Not Yet RecruitingPhase 4ACTRN12616001061426

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


Sponsor

Monash Health

Enrollment

40 participants

Start Date

Sep 5, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • 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 Criteria5

  • 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

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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

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.


Locations(1)

VIC, Australia

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ACTRN12616001061426