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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Uytyfiawwi Myzoeie Ceqqym Hrmslbjbrfbagblio	Hamburg	Germany
Sdy Fqejyllzpc Hyqwccsq Fmqgsyxzr	Flensburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.03.2024

Trial locations

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.

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 ID:

2024-518917-24-00

Protocol code:

BELCANTO

NCT ID:

NCT06097533

Trial Phase:

Therapeutic exploratory (Phase II)

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

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