A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer (TULIP)
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|ClinicalTrials.gov Identifier: NCT01486459|
Recruitment Status : Terminated (Insufficient recruits)
First Posted : December 6, 2011
Last Update Posted : March 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Lithium||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2014|
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.
- Feasibility of a project design where the patients are randomized into lithium or placebo [ Time Frame: 1 year ]Number of participants with adverse events
- Neurocognition [ Time Frame: 1 year ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486459
|Geelong, Victoria, Australia, 3220|
|Peter MacCallum Cancer Centre|
|Moorabbin, Victoria, Australia, 3189|
|Principal Investigator:||Mustafa Khasraw, MD||Barwon Health|