Ketamine for Cancer Pai

Phase 1

Completed

• Conditions: Inadequate analgesia; Cancer - Any cancer; Advanced Cancer; Moderate to Severe Pain; Anaesthesiology - Pain management

• Registration Number: ACTRN12621000328875
• Lead Sponsor: Chris O'brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-23
• Study Completion: 2023-03-21
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1.Adult patients with diagnosis of advanced cancer
2.Weight >40 kg, and BMI between 18-40 kg•m-2
3.Moderate to severe pain associated with the cancer diagnosis requiring ongoing opioid analgesia at >60 mg of OMEDD (oral morphine equivalent daily dose)
4.Self-reporting sub-optimal pain control with current analgesia
5.Willingness to provide informed consent and willingness to participate and comply with the study requirements.

Exclusion Criteria

1.Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2.Participants who are receiving ketamine medication through any route of administration as part their treatment regimen.
3.Participants with a history of raised intra-cranial pressure, epilepsy, raised intra-ocular pressure, severe cardiac failure, or uncontrolled hypertension
4.Participants with a history of cognitive impairment which may interfere with their ability to understand the study requirements.
5.Participants with DSM-V diagnosis of psychotic disorders or dissociative disorders which may resemble the adverse effect of the study medication
6.The requirement of analgesia is expected to decrease following recruitment into the study.
7.Participants with life expectancy of less than six weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of two cycles in thirty participants over 12 month period with the existing resource.<br>i.e. less than 25 % attrition rate<br><br>This will be assessed by the project staff at the end of each seven-day period through videoconferencing appointment. <br>Assessment will consist of:<br>- visual inspection of the medication pack to confirm the number of the medication consumed and medication left. <br>- collection of the study diary, Quality of Life Questionnaire (AQol-6D), and Drug Efficacy Questionnaire (including SAT-1 (Self-assessment of treatment-1))[ Twelve months period after commencement of the study]