A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer (TULIP)
This study is currently recruiting participants.
Verified November 2012 by Barwon Health
Sponsor:
Barwon Health
Collaborators:
Deakin University
Peter MacCallum Cancer Centre, Australia
Information provided by (Responsible Party):
Barwon Health
ClinicalTrials.gov Identifier:
NCT01486459
First received: December 4, 2011
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
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 | Intervention |
|---|---|
|
Small Cell Lung Cancer |
Drug: Lithium |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Barwon Health:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 20 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed SCLC
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.
- Creatinine ≤ 2.0 times the upper limit of normal. Patients with ECOG performance score 2 are ineligible if serum albumin is < 30 g/L.
- Age ≥ 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486459
Contacts
| Contact: Mustafa Khasraw, MD | +61-3-4215 2764 | m.khasraw@deakin.edu.au |
Locations
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | Not yet recruiting |
| East Melbourne, Victoria, Australia, 3002 | |
| Contact: Greg Wheeler, MBBS +61-3-96561111 | |
| Principal Investigator: Greg Wheeler, MBBS | |
| Barwon Health | Recruiting |
| Geelong, Victoria, Australia, 3220 | |
| Contact: Mustafa Khasraw m.khasraw@deakin.edu.au | |
| Principal Investigator: Mustafa Khasraw, MD | |
Sponsors and Collaborators
Barwon Health
Deakin University
Peter MacCallum Cancer Centre, Australia
Investigators
| Principal Investigator: | Mustafa Khasraw, MD | Barwon Health |
More Information
No publications provided
| Responsible Party: | Barwon Health |
| ClinicalTrials.gov Identifier: | NCT01486459 History of Changes |
| Other Study ID Numbers: | ALCC 11.01 |
| Study First Received: | December 4, 2011 |
| Last Updated: | November 13, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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 Lithium Carbonate Neuroprotective Agents |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013