Testosterone treatment for the management of fatigue in ambulatory patients with advanced cancer: A pilot feasibility double-blind placebo-controlled study
University of Technology Sydney
26 participants
Jun 18, 2024
Interventional
Conditions
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
Inclusion Criteria7
- Adult men and women with advanced cancer, solid organ or haematopoietic malignancy
- years or older
- The Palliative Care Outcome Collaboration (PCOC) Symptom Assessment Score (SAS) of 3 or greater for fatigue
- Australia - modified Karnofsky Performance Status Palliative Score of 40 or above
- Able to give informed consent as determined by the treating clinician
- Able to complete study procedures and comply with study procedures
- No indication of primary hypogonadism on the completion of the screening reproductive function questionnaire
Exclusion Criteria9
- Advanced prostate carcinoma, or current diagnosis of prostate carcinoma receiving active hormonal therapy.
- Baseline erythrocytosis (haematocrit >50%)
- Primary male hypogonadism
- Previous adverse reaction to Testosterone Treatment
- Pregnant or breastfeeding
- AKPS of 30 or below.
- Patients with advanced breast carcinoma if the treating Oncologist objects
- Allergy or hypersensitivity to Almond oil or tree nuts.
- Unable to give informed consent.
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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.
Locations(1)
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ACTRN12624000345583