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

Phase 2

Recruiting

• Conditions: Cancer; Fatigue; Cancer - Other cancer types

• Registration Number: ACTRN12624000345583
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-26
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Adult men and women with advanced cancer, solid organ or haematopoietic malignancy
18 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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to determine feasibility of the study to conduct a further definitive Phase III randomized control trial (RCT). This is determined by the ability to recruit 26 participants within 12 months as well as Treatment Completion (TC) [Defined as the percentage of randomised participants who complete the four-week treatment window, this must be at least 80% of randomized participants. 60% or less would be considered unacceptable.<br><br>Completion will be measured from the participant diary of treatment compliance. Complete diaries from 26 participants will be required in order to meet the primary objective. The number of participants who complete the four-week treatment window will be assessed at 12 months post-commencement of recruitment.]