is usually well-tolerated. The TRAVERSE study found that testosterone therapy did not increase the risk of major heart problems compared to a placebo, suggesting that the treatment is safe for the heart.

Another study found that testosterone injections helped cancer patients maintain muscle mass without causing major issues. However, the long-term effects on heart health in older men with low testosterone remain unclear.

In summary, current studies suggest that testosterone gel is safe for most people, but monitoring for possible side effects is important. As with any treatment, discussing potential risks with a doctor is crucial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using testosterone gel for cancer-related fatigue because it introduces testosterone directly into the body, potentially addressing fatigue by boosting energy levels and improving muscle strength. Unlike typical treatments that may focus on diet changes or exercise to manage fatigue, this gel offers a hormone-based approach that could work more directly on the body's energy systems. The gel's topical application is also a unique feature, providing a non-invasive, easy-to-use method that could improve patient compliance compared to oral medications or injections.

What evidence suggests that testosterone gel might be an effective treatment for cancer-related fatigue?

Research shows that testosterone replacement therapy can reduce cancer-related tiredness in men. Studies have found that testosterone therapy prevents weight loss in patients with certain cancers, such as cervical or head and neck cancer. Maintaining a healthy weight may boost energy levels and overall strength. Testosterone replacement has also improved the quality of life in male cancer survivors by reducing fatigue. In this trial, participants will receive either testosterone 1.62% gel or a placebo gel. These findings suggest that testosterone gel could effectively manage tiredness in men with low testosterone levels who are dealing with cancer. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Men aged 55+ with incurable lung or colorectal cancer, experiencing fatigue and low testosterone levels after chemo/radiation therapy. They should have a life expectancy of at least 6 months, not be severely ill from other conditions, and must consent to participate.

Inclusion Criteria

I often feel very tired, more than usual.

I am a man with lung or colorectal cancer, treated with chemo or radiation, and have been NED for less than 24 months.

My testosterone levels are low, below the normal range.

Exclusion Criteria

I have a genetic condition that causes blood clots.

Body mass index (BMI) >40 kg/m2

I am not taking any glucocorticoids, except as part of chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments and training on gel application procedures

1 day

1 visit (in-person)

Treatment

Participants receive testosterone or placebo gel for 6 months with dose adjustment and monitoring

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Gel
• Testosterone 1.62% Gel

Trial Overview

The trial is testing if testosterone gel improves fatigue in older men with cancer compared to a placebo. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real treatment until the end.

How Is the Trial Designed?

Group I: testosterone 1.62% gel Experimental Treatment 1 Intervention

Testosterone 1.62% gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.

Group II: placebo gel Placebo Group 1 Intervention

The placebo gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

Published Research Related to This Trial

In a pilot study of 18 men with eugonadotropic hypogonadism, transdermal testosterone gel treatment for 3 months successfully normalized testosterone levels without negatively affecting sperm production.

This suggests that testosterone gel therapy could be a promising option for treating hypogonadism in reproductive-aged men while preserving fertility, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of testosterone gel treatment on spermatogenesis in men with hypogonadism. George, M., Yulia, T., Svetlana, K.[2014]

Testosterone gel 2% (TG) was found to be effective in increasing serum testosterone levels in hypogonadal men, with an 85.5% responder rate after 3 months of treatment in a study involving 180 participants.

The safety profile of TG was acceptable, with fewer subjects experiencing high testosterone levels (Cmax >1500 ng/dl) in the extension study, and no significant safety concerns were noted, including no notable increases in prostate-specific antigen or haematocrit levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. Belkoff, L., Brock, G., Carrara, D., et al.[2018]

In a study of seven men who underwent orchidectomy for testicular cancer, intramuscular testosterone injections led to a significant drop in plasma testosterone levels, with levels falling below the normal range before the next injection.

Despite fluctuations in testosterone levels, sexual functioning was not directly affected; however, some patients reported psychological and physical side effects, such as loss of libido and mood changes, particularly towards the end of the injection interval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual functioning in testosterone-supplemented patients treated for bilateral testicular cancer. van Basten, JP., van Driel, MF., Jonker-Pool, G., et al.[2019]

Testosterone gel formulations effectively restore testosterone levels to mid-normal physiological ranges within 24 hours, improving the quality of life for patients with hypogonadism.

While testosterone gels have a favorable efficacy and safety profile compared to other forms of testosterone replacement therapy, there is a risk of secondary exposure, which remains a challenge for their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new 2% testosterone gel formulation: a comparison with currently available topical preparations. Arver, S., Stief, C., de la Rosette, J., et al.[2019]

In a study of 149 hypogonadal men, the novel testosterone 2% gel (Fortesta™ Gel) effectively restored testosterone levels to the normal range in 77.5% of patients after 90 days, demonstrating its efficacy as a testosterone replacement therapy.

The gel was generally well tolerated, with mild to moderate skin reactions being the most common side effects, and only 1.6% of patients experienced testosterone levels that were higher than the recommended range, indicating a low risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel testosterone 2% gel for the treatment of hypogonadal males. Dobs, AS., McGettigan, J., Norwood, P., et al.[2013]

In a randomized, double-blind, placebo-controlled trial involving 29 hypogonadal males with advanced cancer, testosterone replacement did not show a significant improvement in fatigue scores after 29 days, indicating limited immediate efficacy for this symptom.

However, by day 72, testosterone treatment was associated with significant improvements in sexual desire and performance status, suggesting potential longer-term benefits that warrant further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: a preliminary double-blind placebo-controlled trial. Del Fabbro, E., Garcia, JM., Dev, R., et al.[2021]

The Testosterone Trials were designed as a coordinated set of seven clinical trials to definitively assess the efficacy of testosterone treatment in elderly men with low testosterone levels, focusing on various health aspects such as mobility, sexual function, and cognitive abilities.

The trials aimed to improve the reliability of results by using common eligibility criteria and treatment approaches, although the rigorous screening process required evaluating about 30 men to enroll just one participant, ensuring that only those with unequivocally low testosterone were included.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Testosterone Trials: Seven coordinated trials of testosterone treatment in elderly men. Snyder, PJ., Ellenberg, SS., Cunningham, GR., et al.[2021]

In a study involving 24 cancer patients, testosterone therapy did not significantly reduce cancer-related fatigue (CRF) symptoms or improve inflammatory markers compared to placebo.

Despite previous findings that testosterone preserved lean body mass, this treatment did not enhance health-related quality of life or functional performance in late-stage cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Adjunct Testosterone on Cancer-Related Fatigue: An Ancillary Analysis from a Controlled Randomized Trial. McGovern, KA., Durham, WJ., Wright, TJ., et al.[2023]

A study involving 16 men with androgen deficiency found that a novel 5% testosterone cream (AndroForte 5) and a 1% testosterone gel (Testogel) were bioequivalent, meaning they had similar pharmacokinetic profiles after 30 days of treatment.

Both testosterone formulations did not show significant differences in secondary biochemical markers, indicating that they have comparable safety and efficacy profiles for treating testosterone deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101. Wittert, GA., Harrison, RW., Buckley, MJ., et al.[2016]

In a study involving 26 healthy male volunteers, applying 5.0 g of a 2.5% testosterone gel daily for 10 days successfully restored physiological testosterone levels, while 2.5 g was insufficient for this purpose.

Washing the gel off 10 minutes after application did not affect testosterone absorption, which helps minimize the risk of contamination for female partners or infants, enhancing the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a new transdermal testosterone gel in gonadotrophin-suppressed normal men. Rolf, C., Kemper, S., Lemmnitz, G., et al.[2019]

Topical testosterone gels can lead to unintentional transfer of testosterone to women and children through skin contact, which may result in conditions like female hyperandrogenism, as illustrated by a reported case.

Research, including case reports and clinical trials, confirms that testosterone transfer from gel-treated males is a clinically relevant risk, highlighting the need for awareness of this potential side effect in testosterone replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperandrogenism after transfer of topical testosterone gel: case report and review of published and unpublished studies. de Ronde, W.[2022]

Citations

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Here, we report novel findings that testosterone therapy prevented loss of body mass in patients with cervical or head and neck cancer undergoing standard of ...

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This study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue.

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Clinical Research Study for Male Cancer Survivors with ...

Testosterone replacement therapy may improve these symptoms in cancer survivors which may result in improvement in qualify of life. What we hope to accomplish.

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Male patients with hypogonadism receiving oral testosterone undecanoate 225 mg twice daily demonstrated improvements in libido and sexual frequency.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9689748/

Impact of Adjunct Testosterone on Cancer-Related Fatigue

Seven weekly injections of 100 mg adjunct testosterone preserved lean body mass in cancer patients undergoing standard-of-care treatment in a hospital setting.

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nejm.org

nejm.org/doi/full/10.1056/NEJMoa2215025

Cardiovascular Safety of Testosterone-Replacement Therapy

The cardiovascular safety of testosterone-replacement therapy in middle-aged and older men with hypogonadism has not been determined.

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TRAVERSE Study Supports Cardiovascular Safety of ...

Testosterone replacement therapy was not associated with an increase in major adverse cardiovascular events compared with placebo in the large TRAVERSE study.