#1 Clinical Trials Search in Europe

Folinic Acid

Folinic acid, also known as leucovorin or calcium folinate, is being studied in clinical trials for its potential therapeutic effects in several medical conditions. These trials aim to evaluate the safety and efficacy of folinic acid in treating or managing symptoms associated with autism spectrum disorders, cancer-related side effects, and certain neurological disorders. The research explores different dosages, administration methods, and combinations with other treatments to determine optimal use of folinic acid across various patient populations.

Table of Contents

What is Folinic Acid?

Folinic acid, also known as leucovorin calcium or levoleucovorin, is a form of folic acid, which is an essential B vitamin[1]. It is a reduced form of folate that can be easily used by the body. Folinic acid is important for various bodily functions, including DNA synthesis and repair, which are crucial for normal cell growth and development[1].

Medical Uses of Folinic Acid

Folinic acid has several medical applications and is being studied for its potential benefits in various conditions:

  • Autism Spectrum Disorder (ASD): Research is ongoing to evaluate the effectiveness of folinic acid in improving symptoms of ASD, particularly language and communication skills[1][2].
  • Cancer Treatment: Folinic acid is used in combination with other chemotherapy drugs to treat certain types of cancer, such as colorectal cancer and non-small cell lung cancer[3][4].
  • Reducing Chemotherapy Side Effects: It may help reduce the toxic effects of certain chemotherapy drugs[4][5].

Folinic Acid in Autism Spectrum Disorder

Several studies are investigating the potential benefits of folinic acid for children with Autism Spectrum Disorder:

  • Improvement in language skills: Some research suggests that folinic acid may help improve both receptive (understanding) and expressive (speaking) language in children with ASD[1].
  • Social skills and behavior: Studies are looking at whether folinic acid can help improve social interaction and reduce stereotypical behaviors associated with ASD[1][2].
  • Adaptive skills: Researchers are examining if folinic acid can enhance adaptive skills, which are everyday living skills that help individuals function independently[6].

It’s important to note that while these studies show promise, more research is needed to fully understand the effects of folinic acid in ASD.

Folinic Acid in Cancer Treatment

Folinic acid plays a significant role in certain cancer treatments:

  • Colorectal Cancer: It is often used in combination with other chemotherapy drugs, such as fluorouracil (5-FU), to enhance the effectiveness of treatment[3].
  • Non-Small Cell Lung Cancer: Folinic acid is being studied for its potential to reduce side effects of chemotherapy drugs like pemetrexed[4].
  • Reducing Mucositis: Some studies are investigating whether folinic acid can help prevent or reduce mucositis, a painful inflammation of the mucous membranes that can occur as a side effect of certain cancer treatments[5].

Dosage and Administration

The dosage and administration of folinic acid can vary depending on the condition being treated and the individual patient. Here are some examples from clinical trials:

  • For ASD: Doses ranging from 2mg/kg per day (maximum 50 mg per day) to 5mg twice a day have been studied[6][2].
  • For cancer treatment: Dosages can vary widely and are often based on body surface area. For example, one study used 5 mg/m² given intravenously[5].

It’s crucial to note that folinic acid should only be taken under the supervision of a healthcare provider, who will determine the appropriate dosage based on the specific condition and individual factors.

Potential Benefits

Research suggests that folinic acid may offer several potential benefits:

  • Improved language and communication skills in children with ASD[1].
  • Enhanced effectiveness of certain chemotherapy treatments[3].
  • Reduced side effects from some cancer treatments[4].
  • Possible improvements in social skills and reduction in stereotypical behaviors in ASD[1].

Ongoing Research

Numerous clinical trials are currently underway to further investigate the potential uses and benefits of folinic acid:

  • Studies on its role in improving symptoms of Autism Spectrum Disorder[1][2].
  • Research on its effectiveness in reducing chemotherapy-related side effects[4][5].
  • Investigations into its potential to enhance the efficacy of cancer treatments[3].

As research continues, our understanding of folinic acid and its potential medical applications may expand, potentially leading to new treatments and improved patient outcomes.

Aspect Details
Main Conditions Studied Autism Spectrum Disorders, Cancer-related side effects, Hereditary Spastic Paraplegia
Dosage Range Typically 1-2 mg/kg/day, up to 50 mg/day maximum in some trials
Administration Methods Oral (pills or liquid), Intravenous infusion
Duration of Treatment Varies from 12 weeks to several years, depending on the study
Primary Outcome Measures Language improvement, Reduction of mucositis, Motor function improvement
Secondary Outcome Measures Social skills, Stereotyped behaviors, Cognitive function, Laboratory indicators
Safety Monitoring Blood tests, Adverse event reporting, Regular clinical evaluations
Potential Mechanisms Improving folate metabolism, Reducing oxidative stress, Enhancing cellular function

FAQ

  • What is folinic acid and how does it differ from folic acid? Folinic acid is a form of folate, a B vitamin essential for many bodily functions. Unlike folic acid, which needs to be converted by the body, folinic acid is a reduced form that can be more readily used by cells. This makes it potentially more effective in certain medical conditions where folate metabolism may be impaired.
  • What conditions are being studied with folinic acid in clinical trials? Clinical trials are investigating folinic acid for various conditions, including autism spectrum disorders, cancer-related side effects (such as mucositis from chemotherapy), hereditary spastic paraplegia, and as a protective agent against certain drug toxicities. Some studies also look at its potential in improving language and social skills in children with autism.
  • How is folinic acid administered in these trials? The administration of folinic acid varies across trials. It may be given orally in pill or liquid form, or intravenously. Dosages are often based on body weight and can range from a few milligrams to 50 mg per day, sometimes divided into multiple doses. The duration of treatment also varies, typically lasting several weeks to months.
  • Are there any known side effects of folinic acid? While folinic acid is generally considered safe, clinical trials monitor for potential side effects. Common mild side effects may include nausea, diarrhea, or allergic reactions. More serious side effects are rare but can occur. It's important to note that side effects can vary depending on the dosage and individual patient factors.
  • How do researchers measure the effectiveness of folinic acid in these trials? Researchers use various methods to measure effectiveness, depending on the condition being studied. For autism, they may use standardized scales to assess language skills, social behavior, and overall functioning. In cancer-related studies, they might measure the reduction of side effects like mucositis. Blood tests, imaging studies, and cognitive assessments are also commonly used to track changes and improvements.

Ongoing Clinical Trials on Folinic Acid

  • Study on Induction Chemotherapy with Irinotecan, Folinic Acid, Fluorouracil, and Oxaliplatin for Patients with High-Risk Locally Advanced Rectal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Encorafenib, Cetuximab, and FOLFIRI for Patients with BRAF V600E Mutated Metastatic Colorectal Cancer After Progression on Encorafenib and Cetuximab

    Not recruiting

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

  • Study of Zolbetuximab Alone and with Drug Combination for Patients with Advanced Stomach or Gastroesophageal Junction Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy

  • Study of Durvalumab with Chemotherapy and Radiotherapy for Patients with Unresectable Esophageal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    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 of Oxaliplatin and Nivolumab for Patients with Metastatic Colorectal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • Study on the Safety and Effectiveness of Magrolimab with Bevacizumab and Drug Combination for Patients with Advanced Metastatic Colorectal Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Germany Italy Spain

  • Study of Pembrolizumab in Patients with Esophageal Cancer Undergoing Chemoradiotherapy

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Czechia Denmark Estonia France Germany +4

  • Study on the Effectiveness of Ompenaclid with FOLFIRI and Bevacizumab for Patients with Advanced or Metastatic Colorectal Cancer

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

Glossary

  • Folinic acid: A form of folate (vitamin B9) that can be readily used by cells without needing to be converted by the body. It's also known as leucovorin or calcium folinate.
  • Autism Spectrum Disorder (ASD): A developmental disorder characterized by challenges with social skills, repetitive behaviors, speech, and nonverbal communication.
  • Mucositis: Painful inflammation and ulceration of the mucous membranes lining the digestive tract, often a side effect of certain cancer treatments.
  • Folate Receptor α (FRα): A protein involved in transporting folate into cells, which can be affected by autoantibodies in some conditions.
  • Redox status: The balance between oxidation and reduction reactions in the body, which can affect cellular health and function.
  • Glutathione: An important antioxidant in the body that helps protect cells from damage and is involved in various metabolic processes.
  • Hereditary Spastic Paraplegia: A group of inherited disorders characterized by progressive stiffness and contraction of the lower limbs.
  • CELF: Clinical Evaluation of Language Fundamentals, a standardized test used to assess language skills in children and adults.
  • Vineland Adaptive Behavior Scales: A measure of adaptive behavior, including communication, daily living skills, socialization, and motor skills.
  • Pemetrexed: A chemotherapy drug used to treat certain types of lung cancer and mesothelioma.

References

  1. https://clinicaltrials.gov/study/NCT01602016
  2. https://clinicaltrials.gov/study/NCT02551380
  3. https://clinicaltrials.gov/study/NCT00905047
  4. https://clinicaltrials.gov/study/NCT06010277
  5. https://clinicaltrials.gov/study/NCT01789723
  6. https://clinicaltrials.gov/study/NCT05013164