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Trial registered on ANZCTR


Registration number
ACTRN12616001061426p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2016
Date registered
9/08/2016
Date last updated
9/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of low-dose methadone as an antitussive for patients with malignancy. A pilot study.
Scientific title
Efficacy of low-dose methadone as an antitussive for patients with malignancy. A pilot study.
Secondary ID [1] 289528 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cough in malignancy 299235 0
Condition category
Condition code
Cancer 299245 299245 0 0
Any cancer
Respiratory 299259 299259 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised 1:1 to receive either methadone 5mg twice daily (oral tablet) or placebo twice daily (oral tablet) from Day 1 to Day 3, followed by a single day washout period (Day 4), and then swapping to the alternative (placebo or methadone) for three days (Day 5 to Day 7). Adherence monitored by empty drug packet return.
Intervention code [1] 295118 0
Treatment: Drugs
Comparator / control treatment
Microcellulose (tablet)
Control group
Placebo

Outcomes
Primary outcome [1] 298728 0
The proportion of patients with a clinically significant reduction in cough as evidenced by a drop in mean Leister Cough Quenstionnaire (LCQ) of 1.3 or in mean Cough Visual Analogue Scale (VAS) by 8 mm
Timepoint [1] 298728 0
Baseline, End of Day 3, Start of Day 5, end of Day 7
Primary outcome [2] 299017 0
Proportion of participants with an improvement in Quality of life by drop on mean leister Cough Quenstionairre and Cough Visual analgoue scale
Timepoint [2] 299017 0
Baseline, End Day 3, Start Day 5, end Day 7
Secondary outcome [1] 325079 0
Safety of adding low dose methadone to patients' existing medications as an antitussive. Physical examination and documentation of adverse events as per CTCAE v3.
Risks of Methadone
The known risks of this study which are principally related to methadone use are:

Common (greater than 1 in 100 patients)
Nausea
Vomiting
Dry mouth
Constipation
Dizziness
Fatigue
Light-Headedness
Sweating
Confusion
Respiratory depression (Hypoventilation)
Hallucinations
Psychiatric effects including euphoria, hypomania, and behaviour disturbances

Infrequent (between 1 in 100 and 1 in 1000 patients):
Inflammation of the tongue (Glossitis)
Loss of strength or weakness
Low blood pressure (Hypotension)
Low body temperature (Hypothermia)
Collapse
Swelling (Oedema)
Spasm of the renal tract

Rare (less than 1 in 1000 patients):
Abdominal pain
Lack of appetite (Anorexia)
Biliary tract spasm
Anaphylaxis
Agitation
Insomnia
Mood Changes
Heightened state of restlessness (Dysphoria)
Changes to the electrical and muscular functions of the heart.
Enlargement of Breasts in Men (Gynaecomastia) - only with prolonged use
Timepoint [1] 325079 0
Day 7 following first dose of first study treatment
Secondary outcome [2] 325080 0
Explore patients' current knowledge level and attitudes to methadone as a palliative medication and compare that with morphine and other opiods. Patients will be given a single structured survey to complete at the time of recruitment with regards to their attitudes to opioids. This will be a survey custom designed for this study.
Timepoint [2] 325080 0
Day 7 following first dose of first study treatment
Secondary outcome [3] 325081 0
Examine patients' methadone plasma levels at end of treatment and determine if plasma level correlates with antitussive effect.Correlation between plasma methadone and antitussive effect as assessed by the LCQ and VAS.
Timepoint [3] 325081 0
A blood sample will be collected at Day 7 following first dose of first study treatment

Eligibility
Key inclusion criteria
Screening ESAS (Edmonton Symptom Assessment Score administered as per standard Monash Supportive and Palliative Care Unit practice) of cough score of four or more
Able to give informed consent
English speaking
Malignancy requiring palliative care
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently receiving systemic anticancer treatment including:
Any systemic cytotoxic chemotherapy or targeted therapy
Any radiotherapy to thorax within the past month
Known allergy or sensitivity to opioids
Any increase or commencement of corticosteroids within the last three days

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was calculated by using previous reports of LCSS scores in patients with chronic cough. The predicted standard deviation of the LCCS was 2.8 points. Previous studies have shown that a -1.3 point difference in pre- and post-treatment LCCS scores to be clinically significant. To provide 80% power to detect this 1.3 difference (if 10% dropout rate, two-sided testing and a required a value of <0.05 is assumed), 40 patients will be required.
Visual Analogue Scale of 0-100mm. The predicted standard deviation being 16mm. 40 participants would provide 80% power to detect a clinically significant difference of 8mm in the scale with an a of 0.05 allowing for a 10% dropout rate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2016
Actual
Date of last participant enrolment
Anticipated
4/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13443 0
3168 - Clayton
Recruitment postcode(s) [2] 13444 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 13445 0
3175 - Dandenong
Recruitment postcode(s) [4] 13446 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 293905 0
Charities/Societies/Foundations
Name [1] 293905 0
Bethlehem Griffiths Research Foundation
Country [1] 293905 0
Australia
Primary sponsor type
Government body
Name
Monash Health
Address
246 Clayton Rd Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 292729 0
None
Name [1] 292729 0
Address [1] 292729 0
Country [1] 292729 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295321 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 295321 0
Ethics committee country [1] 295321 0
Australia
Date submitted for ethics approval [1] 295321 0
02/06/2016
Approval date [1] 295321 0
Ethics approval number [1] 295321 0

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

Contacts
Principal investigator
Name 66878 0
A/Prof Michael Franco
Address 66878 0
Monash Health
865 Centre Rd East Bentleigh VIC 3165
Country 66878 0
Australia
Phone 66878 0
+61 3 9928 8120
Fax 66878 0
+613 9928 8341
Email 66878 0
michael.franco@monashhealth.org
Contact person for public queries
Name 66879 0
Michael Franco
Address 66879 0
Monash Health
865 Centre Rd East Bentleigh VIC 3165
Country 66879 0
Australia
Phone 66879 0
+61 3 9928 8120
Fax 66879 0
+613 9928 8341
Email 66879 0
michael.franco@monashhealth.org
Contact person for scientific queries
Name 66880 0
Michael Franco
Address 66880 0
Monash Health
865 Centre Rd East Bentleigh VIC 3165
Country 66880 0
Australia
Phone 66880 0
+61 3 9928 8120
Fax 66880 0
+613 9928 8341
Email 66880 0
michael.franco@monashhealth.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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