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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
Sponsor:
Collaborators:
Deakin University
Peter MacCallum Cancer Centre, Australia
Information provided by (Responsible Party):
Barwon Health

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Drug: Lithium
250 mg daily for 6 weeks, increased 250 - 500 mg depending on plasma levels.
Other Name: Lithicarb

No Intervention: Standard
Prophylactic cranial irradiation alone.



Primary Outcome Measures :
  1. Feasibility of a project design where the patients are randomized into lithium or placebo [ Time Frame: 1 year ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed high grade small cell neuroendocrine carcinoma.
  • Patients can either have:

    • Limited stage disease with CR or PR OR
    • Extensive stage disease with CR or good PR
  • Patients must have discontinued other chemotherapies at least 3 weeks prior to randomisation.
  • Prior radiation therapy to the chest is allowed but must be completed at least 3 weeks prior to randomisation.
  • ECOG Performance Status 0 to 2.
  • Adequate bone marrow, liver, and renal function as assessed by the following:

    • Hemoglobin ≥ 9.0 g/dl
    • Absolute neutrophil count (ANC) ≥ 1,500/mm3
    • Platelet count ≥ 100,000/mm3
    • Total bilirubin ≤ 2.0 times the upper limit of normal
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (≤ 5x ULN for patients with liver involvement)
    • International Normalized Ratio for Prothrombin Time (PT-INR) ≤ 1.5 and activated partial prothrombin time (aPTT) within 5% of normal limits for patient NOT on anticoagulation.
    • Estimated Glomerular Filtration Rate (eGRF) > 50 ml/min .
  • Male or female aged >18 years
  • Patients must be able and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
  • Patients must be able to swallow and retain oral medication.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomisation and must agree to use adequate contraception prior to randomisation and for the duration of study participation.

Exclusion Criteria:

  • Life expectancy less than 3 months.
  • Substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.
  • Severe cardiac or renal disease.
  • Frank hypothyroidism.
  • Hyponatraemia.
  • Known or suspected allergy to lithium.
  • Women who are pregnant or breast-feeding.
  • Inability to comply with protocol and /or not willing or not available for follow-up assessments.
  • Significant psychiatric or neurologic illness (prior known psych/cognitive/CNS pathology eg CVA; known or prior brain metastases
  • Current lithium therapy.

Information from the National Library of Medicine

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


Locations
Australia, Victoria
Barwon Health
Geelong, Victoria, Australia, 3220
Peter MacCallum Cancer Centre
Moorabbin, Victoria, Australia, 3189
Sponsors and Collaborators
Barwon Health
Deakin University
Peter MacCallum Cancer Centre, Australia
Investigators
Principal Investigator: Mustafa Khasraw, MD Barwon Health

Responsible Party: Barwon Health
ClinicalTrials.gov Identifier: NCT01486459     History of Changes
Other Study ID Numbers: ALCC 11.01
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: August 2013

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lithium Carbonate
Neuroprotective Agents
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Protective Agents