#1 Clinical Trials Search in Europe

Calcium Folinate

Calcium folinate, also known as leucovorin or folinic acid, is being studied in several clinical trials for its potential benefits in treating various medical conditions. These trials aim to evaluate the efficacy and safety of calcium folinate when used alone or in combination with other drugs for conditions such as autism spectrum disorder, colorectal cancer, pancreatic cancer, and hereditary spastic paraplegia. The research focuses on improving patient outcomes, reducing side effects of other medications, and exploring new treatment options.

Table of Contents

What is Calcium Folinate?

Calcium folinate, also known as leucovorin calcium, L-leucovorin, L-folinic acid (calcium salt), or L-folinate (calcium salt), is an important medication used in various medical treatments[1][2]. It is a form of folic acid that can be easily used by the body. Calcium folinate plays a crucial role in many bodily processes, including the production of DNA and red blood cells.

Conditions Treated with Calcium Folinate

Calcium folinate is used to treat or manage several conditions:

  • Autism Spectrum Disorder (ASD): Some clinical trials are investigating the use of calcium folinate to improve language and social communication skills in young children with ASD[1][2].
  • Cancer: It is often used in combination with other drugs to treat various types of cancer, including:
  • Osteosarcoma: It is used in combination with high-dose methotrexate therapy for bone cancer[7].
  • Toxoplasmosis: Calcium folinate is used alongside other medications to treat this parasitic infection[8].

How Calcium Folinate Works

Calcium folinate works in different ways depending on the condition being treated:

  • In cancer treatment, it helps to protect healthy cells from the harmful effects of certain chemotherapy drugs, such as methotrexate[7].
  • For ASD, researchers believe it may help improve brain function and communication skills, though the exact mechanism is still being studied[1][2].
  • In toxoplasmosis treatment, it helps to enhance the effectiveness of other medications used to fight the infection[8].

How Calcium Folinate is Administered

Calcium folinate can be given in several ways:

  • Intravenous (IV) infusion: The medication is delivered directly into the bloodstream through a vein. This is common in cancer treatments[9].
  • Oral medication: It can be taken by mouth in the form of tablets or liquid[9][1].

The dosage and frequency of administration depend on the specific condition being treated and the individual patient’s needs. For example, in some cancer treatments, it might be given every two weeks[4], while in ASD studies, it’s administered daily[1][2].

Combination Therapies

Calcium folinate is often used in combination with other medications to enhance treatment effectiveness:

  • In cancer treatment, it’s frequently combined with drugs like 5-fluorouracil, oxaliplatin, and irinotecan[4][6].
  • For toxoplasmosis, it’s used alongside pyrimethamine[8].
  • In osteosarcoma treatment, it’s used with high-dose methotrexate[7].

Current Clinical Trials

Several ongoing clinical trials are exploring new uses for calcium folinate:

  • Treatment of language and social communication deficits in young children with autism[1][2].
  • Use in combination with new cancer treatments for pancreatic and colorectal cancers[5][6].
  • Treatment of a rare genetic disorder called Spastic Paraplegia 56[9].

Potential Side Effects

While calcium folinate is generally well-tolerated, it may cause some side effects. These can vary depending on the condition being treated and other medications being used. Common side effects may include:

  • Nausea and vomiting
  • Diarrhea
  • Fatigue
  • Changes in blood cell counts

It’s important to note that many clinical trials are still evaluating the safety and efficacy of calcium folinate for various conditions[1][2][9]. Always consult with your healthcare provider about potential side effects and the best treatment options for your specific situation.

Condition Trial Focus Administration Key Outcomes Measured
Autism Spectrum Disorder Improving language and social communication Oral liquid form Language skills, social communication, behavioral symptoms
Hereditary Spastic Paraplegia Treating SPG56 subtype Intravenous and oral Motor function, cognitive function, safety
Colorectal Cancer Adjuvant therapy post-surgery Intravenous with other chemotherapy drugs Disease-free survival, overall survival
Metastatic Pancreatic Cancer Second-line treatment Intravenous with other chemotherapy drugs Progression-free survival, safety, pharmacokinetics
Osteosarcoma Support in high-dose methotrexate therapy Not specified Blood concentration of methotrexate, adverse reactions

FAQ

  • What is calcium folinate and how does it work? Calcium folinate is a form of folic acid that helps in the formation of DNA and RNA. It works by providing the active form of folic acid, which is essential for cell growth and division. In medical treatments, it is often used to enhance the effects of certain chemotherapy drugs or to reduce their side effects.
  • In which medical conditions is calcium folinate being studied? According to the clinical trials data, calcium folinate is being studied in various conditions including autism spectrum disorder, colorectal cancer, pancreatic cancer, hereditary spastic paraplegia, and as a supportive treatment in high-dose methotrexate therapy for osteosarcoma.
  • How is calcium folinate administered in these trials? The administration of calcium folinate varies depending on the study. It can be given intravenously, orally, or as a combination of both. For example, in some trials, it is given as an intravenous infusion, while in others, it is administered orally in liquid form or as tablets.
  • What are some potential benefits of calcium folinate in these trials? Potential benefits being investigated include improved language and social communication in children with autism spectrum disorder, enhanced efficacy of chemotherapy in cancer treatments, reduction of side effects from other medications, and improved motor function in patients with hereditary spastic paraplegia.
  • Are there any side effects associated with calcium folinate use in these trials? While calcium folinate is generally well-tolerated, the trials are monitoring for potential side effects. These may include gastrointestinal symptoms, allergic reactions, or other adverse events. The safety and tolerability of calcium folinate are being carefully evaluated in each study.

Ongoing Clinical Trials on Calcium Folinate

  • Study comparing chemotherapy with or without radiation therapy in patients with resectable gastroesophageal junction cancer using docetaxel, oxaliplatin, fluorouracil and calcium folinate

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Short-Course Radiotherapy and Chemotherapy with Fluorouracil, Irinotecan, and Oxaliplatin for Patients with Locally Advanced Rectal Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Italy

  • Study for Patients with Metastatic Colorectal Cancer with BRAF V600E Mutation Using Encorafenib, Cetuximab, and Chemotherapy Combination

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark Finland Germany +7

  • Study on Irinotecan, Fluorouracil, Oxaliplatin, and Calcium Folinate for Patients with Resectable Stomach and Gastroesophageal Junction Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway Sweden

  • Study of Pembrolizumab with Chemotherapy for Patients with Gastric or Gastroesophageal Junction Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Estonia France Germany Italy Latvia +2

  • Study on Methotrexate and Metformin for Patients with Rheumatoid Arthritis

    Not recruiting

    1 1
    Investigated drugs:
    France

  • Study of Lutetium (177Lu) Edotreotide compared to standard treatment in patients with aggressive Grade 2 and Grade 3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Germany Italy The Netherlands Spain

  • Study on Nipocalimab and Certolizumab for Patients with Active Rheumatoid Arthritis After Advanced Therapy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary Poland

  • Study of Adagrasib and Cetuximab for Patients with Advanced Colorectal Cancer with KRAS G12C Mutation After First-Line Therapy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +9

  • Study on Holmium-166 TARE and Maintenance Therapy with Capecitabine, Bevacizumab, and Drug Combination for Patients with Unresectable Liver-Colorectal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Calcium Folinate: A form of folic acid used in medical treatments to enhance the effects of certain drugs or reduce their side effects. It's also known as leucovorin or folinic acid.
  • Autism Spectrum Disorder (ASD): A developmental disorder characterized by difficulties in social interaction, communication, and restricted or repetitive patterns of behavior or interests.
  • Hereditary Spastic Paraplegia (HSP): A group of inherited disorders characterized by progressive stiffness and contraction of the lower limbs.
  • Metastatic Pancreatic Cancer: A type of cancer that originates in the pancreas and has spread to other parts of the body.
  • Colorectal Cancer: Cancer that starts in the colon or rectum, parts of the large intestine.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients are still alive.
  • Disease Control Rate (DCR): The percentage of patients whose cancer shrinks or remains stable in response to treatment.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. https://clinicaltrials.gov/study/NCT04060017
  2. https://clinicaltrials.gov/study/NCT04060030
  3. https://clinicaltrials.gov/study/NCT00497107
  4. https://clinicaltrials.gov/study/NCT02785146
  5. https://clinicaltrials.gov/study/NCT02697058
  6. https://clinicaltrials.gov/study/NCT06531278
  7. https://clinicaltrials.gov/study/NCT01758666
  8. https://clinicaltrials.gov/study/NCT03258762
  9. https://clinicaltrials.gov/study/NCT06478238