Study of ART27.13 for Patients with Cancer-Related Anorexia and Weight Loss

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What is this study about?

This clinical trial is focused on studying a condition known as Cancer Anorexia, which involves a loss of appetite and weight loss in patients with cancer. The trial is testing a new treatment called ART27.13, a synthetic cannabinoid, which is a man-made substance similar to chemicals found in the cannabis plant. The purpose of the study is to explore how effective ART27.13 is in helping patients gain weight, increase lean body mass, and improve their appetite and overall well-being.

Participants in the study will receive ART27.13 in the form of a hard capsule taken by mouth. Some participants may receive a placebo, which looks like the treatment but does not contain the active substance. The study will last for 12 weeks, during which the dose of ART27.13 may be gradually increased every four weeks for some patients. The study aims to observe changes in weight, appetite, and quality of life over this period.

The trial will also monitor the safety of ART27.13 by checking for any side effects and assessing the overall health of participants through regular medical tests and questionnaires. This research is important for understanding how ART27.13 can potentially help people with cancer who are experiencing significant weight loss and appetite issues.

1 enrollment

Upon joining the study, the patient will be required to sign an informed consent document. This document confirms understanding of the study and agreement to participate.

The patient must meet specific criteria, including having cancer with anorexia, documented weight loss, and a life expectancy of at least 12 weeks.

2 initial assessment

Before starting the treatment, the patient will undergo initial assessments to confirm eligibility. These assessments include laboratory tests to check blood counts, kidney, and liver function.

The patient must refrain from driving or operating heavy machinery for the first 4 weeks due to potential side effects such as dizziness.

3 treatment phase 1

The patient will begin treatment with either ART27.13 or a placebo. The medication is administered orally in the form of a hard capsule.

For the first 12 weeks, the patient will receive a stable dose of 650 micrograms of ART27.13 if enrolled before design changes. Otherwise, the dose may be adjusted every 4 weeks based on the patient’s response.

4 monitoring and assessments

Throughout the trial, the patient’s weight, lean body mass, and appetite will be monitored at 4, 8, and 12 weeks using various assessments, including DEXA scans and questionnaires.

The patient’s safety will be evaluated by monitoring for any adverse effects and conducting routine blood tests, urinalyses, and electrocardiograms.

5 treatment phase 2

If the patient continues to meet the criteria, they may proceed to the second phase of treatment, which involves further dose adjustments of ART27.13 or continued placebo administration.

The focus remains on assessing weight gain, lean body mass, and improvement in appetite.

6 completion and follow-up

Upon completion of the 12-week treatment period, the patient will undergo final assessments to evaluate changes in body mass and appetite.

The study aims to conclude by June 2025, with ongoing monitoring of the patient’s quality of life and any long-term effects of the treatment.

Who Can Join the Study?

Have cancer (except those excluded by the exclusion criteria) confirmed by tests called histopathology or cytology.
Understand and voluntarily sign and date an Informed Consent Document (ICD) before any study-related assessments or procedures.
Willing and able to follow the study visit schedule and other study requirements.
Agree not to drive or operate heavy machinery for the first 4 weeks of treatment or longer if side effects require it, as known side effects of ART27.13 include dizziness and sleepiness.
Have anorexia, which means a self-reported decrease or lack of appetite or dislike of food.
Have documented, unintentional weight loss of more than 5% of body weight and a continuous downward trend of weight loss in the past 6 months (plus or minus 2 weeks) from the date of enrollment.
Patients are either: not on any anti-cancer therapy for the 2 weeks before enrollment and not expected to have anti-cancer therapy for the first 12 weeks after the first dose of ART27.13 (Stage 1) or if in Stage 2, after the start of ART27.13/placebo OR on stable dosing from 2 weeks before enrollment and expected to be on such therapy for another 12 weeks of anti-cancer therapies.
Estimated life expectancy of at least 12 weeks as judged by the study doctor based on clinical impression.
Have a KPS (Karnofsky Performance Status) of more than 50, which is a way to measure the ability to perform daily activities.
At least 18 years of age at the time of enrollment.
Have adequate blood, kidney, and liver function based on laboratory values obtained within 14 days of randomization, including:
- Absolute neutrophil count of at least 1.0 × 10⁹/L
- Platelets of at least 75 × 10⁹/L
- Serum creatinine no more than 1.5 times the upper limit of normal
- Total serum bilirubin no more than 1.5 times the upper limit of normal (up to 3.0 times if diagnosed with Gilbert’s syndrome or liver metastases)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (AP) no more than 2.5 times the upper limit of normal (up to 5.0 times if diagnosed with liver metastases)
For women who can have children and for men with partners who can have children, agree to use birth control measures during treatments and for 6 months after the last study treatment.

Who Cannot Join the Study?

Patients who have a different medical condition than the one being studied, which is Cancer Anorexia.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to provide consent to participate in the study.
Patients who have any other medical condition that might interfere with the study or make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or medical procedure that might affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication or similar medications.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country	Status
St. Olavs Hospital HF	Trondheim	Norway
University Hospital Galway	Galway	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Recruiting	02.10.2023
Norway	Recruiting	02.10.2023

Trial locations

Investigated drugs:

ART27.13 is a synthetic cannabinoid being studied for its potential to help patients with cancer who are experiencing anorexia and weight loss. The trial aims to see if ART27.13 can help patients gain weight, increase lean body mass, improve their performance status, and reduce anorexia symptoms over a period of 12 weeks.

Cancer Anorexia – Cancer anorexia is a condition characterized by a significant loss of appetite and reduced food intake in individuals with cancer. This can lead to weight loss, muscle wasting, and a decrease in overall strength and energy levels. The progression of cancer anorexia often involves a complex interaction between the cancer itself, the body’s response to the disease, and the side effects of cancer treatments. As the condition advances, patients may experience a decline in their physical function and quality of life. It is a common issue in cancer patients and can significantly impact their nutritional status and well-being.

Trial ID:

2024-518177-33-00

Protocol code:

ART27.13-100

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of ART27.13 for Patients with Cancer-Related Anorexia and Weight Loss

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?