A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer (TULIP)
Small cell lung cancer is an aggressive neuroendocrine tumour that often presents with extensive (metastatic) disease. Chemotherapy is the mainstay of treatment, with radiotherapy to the primary tumour. It is now part of care to also offer Prophylactic Cranial Irradiation (PCI) in order to prevent spread of the cancer into the brain.
Cognitive impairment can result after cranial irradiation. Lithium is thought to be neuroprotective. It is hypothesized that lithium administration with PCI will be safe, tolerable and feasible, and can be studied to prevent or ameliorate the ensuing cognitive impairment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer|
- Feasibility of a project design where the patients are randomized into lithium or placebo [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Number of participants with adverse events
- Neurocognition [ Time Frame: 1 year ] [ Designated as safety issue: No ]Measurements of CogState, Cognitive Failures Questionnaire, CES-D and somnolence syndrome using the Epworth Sleepiness Scale in patients treated with lithium compared to the controls
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: PCI with lithium
Prophylactic cranial irradiation Lithicarb® tablets 250mg/day for 6 weeks. Initial dosing will be 250mg given once daily, and increased by 250 - 500 mg increments depending on plasma levels.
250 mg daily for 6 weeks, increased 250 - 500 mg depending on plasma levels.
Other Name: Lithicarb
No Intervention: Standard
Prophylactic cranial irradiation alone.
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|Contact: Mustafa Khasraw, MD||+61-3-4215 firstname.lastname@example.org|
|Geelong, Victoria, Australia, 3220|
|Contact: Mustafa Khasraw email@example.com|
|Principal Investigator: Mustafa Khasraw, MD|
|Peter MacCallum Cancer Centre||Recruiting|
|Moorabbin, Victoria, Australia, 3189|
|Contact: Greg Wheeler, MBBS +61-3-96561111 Greg.Wheeler@petermac.org|
|Principal Investigator: Greg Wheeler, MBBS|
|Principal Investigator:||Mustafa Khasraw, MD||Barwon Health|