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Study on Improving Quality of Life in Cancer Patients Using Dronabinol and Cannabidiol

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on improving the quality of life for patients with cancer who are receiving palliative care. The study will use a treatment called Cannabis Extract Avextra 10/10 Solution, which contains two active substances: dronabinol (also known as THC) and cannabidiol (also known as CBD). These substances are derived from cannabis and are being tested to see if they can help reduce the overall burden of symptoms experienced by cancer patients.

The purpose of the study is to gather evidence on whether this cannabis extract can improve symptoms compared to a placebo. Participants in the study will take the treatment orally for a period of up to eight weeks. During this time, their symptoms will be monitored and compared to those of a group receiving a placebo. The study aims to assess changes in symptoms such as pain, sleep quality, and overall distress, using tools like the Edmonton Symptom Assessment System and other quality-of-life questionnaires.

The results of this trial will help determine the effectiveness of the Cannabis Extract Avextra 10/10 Solution in managing symptoms for cancer patients in palliative care. This information could be used to plan future studies and potentially improve treatment options for patients experiencing significant symptom burdens due to cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, current therapy, and health status.

    Informed consent is required, and if applicable, a negative pregnancy test and safe contraception are necessary.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to measure symptoms using the Edmonton Symptom Assessment System (ESAS).

    This assessment helps establish a baseline for symptom distress.

  3. Step 3

    Medication administration

    The medication used in the trial is the Cannabis Extract Avextra 10/10 Solution, administered orally.

    The dosage and frequency are determined by the study protocol and are aimed at improving quality of life.

  4. Step 4

    Symptom monitoring

    Symptoms are monitored regularly using the ESAS to track changes in symptom distress.

    Additional assessments may include pain scales, quality of sleep, and other quality of life measures.

  5. Step 5

    Comparison and evaluation

    After approximately 12 days, a comparison of symptom changes is made between the intervention group and a placebo group.

    The primary focus is on the change in the ESAS total symptom distress score.

  6. Step 6

    Secondary assessments

    Secondary assessments may include changes in opioid dosage, other pain medications, and overall quality of life.

    Adverse events are monitored and evaluated for frequency and severity.

  7. Step 7

    End of trial participation

    The trial concludes with a final assessment of symptoms and quality of life.

    Results contribute to understanding the effectiveness of the medication in improving quality of life for oncologic patients.

Who can join the trial?

8 criteria

  • Must be **25 years or older** and legally able to make decisions.
  • Currently receiving **palliative-oncological therapy**, which is treatment aimed at relieving symptoms and improving quality of life for cancer patients.
  • Have an **ECOG status** of 1, 2, or 3, which means the person is unable to work due to their condition. ECOG is a scale used to assess how a disease affects a patient's daily living abilities.
  • Have a **Nutritional Risk Screening** score of 3 or higher, indicating a risk of malnutrition.
  • Experience pain with a **numerical rating scale** of 4 or higher, which means the pain is moderate to severe. This scale is a way to measure pain intensity.
  • Must provide **informed consent**, meaning they understand the study and agree to participate.
  • If a **woman of childbearing potential**, must have a negative pregnancy test and use safe contraception with a **Pearl Index** of less than 1%. The Pearl Index measures the effectiveness of birth control methods.
  • Have an **ESAS TSDS** score of 16 or higher for items 1-8. This score is part of a system used to assess the severity of symptoms in patients.

Who cannot join the trial?

3 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are considered part of a vulnerable population.
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Investigated drugs

Cannabisextract Avextra 10/10 solution is being studied for its potential to improve the quality of life in cancer patients. This medication is a cannabis extract that may help reduce the overall burden of symptoms experienced by patients undergoing cancer treatment. The trial aims to determine if this solution can effectively alleviate symptoms such as pain, nausea, and anxiety, which are common in oncologic patients. The goal is to provide evidence for its use in palliative care, potentially leading to better management of symptoms and improved patient comfort.

What is already known about the treatment

Cannabisextract Avextra 10/10 solution – This medication is administered orally in the form of a solution. It is currently being studied in clinical trials to assess its effectiveness in improving the quality of life for patients undergoing palliative care in oncology. The main therapeutic indication is to alleviate the global symptom burden in cancer patients. At the molecular level, cannabinoids interact with the endocannabinoid system, which may help modulate pain, nausea, and other symptoms associated with cancer and its treatment. It is classified pharmacologically as a cannabinoid.

Investigated diseases

  • Oncology

    Oncology is the study and treatment of tumors and cancer. It involves the abnormal growth of cells that can invade or spread to other parts of the body. Cancer can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer can vary widely depending on the type and location of the cancer, as well as the individual characteristics of the patient. Tumors can be benign, meaning they do not spread, or malignant, meaning they can invade nearby tissues and spread to other parts of the body. The growth and spread of cancer can lead to various symptoms and complications, affecting the quality of life.

  • Palliative Care

    Palliative care is a specialized medical care approach focused on providing relief from the symptoms and stress of serious illness. It aims to improve the quality of life for both the patient and their family. This type of care is appropriate at any stage of a serious illness and can be provided alongside curative treatment. Palliative care addresses physical symptoms such as pain, fatigue, and nausea, as well as emotional, social, and spiritual issues. The progression of care is tailored to the individual needs of the patient, with a focus on comfort and support. It involves a team of healthcare providers working together to offer comprehensive support.

  • Quality of Life

    Quality of life refers to the general well-being of individuals and societies, encompassing both physical and psychological aspects. In the context of healthcare, it involves the patient's overall enjoyment of life, including their ability to perform everyday activities and their emotional well-being. Factors affecting quality of life can include pain, fatigue, emotional distress, and social isolation. The progression of quality of life can be influenced by the course of a disease, treatment side effects, and the support systems available to the patient. Improving quality of life is a key goal in managing chronic and serious illnesses, focusing on enhancing comfort and satisfaction.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518917-24-00Protocol codeBELCANTOEstimated enrolment170 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).