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Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain

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ClinicalTrials.gov Identifier: NCT01553916
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : November 8, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Small Cell Lung Carcinoma
Interventions: Drug: Lithium Carbonate
Radiation: Prophylactic cranial irradiation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.


Participant Flow:   Overall Study
    Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
STARTED   19 
COMPLETED   16 
NOT COMPLETED   3 
Withdrawal by Subject                2 
Pre-treatment MRI metastatic disease                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.


Baseline Measures
   Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Years]
Median (Full Range)
 58 
 (49 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  63.2% 
Male      7  36.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   19 


  Outcome Measures

1.  Primary:   Safety of Lithium Carbonate as Measured by Number of Patients in the Safety lead-in Who Experienced a Dose-limiting Toxicity (DLT)   [ Time Frame: 3 weeks ]

2.  Primary:   Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score   [ Time Frame: 3 months ]

3.  Secondary:   Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score   [ Time Frame: 6 months ]

4.  Secondary:   Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score   [ Time Frame: 12 months ]

5.  Secondary:   Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score   [ Time Frame: 3 months ]

6.  Secondary:   Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score   [ Time Frame: 6 months ]

7.  Secondary:   Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score   [ Time Frame: 12 months ]

8.  Secondary:   Changes in Quality-of-life as Measured by Overall Quality of Life Using the EORTC QLQ30   [ Time Frame: 3 months ]

9.  Secondary:   Changes in Quality-of-life as Measured by Overall Quality of Life Using the Total Score of the EORTC QLQ-BN20   [ Time Frame: 12 months ]

10.  Secondary:   Feasibility of Performing Serial Neurocognitive Testing and Quality of Life Exams as Measured by Number of Patients Who Complete the Neurocognitive Testing and Quality of Life Exams   [ Time Frame: 3 months ]

11.  Secondary:   Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume   [ Time Frame: Baseline through 12 months ]

12.  Secondary:   Number of Participants With Brain Metastases   [ Time Frame: 12 months ]

13.  Secondary:   Number of Central Nervous System (CNS) Adverse Events   [ Time Frame: Through 12 months ]

14.  Secondary:   Rate of Overall Survival   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Clifford Robinson, M.D.
Organization: Washington University School of Medicine
phone: 314-362-4653
e-mail: clifford.robinson@wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01553916     History of Changes
Other Study ID Numbers: 201202073
First Submitted: March 12, 2012
First Posted: March 14, 2012
Results First Submitted: September 7, 2017
Results First Posted: November 8, 2017
Last Update Posted: July 4, 2018