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Trial registered on ANZCTR


Registration number
ACTRN12624000345583
Ethics application status
Approved
Date submitted
26/02/2024
Date registered
26/03/2024
Date last updated
3/08/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testosterone treatment for the management of fatigue in ambulatory patients with advanced cancer: A pilot feasibility double-blind placebo-controlled study
Scientific title
Testosterone treatment for the management of fatigue in ambulatory patients with advanced cancer: A pilot feasibility double-blind placebo-controlled study
Secondary ID [1] 311330 0
075/23
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 332585 0
Fatigue 332586 0
Condition category
Condition code
Cancer 329884 329884 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327774 0
Treatment: Drugs
Comparator / control treatment
The comparator will be placebo cream with the same sensory properties as the active cream, being an almond based compound.

Participants will be instructed to apply the placebo cream, one (1) mL 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.
Control group
Placebo

Outcomes
Primary outcome [1] 337100 0
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)
Timepoint [1] 337100 0
The number of participants who complete the four-week treatment window will be assessed at 12 months post-commencement of recruitment.
Secondary outcome [1] 430707 0
Treatment completion after an 8-week period
Timepoint [1] 430707 0
8 Weeks post baseline
Secondary outcome [2] 430708 0
Change in fatigue
Timepoint [2] 430708 0
Measured at Baseline, week 2, week 4, week 8 post baseline
Secondary outcome [3] 430710 0
Change in health-related Quality of Life (QOL)
Timepoint [3] 430710 0
Baseline, week 2, week 4 and week 8 post baseline
Secondary outcome [4] 430711 0
Change in mood
Timepoint [4] 430711 0
Baseline and week 4 post baseline
Secondary outcome [5] 430712 0
Change in libido
Timepoint [5] 430712 0
Baseline, week 4, and week 8 post baseline
Secondary outcome [6] 430713 0
Change in serum testosterone levels
Timepoint [6] 430713 0
Baseline, week 4 and week 8 post baseline
Secondary outcome [7] 430714 0
Change in Hemoglobin
Timepoint [7] 430714 0
Baseline, week 4 and week 8 post baseline
Secondary outcome [8] 430715 0
Differences between groups of participant assessment of blinding
Timepoint [8] 430715 0
Week 4 post baseline or early termination or withdrawal
Secondary outcome [9] 430716 0
Difference between groups of toxicity data
Timepoint [9] 430716 0
Baseline and week 2, week 4, week 6, week 8 post baseline and weeks 1 and 2 of follow-up post treatment completion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cream will be manufactured with a matching placebo in matching tubes. The label will indicate the trial details and either treatment. The allocation label placed during manufacture will be removed by the unblinded pharmacy prior to dispensing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number table will be generated by a statistician, using blocks of 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary measure of effect for this analysis is the treatment completion rate: the proportion of all participants randomised who achieve treatment completion. We posit that further research would be warranted if the observed treatment completion rate was 80%..

A sample size of 13 evaluable participants in the experimental group provides 90% power if the true treatment completion rate is 86%, and a 1-sided type 1-error rate of 10% if the true TC rate is 55%. The treatment completion rate will be reported with 2-sided 95% confidence intervals. The rate of completion in control patients that opt into treatment after the initial study period will also be described as will treatment duration beyond 4 weeks in the intervention arm patients.

Secondary endpoints will be summarised with mean and standard deviation to enable calculations for subsequent sample sizes. Two-sided 95% confidence intervals will be reported to enable interpretation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
18/06/2024
Date of last participant enrolment
Anticipated
28/04/2025
Actual
Date of last data collection
Anticipated
7/07/2025
Actual
Sample size
Target
26
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26025 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 41871 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 315583 0
University
Name [1] 315583 0
University of Technology Sydney
Country [1] 315583 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Jones St Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 317678 0
None
Name [1] 317678 0
Address [1] 317678 0
Country [1] 317678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314479 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314479 0
Ethics committee country [1] 314479 0
Australia
Date submitted for ethics approval [1] 314479 0
28/09/2023
Approval date [1] 314479 0
02/11/2023
Ethics approval number [1] 314479 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131730 0
Dr Megan Ritchie
Address 131730 0
Concord Repatriation General Hospital, Hospital Road, Concord New South Wales 2139
Country 131730 0
Australia
Phone 131730 0
+61 400607633
Fax 131730 0
Email 131730 0
Megan.Ritchie1@health.nsw.gov.au
Contact person for public queries
Name 131731 0
Megan Ritchie
Address 131731 0
Concord Repatriation General Hospital Hospital Road, Concord New South Wales 2139
Country 131731 0
Australia
Phone 131731 0
+61 400607633
Fax 131731 0
Email 131731 0
Megan.Ritchie1@health.nsw.gov.au
Contact person for scientific queries
Name 131732 0
Megan Ritchie
Address 131732 0
Concord Repatriation General Hospital, Hospital Road, Concord New South Wales 2139
Country 131732 0
Australia
Phone 131732 0
+61 400607633
Fax 131732 0
Email 131732 0
Megan.Ritchie1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small feasibility study conducted at one site. De-identification will be very difficult and the numbers too small to be of use.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.