Neoplasms

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Carcinoma

Carcinoma, Neuroendocrine

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Lithium Carbonate

Antidepressive Agents

Enzyme Inhibitors

Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.2; Continue until progressive disease/unacceptable toxicity; Evaluate every 4 weeks.

Lithium carbonate

Herbert Chen, MD

Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate

An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

University of Wisconsin, Madison

Adverse events (AEs) were reported routinely at scheduled times during the trial. Additionally, some adverse events were reported in an expedited manner for more timely monitoring of patient safety and care. The serum lithium level was checked after 4-5 days of treatment by blood sample prior to daily dose 1 of lithium. If lithium level was outside the 0.8-1.2 mmol/L range, lithium levels were monitored weekly for 4 weeks and monthly after 4 weeks.

AEs grades range from 1 (mild) to 5 (death).

Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.

Lithium Capsules

< 50 years of age

50-59 years of age

60-69 years of age

> 69 years of age

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This study enrolled participants with Medullary Thyroid Cancer (MTC).

Director of Clinical Research

No data was ever analyzed, resulted, or published on this study.

Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Oral lithium carbonate dose escalation: Level 1 of 600 mg/day, then escalating to Level 2 of 900 mg/day, then the final Level 3 of 1200 mg/day.

Moben Mirza, MD

Laboratory testing has suggested that lithium may decrease the incidence of certain types of cancer, including prostate cancer. Additional research has suggested that lithium decreases prostate cancer tumor size over time. This study will investigate the effect of lithium on men with prostate cancer.

As lithium has been shown in an in vitro model to suppress cellular proliferation, and suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot study we plan to assess the toxicity of lithium administration in patients prior to radical prostatectomy. This will include any clinical toxicity as well as any increase in intra-, peri- or postoperative complications.

Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer

Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.

To evaluate tumor response by lithium concentration in the surgically removed prostate and serum PSA levels.

To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.

To document observed levels of lithium in the serum

University of Kansas Medical Center

Anti-Infective Agents

Trichostatin A

Lithium carbonate will be dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate will be provided as a 300mg tablet and will be taken daily without breaks in treatment.

Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every 8 weeks.

Noelle LoConte, MD

The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.

Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks.

Lithium for Low-Grade Neuroendocrine Tumors

A Phase II Clinical and Biological Study of Lithium Carbonate in Patients With Low-Grade Neuroendocrine Tumors

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.

Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression. If a participant did not experience an event of disease progression or death at the time of analysis (03/10/2011), then the patient's data was censored at the date of the last available evaluation.

Overall survival for a participant is defined as the number of days from the day of first Lithium administration to the participant's death. As of the time of analysis (03/10/2011), median overall survival duration was not reached.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

Lithium

Age, Categorical

Participants with histologically confirmed metastatic low-grade neuroendocrine neoplasms were enrolled.

Dr. Noelle LoConte

Complete Response (CR)

Partial Response (PR)

Progressive Disease (PD)

Stable Disease (SD)

Progression Free Survival (PFS)

Overall Survival (OS)

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Neuroprotective Agents

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.

Mustafa Khasraw, MD

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.

Small cell lung cancer (SCLC) is an aggressive neuroendocrine tumour that often presents with extensive (metastatic) disease.\[1\] It frequently has micrometastatic disease at presentation. Chemotherapy is the mainstay of treatment with radiotherapy to the primary tumour. It is now part of care to offer Prophylactic Cranial Irradiation (PCI)with 25 Gy in 10 fractions dependent on the extent of response in the primary tumour and the patient's performance status. PCI is routine care for limited stage patients showing response and can be considered in selected patients with limited stage disease showing good response.Somnolence syndrome is a common intermediate side effect of cranial radiotherapy that occurs about six weeks after treatment and manifests as lethargy, increased sleepiness and poor attention or subtle memory changes and altered temperament\[2\].

The use of cranial irradiation is linked to neurocognitive complications such as long term memory, mood and concentration issues\[3\]. Decline in attention, executive function, motor, language and general intellectual skills have all been reported. There is the suggestion of a more rapid progression of dementing illness in patients receiving cranial irradiation although the numbers of long term survivors is limited\[3\]. Radiation mediates neurocognitive effects by affecting glial cells, neural stem and progenitor cells\[4, 5\] and the vascular structures\[3, 6\]. Cranial irradiation delivered to mice has been shown to reduce neural proliferation translating to long term reduction in neurogenesis\[7, 8\]. Lithium confers neuroprotection and is associated with less cognitive loss in various brain injury models including after cranial irradiation\[9, 10\]. In addition, neural stem/progenitor cells positively respond to Lithium treatment under basal conditions\[11, 12\]. In humans, 4 weeks of Lithium increases brain grey matter content\[13\] and hippocampal volume\[14\] as evidenced by MRI scanning. Lithium was found to protect irradiated hippocampal neurons in mice from apoptosis resulting in better performance reflecting learning and memory function\[10\]. Lithium is known to reduce oxidative stress, specifically via the glutathione system. Lithium is a standard part of the management of moderate to severe bipolar disorder and schizoaffective disorders and its toxicity profile is well understood\[15, 16\]. In bipolar disorder, lithium has been shown to prevent the loss of cortical grey matter that occurs as part of the neuroprogressive cascade seen in the disorder\[17\]. There is limited prospective clinical data regarding the use of lithium as a neuroprotectant. A large Danish observational cohort study, demonstrated that use of lithium (in those with mood disorders, who display an increased risk for dementia) was associated with reduction of the rate of dementia to the same level as that for the general population\[18\]. A follow up study by the same group showed similar findings\[19\]. A metaanalysis of lithium on cognitive performance demonstrated minor negative effects on cognition\[20\]. There has been one early phase study using lithium as a neuroprotective agent presented in abstract form at the 2007 American Society for Therapeutic Radiology and Oncology (ASTRO)\[21\] and updated at the 2008 annual meeting of the Society of NeuroOncology (SNO)\[22\].

Long term lithium treatment has also shown promise in amnestic mild cognitive impairment in a study that randomized 45 participants to receive lithium (0.25-0.5 mmol/l) (n = 24) or placebo (n = 21) in a 12 month, doubleblind trial\[23\]. Lithium treatment was associated with a significant decrease in CSF concentrations of Ptau(P =0.03) and better performance on the cognitive subscale of the Alzheimer's Disease Assessment Scale and in attention tasks. The data support the notion that lithium has disease modifying properties with potential clinical implications in the prevention of Alzheimer's disease.\[23\]

References:

1. Turrisi AT, 3rd, Kim K, Blum R et al. Twice daily compared with once daily thoracic radiotherapy in limited small cell lung cancer treated concurrently with cisplatin and etoposide. N England J Med 1999; 340: 265271.
2. Kelsey CR, Marks LB. Somnolence syndrome after focal radiation therapy to the pineal region: case report and review of the literature. J Neurooncol 2006; 78: 153156.
3. Armstrong CL, Gyato K, Awadalla AW et al. A critical review of the clinical effects of therapeutic irradiation damage to the brain: the roots of controversy. Neurophysiol Rev 2004; 14: 6586.
4. Monje ML, Vogel H, Masek M et al. Impaired human hippocampal neurogenesis after treatment for central nevrous system malignancies. Ann Neurol. 2007; 62, 515520.
5. Monje ML, Palmer T. Radiation injury and neurogenesis. Curr Opin Neurol. 2003; 129134.
6. Perry A, Schmidt RE. Cancer therapy associated CNS neuropathology: an update and review of the literature. Acta Neuropathol 2006; 111: 197212.
7. Rola R, Raber J, Rizk A et al. Radiation induced impairment of hippocampal neurogenesis is associated with cognitive deficits in young mice. Exp Neurol 2004; 188: 316330.
8. Vorhees CV, Williams MT. Morris water maze procedures for assessing spatial and related forms of learning and memory. Nat Protoc 2006; 1: 848858.
9. Rowe MK, Chuang DM. Lithium neuroprotection: molecular mechanisms and clinical implications. Expert Rev Mol. Med. 2004;6: 118.
10. Yazlovitskaya EM, Edwards E, Thotala D et al. Lithium treatment prevents neurocognitive deficit resulting from cranial irradiation. Cancer Res 2006; 66: 1117911186.
11. Chen G, Rajokowska G, Du F et al. Enhancement of hippocampal neurogenesis by lithium. J. Neurochem. 2000; 75: 17291734.
12. Yan XB, Hou HL, Wu LM et al. Lithium regulates hippocampal neurogenesis by ERK pathway and facilitates recovery of spatial learning and memory in rats after transient global cerebral ischemia. Neuropharmacology 2007;53: 487495.
13. Moore GJ, Bebchuk JM, WIlds IB et al. Lithium induced increase in human brain grey matter. Lancet 2000; 356:12411242.
14. Foland LC, Altshuler LL, Sugar CA et al. Increased volume of the amygdala and hippocampus in bipolar patients treated with lithium. Neuroreport 2008;19:221224.
15. Dowdan J. Therapeutic Guidelines: Psychotropic. (Version 5). Melbourne: 2003.
16. Foutoulakis KN, Vieta E, SanchezMoreno J et al. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord 2005; 86:110.
17. Berk M, Kapczinski F, Andreazza AC et al. Pathways underlying neuroprogression in bipolar disorder: focus on inflammation, oxidative stress and neurotrophic factors. Neurosci Biobehav Rev 2011; 35:804817.
18. Kessing LV, SOndergard L, Forman JL, Andersen PK. Lithium treatment and risk of dimential. Arch Gen Psychiatry 2008; 65: 13311335.
19. Kessing LV, Forman JL, Andersen PK. Does lithium protect against dementia? Bipolar Disord 2010; 12: 8794.
20. Wingo AP, Wingo TS, Harvey PD, Baldessarini RJ. Effects of lithium on cognitive performance: a metaanalysis. J. Clin Psychiatry 2009; 70: 15881597.
21. Yang ES, Lu B, Hallahan DE. Lithium mediated neuroprotection during cranial irradiation: A phase 1 trial. In ASTRO (American SOciety for Therapeutic Radiology and Oncology) 49th Annual Conference. Los Angeles CA:

2007 \[22\] Xia F, Yang E, Hallahan D, Lu B. Lithium mediated neuroprotection during cranial irradiation: a phase I trial. Neurooncology 2008; 10: 887887.

\[23\] Forlenza OV, Diniz BS, Radanovic M et al. Disease modifying properties of long term lithium treatment for amnestic mild cognitive impairment: randomized controlled trial. The British Journal of Psychiatry: The Journal of Mental Science 2011; 198: 351356.

A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer

Number of participants with adverse events

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

Deakin University

Peter MacCallum Cancer Centre, Australia

Barwon Health

Digestive System Diseases

Stomach Neoplasms

Colorectal Neoplasms

Esophageal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Diseases

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

Capecitabine

Oxaliplatin

Antimetabolites

Target serum concentrations of escalating doses of lithium (0.6, 0.9, 1.26 or 1.4 mmol/L) in combination standard chemotherapy - oxaliplatin and capecitabine.

Dose escalation of Lithium to determine the maximum tolerated dose (MTD)

Dose as used in standard of care - 130 mg/m2.

Dose as used in standard of care - 800 - 1000 mg/m2

Cancer Trials Ireland Dublin 11, Ireland

This study is a phase Ib, open label, multi-centre trial designed to estimate the Maximum Tolerated Dose (MTD) of lithium when combined with a standard chemotherapy regimen of oxaliplatin and capecitabine in patients with advanced, unresectable, oesophago-gastric or colorectal cancer who have received no previous treatment for advanced disease (previous adjuvant or neo-adjuvant treatment is acceptable if completed at least 6 months prior to registration).

The study follows a modified Fibonacci, 3+3, dose escalation design. Patients are enrolled in cohorts of 3. All three patients in each cohort must complete at least two cycles of treatment to be evaluable for toxicity. If a patient cannot complete 2 cycles, another patient will be enrolled.

This study is a Phase Ib, open label, multi-centre, dose escalation trial to assess the dose of lithium that can be safely combined with standard treatment oxaliplatin and capecitabine chemotherapy.

Registered patients will be treated with lithium combined with a standard chemotherapy regimen of oxaliplatin and capecitabine until a maximum of 6 x 21 day cycles (18 weeks), tumour progression, unacceptable toxicity, pregnancy, withdrawal of consent or withdrawal at the discretion of the investigator, whichever occurs first.

After discontinuation of study treatment, all patients will be followed for safety for at least 30 days.

Patients who discontinue treatment for reasons other than disease progression will continue to be followed every 9 weeks in accordance with standard of care for efficacy (i.e. tumour assessment) until disease progression, death, withdrawal of consent, loss to follow up or until the start of a new anti-neoplastic treatment, whichever occurs first.

Once the patient has documented disease progression, they will be followed up every three months (±1 month) for survival status.

The trial will be a traditional 3+3 design: cohorts of 3 patients will be treated with lithium combined with standard treatment oxaliplatin and capecitabine chemotherapy.

The doses of oxaliplatin and capecitabine have been established in prior phase II and III studies and will not be escalated. Lithium target serum concentrations are assigned at registration according to a defined dose escalation scheme. Study lithium dose escalation will follow a modified Fibonacci 3+3 sequence.

A -1 dose level (0.4mmol/L) is included in case dose de-escalation is needed.

The levels of lithium achieved in each patient will be established by regular assessment of steady state serum concentrations.

Lithium will start at a low level and dose escalations will be performed in cohorts of 3 patients according to a standard 3+3 algorithm.

Dose escalation and determination of MTD will be based on the occurrence of Dose Limiting Toxicities (DLT) as defined below.

The first cohort of 3 patients will commence at dose level 1. All patients in each cohort will be observed for two cycles on the specified dose:

* If none of 3 patients at a given dose level experiences a DLT, accrual will continue to the next dose level according to the protocol.
* If 1 of 3 patients experiences a DLT at a given dose level, 3 additional patients will be treated at the same dose. If no additional patient has a DLT in this cohort, accrual will continue to the next dose level according to the protocol.
* If 2 or more patients in 3 or 6 patients treated at a given dose experience a DLT, the next lowest dose level will define the MTD.

A Dose Limiting Toxicity (DLT) is defined as any of the following adverse events occurring during the two first cycles (within 42 days from first dose) of treatment and possibly, probably or definitely related to the combination of lithium, oxaliplatin and capecitabine:

A. Grade 3 or 4 non-haematological toxicity other than nausea, vomiting or fatigue.

B. Grade 3 or 4 thrombocytopenia: grade 4 thrombocytopenia (platelet count \< 25 x 109/L) or grade 3/4 thrombocytopenia (grade 3 platelet count: 25 x 109/L to \< 50 x 109/L) associated with bleeding.

C. Complicated grade 4 neutropenia (\< 0.5 x 109/L): fever, sepsis \> 5 days of duration.

D. Any significant\* grade 2 and higher toxicity other than nausea, vomiting, rash, alopecia or anaemia that persists longer than 35 days after the start of cycle 1.

\*"Significant" defined as affecting quality of life or patient safety as determined by investigator.

Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed every 3 weeks for the 18 weeks. Efficacy assessments (Radiological examination) will be performed on all patients every 9 weeks (+/- 1 week).

An End of Treatment visit will be performed for patients within 30 days (+/- 1 week) post last dose or disease progression.

Lithium: starting dose: 2x 400mg p.o. per day. Initial target blood concentration (Level 1 = 0.6mmol/L).

Oxaliplatin: 130 mg/m2 in 500 ml normal saline (NS) over 120 minutes on Day 1 of each 3 week cycle.

Capecitabine: 1000 mg/m2 b.i.d po on Days 1 to 14 of each 3 week cycle.

Dose Escalation Study of Lithium With Oxaliplatin and Capecitabine in Advanced Oesophago-Gastric or Colorectal Cancer

A Phase Ib, Dose Escalation Study of Lithium When Added to Standard Chemotherapy of Oxaliplatin and Capecitabine in Patients With Advanced Oesophago-Gastric or Colorectal Cancer

The MTD will be based on the incidence of DLT within the two first cycles of lithium in combination with standard chemotherapy of oxaliplatin and capecitabine at each dose level.

PFS will be defined as the time from the start of treatment until disease progression or death as a result of any cause.

ORR is defined as the proportion of patients who receive a Complete Response or a Partial Response (CR + PR).

Safety will be assessed by standard clinical and laboratory tests.

University College Cork

Cancer Trials Ireland

Behaviors and Mental Disorders

Nervous System Diseases

Cognitive Dysfunction

Brain Neoplasms

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

Lithionit 42 mg (lithium sulphate, 6 mmol), start dose 1x1, then slow dose escalation using therapeutic drug monitoring (TDI) to establish a target serum level of 0.5-1.0 mmol/liter.

Identical looking placebo (white round tablet, 10 mm diameter) will be dose escalated and monitored the same way as lithium, with sham values guiding the dosing.

White round tablet, 10 mm. Identical to experimental drug (lithium)

Placebo

Klas Blomgren, MD, Professor

Gustaf Hellspong, MD, PhD Student

Gustaf Hellspong, MD

Klas Blomgren, MD, professor

Randomized, placebo-controlled, double-blinded, parallel group clinical trial to investigate if 6 months of oral lithium tablets (S-lithium 0,5-1,0 mmol/l) will prevent cognitive decline after brain radiotherapy in pediatric brain tumor survivors.

Primary outcome measure is Processing Speed Index (PSI) 2 years after start of study treatment.

Late-appearing cognitive side effects after brain radiotherapy is a potential disabling condition in pediatric brain tumor survivors. It can have profound negative effects on education, career options and quality of life. There is no current interventional drug treatment to prevent this intellectual impairment after brain tumor treatment.

Primary objective:

To assess the efficacy of lithium treatment (up to 7 years) after brain radiotherapy (both whole brain and focal) for central nervous system malignancy in preventing late-appearing cognitive processing speed impairment in children aged 5 or older.

Secondary objectives:

* To assess the efficacy of lithium treatment through evaluation of other neuropsychological/quality of life test scores.
* To assess the efficacy of lithium treatment through evaluation of radiological findings after lithium treatment using Magnetic Resonance Imaging (MRI) of the brain.

Exploratory objectives:

To explore the feasibility, safety and tolerability of lithium treatment in this patient group, using side effect forms/adverse events (AE) reporting and laboratory measures.

Randomization is based on whether or not the study participant had received radiotherapy to the whole brain (CSI) or only part of it (focal irradiation). Within each of these two arms there is a predetermined block randomization with a 2:1 lithium:placebo ratio.

Identical-looking placebo is used. S-lithium levels are masked by using a separate lab service and sham values for placebo group.

Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

* Number of potentially eligible patients identified
* Number of patients screened
* Number of patients randomized
* Number of patients completing the study per protocol
* Number of patients terminating study during IMP treatment period (6 months).
* Number of patients terminating study during follow-up period (up 5 years post IMP treatment)

* Description of reason why eligle patient declined screening
* Description of reason why screened patient was not randomized/included
* Description of reason(s) for early study termination.

Duration of IMP treatment, measured in total number of days where IMP was taken

* Numbers of IMP dose reductions
* Number of IMP temporary stops

* Descriptions of reason(s) for IMP dose reductions
* Descriptions of reason(s) for IMP temporary stops
* Descriptions of reason(s) for IMP premature (before per protocol) permanent stop.

* Number of target serum concentration measurements within target range (0.5-1.0 mmol/liter) divided by total number of measurements.
* Number of target serum concentration measurements above target range (0.5-1.0 mmol/liter) divided by total number of measurments
* Number of target serum concentration measurements below target range (0.5-1.0 mmol/liter) divided by total number of measurments

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Cognitive processing speed. Normed score min 45, max 155. Higher = better.

* Verbal Comprehension Index (VCI)
* Visual Spatial Index (VSI)
* Fluid Reasoning Index (FRI)
* Working Memory Index (WMI)

Normed score min 45, max 155. Higher = better.

Motor speed / manual dexterity. Unit: time in seconds to complete all pegs. Lower=better.

Visual motor integration. Normed score min 1, max 19. Higher = better.

Sustained attention. Multiple T-scores, min 0, max 80. Higher = better.

Executive function and inhibition, age 8 years and above. Normed score min 1, max 19. Higher = better.

Executive function and inhibition. Normed score min 1, max 19. Higher = better.

Executive function and inhibition, age below 8 years. Normed score min 1, max 19. Higher = better.

Health related quality of life. Score min 0, max 100. Higher=better.

Loneliness scale. Score min 3, max 9. Lower = better.

Psychosocial strengths and difficulties. Score min 0, max 40.

Executive function. Score min 20, max 80.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Initial Study of Lithium in Patients With Medullary Thyroid Cancer	NCT00582712	Medullary Thyro...	Lithium carbona...	18 Years -	University of Wisconsin, Madison
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer	NCT02198859	Prostate Cancer	Lithium Carbona...	18 Years -	University of Kansas Medical Center
Lithium for Low-Grade Neuroendocrine Tumors	NCT00501540	Neuroendocrine ...	Lithium Carbona...	18 Years -	University of Wisconsin, Madison
A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer	NCT01486459	Small Cell Lung...	Lithium	18 Years -	Barwon Health
Dose Escalation Study of Lithium With Oxaliplatin and Capecitabine in Advanced Oesophago-Gastric or Colorectal Cancer	NCT03153280	Colorectal Neop... Stomach Neoplas... Esophageal Neop...	Lithium Oxaliplatin Capecitabine	18 Years -	Cancer Trials Ireland
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy	NCT06051240	Cognitive Impai... Cognitive Decli... Radiotherapy Si... Radiotherapy; C... Brain Tumor Memory Impairme... Late Effect of ...	Lithium Placebo	5 Years -	Region Stockholm
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy	NCT06051240	Cognitive Impai... Cognitive Decli... Radiotherapy Si... Radiotherapy; C... Brain Tumor Memory Impairme... Late Effect of ...	Lithium Placebo	5 Years -	Region Stockholm
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy	NCT06051240	Cognitive Impai... Cognitive Decli... Radiotherapy Si... Radiotherapy; C... Brain Tumor Memory Impairme... Late Effect of ...	Lithium Placebo	5 Years -	Region Stockholm
Lithium for Low-Grade Neuroendocrine Tumors	NCT00501540	Neuroendocrine ...	Lithium Carbona...	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for lithium

Every month we try and update this database with for lithium cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lithium

Every month we try and update this database with for lithium cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lithium cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.