NCT06051240RecruitingPhase 2
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Source: ClinicalTrials.gov · Last updated 12 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 12 Jun 2023
- Start date
- 16 Feb 2024
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- Region Stockholm
- Diseases
- Childhood cancers
- NCT number
- NCT06051240
- EU CT number
- 2023-504071-24-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- From 16 Feb 2024 to the primary completion date, 31 Aug 2030
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy/hypersensitivity to lithium or any of the excipients
- Renal failure (Cystatin C derived Glomerular Filtration Rate \< 60).
- Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).
- Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, inability to swallow tablets, language difficulties).
Other
- Uncontrolled hypothyroidism.
- Pregnancy or breast feeding.
- Severe fluid or electrolyte imbalance.
- Karnofsky-Lansky score \< 60.
- Inclusion in other study protocol precluding inclusion in this study.
Who the study is looking for
- Age \>5 years.
- Age \<18 years at time of radiotherapy.
- Has received cranial/craniospinal radiation treatment of brain tumor within the last 7 years.
- Adequate contraceptive method to prevent pregnancy\* during the entire lithium treatment period and six months thereafter.
- Negative pregnancy test\* at screening, at start of study treatment, and monthly thereafter.
- Written informed consent from patient and/or caregiver.
Age in the registry: 5 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Region Oestergoetland Coordinator of this site? Confirm its status | Linkoping | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| University Hospital Of Northern Sweden Coordinator of this site? Confirm its status | Umeaa | Sweden | Recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.