A randomised, double-blind placebo controlled study of subcutaneous ketamine in the management of cancer pain

Cancer Symptom Trials (CST)

Dataset description

Dataset includes: - data for 185 participants with pain caused by cancer (93 allocated to Ketamine, 92 allocated to placebo). Treatment period over 5 days, with follow-up for 4 weeks post treatment. Data available for demographic data, primary outcome as Brief Pain Inventory score, quality of life (as EORTC QLQ -C30 and FACIT-PAL), performance status (as AKPS), opioid use, Global Impression of Change, adverse events (as NCI CTCAE V3.0), carer QOL (as Caregiver QOLC), Medicare Australia data, and survival.
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Source Study

Trial acronym

Ketamine for cancer pain

Trial ID





Phase 3


Government body,Commonwealth Department of Health and Ageing

Scientific enquiries

Prof Prof Janet Hardy

Brief Summary

This study looks at the effectiveness of the pain-killing drug ketamine in people with widespread cancer who are receiving palliative care and have difficult cancer pain that does not respond well to opioid drugs. Who is it for? You can join this study if you have widespread cancer and are receiving palliative care, and have difficult cancer pain that does not respond well to opioid (morphine-like) drugs. Trial details Participants will be divided into two groups. One group will receive five day ....
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Key Inclusion Criteria

•age >18 years •pain related to cancer or its treatment •moderate to severe pain •patients with primarily nociceptive pain (Leeds Assessment of Neuropathic Symptoms and Signs score <12), or patients with predominantly neuropathic pain (Leeds Assessment of Neuropathic Symptoms and Signs score >12) treated appropriately •stable backgound opioid dose •stable co-analgesics during the study period •patient is able to give fully informed written consent

Key Exclusion Criteria

Previous ketamine use Unstable pain, or undergoing active treatment to reduce pain (surgery, chemotherapy, radiotherapy) Medical history places patient at risk of known adverse reactions Pregnacny/ lactation Previous recreaional drug history Recent Monoamine oxidase inhibitors (non-reversible monoamine oxidase inhibitors are excluded for 4 weeks, reversible monoamine oxidase inhibitors are excluded for 2 days).

Can healthy volunteers participate?




Sample Size    150

Min. age    18 Years

Max. age    -2147483648 No limit

Sex    Both males and females

Condition category    Pain from cancer or cancer treatment

Condition code    Cancer


Intervention code Treatment: Drugs

phase III randomised, double blind, placebo controlled trial of ketamine 100mg to 300 mg then 500mg (if not responding) delivered by subcutaneous infusion over 24 hours for 5 days.


Control group Placebo

Normal Saline 15 mls, over subcutaneous infusion over 24 hours for 5 days.


Outcome: The primary outcome is the pain score on day 6.
Timepoint: Day 6

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

Primary and secondary outcome IPD Data Dictionary Protocol

When will data be available?

01/06/2023 to 01/06/2027

Available to whom?

Researchers undertaking secondary research

Available for what types of analyses?

Those analyses described in approved proposals only

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see