Efficacy of low-dose methadone as an antitussive for patients with malignancy. A pilot study.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001061426

Enrollment

Registered

2016-08-09

Start date

2016-09-05

Completion date

2017-09-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this trial is to evaluate the safety and efficacy of methadone for the treatment of chronic cough in cancer patients in palliative care. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, suffer from chronic cough following diagnosis of cancer, and are currently in palliative care. Study details Participants enrolled in this trial will receive 3 days treatment with methadone and 3 days treatment with a placebo (sham) treatment with a no treatment day in between (total of 7 days).. The order in which these are given is randomly allocated (by chance). Each treatment period involves taking two tablets per day, and there will be a break period of 1 day between each of the two treatments. Participants will be asked to complete a number of questionnaires relating to the severity of their cough, and provide a blood sample at the end of each 3 day treatment period. It is hoped that this trial will provide information on whether methadone is a safe and effective treatment for cough in cancer patients, which may be used to inform a larger clinical trial in the future.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results