RecruitingPhase 2Phase 3ACTRN12624000345583

Testosterone treatment for the management of fatigue in ambulatory patients with advanced cancer: A pilot feasibility double-blind placebo-controlled study

Sponsor

University of Technology Sydney

Enrollment

26 participants

Start Date

Jun 18, 2024

Study Type

Interventional

Conditions

Cancer Fatigue

Summary

This study is determining whether a testosterone cream is a feasible treatment for the management of fatigue in patients with advanced cancer. Who is it for? You may be eligible for this study if you are an adult male or female with advanced cancer, solid organ or haematopoietic malignancy. Fatigue questionnaires will also be used to evaluate suitability for this study. Study details Participants will be randomly assigned to apply either testosterone or placebo cream topically daily for 4 weeks. There will also be an optional extension period where all participants will be given testosterone cream for a further 4 weeks. Treatment completion will be analysed, and participants will be asked to provide blood samples and complete questionnaires on their fatigue and quality of life. It is hoped that findings from this study will help inform researchers of the feasibility of conducting a larger study examining the impact of this testosterone treatment for advanced cancer patients.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Fatigue is one of the most common and distressing symptoms experienced by people living with advanced cancer. It can make everyday activities feel overwhelming and significantly reduce quality of life. Testosterone — a hormone naturally found in both men and women — plays a role in energy, muscle strength, and vitality, and may potentially help manage cancer-related fatigue. This pilot study from the University of Technology Sydney is testing whether a daily testosterone cream (applied to the skin) is a feasible and potentially effective way to manage fatigue in people with advanced cancer. Half the participants will receive real testosterone cream, and half will receive a placebo cream, for 4 weeks. There is also an optional 4-week extension where all participants receive testosterone. You may be eligible if you are a man or woman aged 18 or older with advanced cancer (solid organ or blood cancer), have significant fatigue (scoring 3 or more on a 0-10 symptom scale), and are mobile enough to manage daily activities. People with advanced prostate cancer on hormone therapy, high red blood cell counts, or allergies to almond oil are not eligible. This compassionate study is focused on finding ways to meaningfully improve how patients with advanced cancer feel day to day.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The Intervention is a topical testosterone cream (Androforte 50mg/ml or Androfeme 10mg/ml) vs a placebo cream. All participants will be randomised at a 1:1 ratio for the application of topical testosterone vs placebo cream daily for 4 weeks. Male participants will be allocated Androforte 50mg/ml or placebo and female participants will be allocated Androfeme 10mg/ml or placebo. Participants will be instructed to apply one (1) mL of the cream daily, at the same time each morning within a two hour window. One (1) ml of cream is applied to the scrotum in men; and to the upper thigh, buttocks or upper torso over intact skin in women. After applying the cream, hands should be thoroughly washed. No showering, swimming or physical skin-to-skin contact with application site unless covered with clothing for 4 hours post application. The total duration of treatment is 4 weeks. Participants will be required to keep the cream tubing to enable compliance to be checked, and all tubes will be returned to the dispensing pharmacy. To further assess compliance participants will also maintain a diary of application, and will be asked at each study contact. At the end of the 4 weeks treatment, each participant will be offered a 4 week open label extension of testosterone treatment.