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

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.