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Dl-Alpha Tocopherol Acetate

This article discusses a clinical trial investigating the use of Dl-Alpha Tocopherol Acetate, also known as Vitamin E, as part of the PENTO protocol for treating Medication-Related Osteonecrosis of the Jaw (MRONJ). The trial aims to assess the effectiveness of this treatment in patients who have developed jaw bone problems due to certain medications. We’ll explore the trial’s objectives, eligibility criteria, and potential benefits for patients suffering from this condition.

Table of Contents

What is DL-ALPHA TOCOPHEROL ACETATE?

DL-ALPHA TOCOPHEROL ACETATE is a form of vitamin E that is being studied as part of a treatment protocol for a specific medical condition. It is also known by several other names, including:[1]

  • all-rac-alfa-Tocopheryl acetate
  • DL-ALPHA-TOCOPHERYL ACETATE
  • DL-ALPHA-TOCOFERIL ACETATE
  • DL-ALPHA-TOCOPHEROL ACETATE
  • ALL-RAC-ALPHA-TOCOPHERYL ACETATE
  • ALL-RAC-ALPHA-TOCOPHEROL ACETATE

This substance is classified as a chemical and is typically administered orally. It belongs to a group of medications known as tocopherols, which are forms of vitamin E.[1]

Medical Condition: Medication-Related Osteonecrosis of the Jaw (MRONJ)

DL-ALPHA TOCOPHEROL ACETATE is being studied as part of a treatment for a condition called Medication-Related Osteonecrosis of the Jaw (MRONJ). This is a serious side effect that can occur in some patients who have taken certain medications, particularly those used to treat bone disorders or cancer.[1]

MRONJ is characterized by exposed bone in the jaw that doesn’t heal properly. It can cause pain, difficulty eating, and other oral health problems. The condition is often associated with medications such as bisphosphonates (used to treat osteoporosis) or certain targeted cancer therapies.[1]

The PENTO Protocol: A Potential Treatment for MRONJ

Researchers are investigating a treatment approach called the PENTO protocol for patients with MRONJ. This protocol includes DL-ALPHA TOCOPHEROL ACETATE (vitamin E) along with other medications. The full name of the protocol is “pentoxifylline, retinol acetate, and DL-alpha tocopherol acetate.”[1]

The study aims to see if this combination of medications can help heal the exposed bone areas in patients with MRONJ. The treatment is given over a 12-month period, and researchers will measure how well it works by looking at the size of the exposed bone area and other factors.[1]

Eligibility Criteria for the PENTO Protocol Study

To participate in this study, patients must meet certain criteria. Some key points include:[1]

  • Being 18 years or older
  • Having a current or past treatment with certain bone medications or cancer therapies
  • Having signs and symptoms of MRONJ for more than 8 weeks
  • Being diagnosed with Stage 2 MRONJ according to specific medical criteria

There are also several conditions that would prevent a person from participating in the study, such as a history of head or neck radiation therapy, recent surgery for MRONJ, pregnancy, or certain medical conditions.[1]

Study Objectives and Endpoints

The main goal of this study is to see how many patients experience healing of their MRONJ after 12 months of treatment with the PENTO protocol. Healing is defined as having an exposed bone area smaller than 5 mm.[1]

Researchers will also look at other factors, including:[1]

  • Changes in pain levels and ability to chew
  • Improvements in nutrition (measured by weight, body mass index, and certain blood tests)
  • How quickly the exposed bone area gets smaller
  • Any side effects of the treatment

Potential Benefits and Risks

While the PENTO protocol, including DL-ALPHA TOCOPHEROL ACETATE, shows promise for treating MRONJ, it’s important to note that this is still an experimental treatment. The study aims to determine how effective and safe it is.[1]

Potential benefits could include healing of the exposed bone, reduced pain, and improved quality of life. However, as with any medical treatment, there may be risks or side effects. The study will carefully monitor patients for any adverse events throughout the 12-month treatment period.[1]

It’s crucial for patients to discuss the potential benefits and risks with their healthcare provider before considering participation in this or any clinical trial.

Aspect Details
Trial Name The PENTO protocol in Medication-Related Osteonecrosis of the Jaw (MRONJ)
Primary Objective Assess healing (bone exposure area < 5 mm) in patients receiving PENTO for osteochimionecrosis at 12 months
Key Inclusion Criteria Age ≥ 18, current/past treatment with bisphosphonates or targeted therapies, AAOMS Stage 2 MRONJ
Key Exclusion Criteria History of head/neck radiotherapy, recent MRONJ surgery, pregnancy, severe medical conditions
Primary Endpoint Percentage of patients with bone exposure area < 5 mm at 12 months
Secondary Endpoints Changes in SOMA score, nutritional parameters, bone exposure area, and treatment tolerance
Drug Information Dl-Alpha Tocopherol Acetate (Vitamin E), part of PENTO protocol, maximum daily dose 1000 mg
Treatment Duration 12 months

FAQ

  • What is Medication-Related Osteonecrosis of the Jaw (MRONJ)? MRONJ is a condition where the jaw bone becomes exposed and damaged due to certain medications, particularly those used to treat bone disorders or cancer. It can cause pain, difficulty chewing, and other oral health problems.
  • What is the PENTO protocol? The PENTO protocol is a treatment regimen being studied for MRONJ. It includes Pentoxifylline, Retinol Acetate (Vitamin A), and Dl-Alpha Tocopherol Acetate (Vitamin E). This trial aims to assess its effectiveness in healing jaw bone exposure.
  • Who is eligible for this clinical trial? Eligible participants are adults (18 or older) with AAOMS Stage 2 MRONJ who have been treated with bisphosphonates or targeted therapies. They must have had symptoms for more than 8 weeks and not have had recent surgery for MRONJ.
  • What is the main goal of this clinical trial? The primary objective is to determine the proportion of patients whose jaw bone exposure area becomes less than 5 mm after 12 months of treatment with the PENTO protocol.
  • How long does the trial last, and what will be monitored? The trial lasts 12 months. Researchers will monitor changes in bone exposure, pain, chewing ability, nutritional parameters, and any side effects of the treatment throughout the study period.

Ongoing Clinical Trials on Dl-Alpha Tocopherol Acetate

  • Study on the Effects of Pentoxifylline, Retinol Acetate, and DL-Alpha Tocopherol Acetate for Patients with Medication-Related Osteonecrosis of the Jaw

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Medication-Related Osteonecrosis of the Jaw (MRONJ): A condition where the jaw bone becomes exposed and damaged due to certain medications, particularly those used to treat bone disorders or cancer.
  • PENTO protocol: A treatment regimen being studied for MRONJ that includes Pentoxifylline, Retinol Acetate (Vitamin A), and Dl-Alpha Tocopherol Acetate (Vitamin E).
  • Dl-Alpha Tocopherol Acetate: A form of Vitamin E used in the PENTO protocol. It's an antioxidant that may help in tissue healing and repair.
  • Bisphosphonates: A class of drugs used to treat bone disorders, such as osteoporosis or bone metastases in cancer patients.
  • Exposure Bone Area (EBA): The area of exposed jaw bone in MRONJ patients, measured to assess the severity of the condition and treatment effectiveness.
  • SOMA score: A modified scoring system used to evaluate various aspects of MRONJ, including pain, chewing ability, bone exposure size, and radiological appearance.
  • Albuminemia: The presence of albumin (a protein) in the blood, used as a marker of nutritional status and overall health.
  • Pre-albuminemia: The presence of pre-albumin in the blood, another protein used to assess nutritional status.
  • Body Mass Index (BMI): A measure of body fat based on height and weight, used to assess nutritional status.
  • Trismus: A condition where a person has difficulty opening their mouth, often associated with jaw problems.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-pentoxifylline-retinol-acetate-and-dl-alpha-tocopherol-acetate-for-patients-with-medication-related-osteonecrosis-of-the-jaw/