NCT05546476

The PROACC-1 clinical trial is exploring a potential new treatment option for people suffering with cachexia (unexplained weight loss) associated with non-small cell lung cancer (NSCLC), pancreatic cancer (PANC) or colorectal cancer (CRC). Tomorrow's breakthroughs start today with you.

The PROACC-1 clinical trial will help us to learn if an investigational or study drug can treat symptoms related to cachexia in people with NSCLC, PANC or CRC compared to a placebo.

Your doctor may have recommended the PROACC-1 clinical research study, or perhaps you found your way here by yourself; either way, we hope you will consider joining our study.

Card Summary Component

Who may participate

Thank you for your interest in the PROACC-1 clinical research study, where we are looking to recruit 168 participants to join us in this global study.

To participate you will have cachexia associated with NSCLC, PANC or CRC (and no other reason for cachexia). You do not have any other conditions causing decreased food intake, are not receiving tube feeding and have not had major surgery in the previous 4 weeks and are not awaiting surgery.

Condition

Cachexia associated with Non-small cell lung cancer (NSCLC), pancreatic cancer (PANC) or colorectal cancer (CRC)

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18 years of age or older

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

Card Summary Component

What to expect

To see if you may qualify for participation in the PROACC-1 study, you will be asked to attend one or more screening visits, where the study team will determine if this study could be a good fit for you. These visits may involve a physical examination (including weight), electrocardiogram (ECG), computerized tomography (CT) scan, blood and urine tests and completion of some questionnaires about your symptoms and quality of life.

If selected, you will be randomly assigned to receive either the study drug, or a placebo for 12 weeks (Part A). You will not know whether you are given study drug or placebo during this period. A placebo does not contain any active ingredients, but the study drug and the placebo both look alike.

Following this you will be given the opportunity of receiving the study drug every four weeks for a further 52 weeks (Part B).

The study team will then perform some tests and monitor your health, known as the monitoring period, 4 or 8 weeks after your last study dose.

Length of study treatment

About 72 weeks (Part A is 20 weeks and Part B is 52 weeks)

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

About 21 visits (Part A has 8 visits and Part B has 13 visits once every 4 weeks)

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Study detail

What happens at each study visit will vary, some study visits may take longer than others. This is dependent upon the tests and procedures that take place on the day.

After the screening period, you will be randomly assigned to receive either the study drug or a placebo for 12 weeks. A placebo does not contain any active ingredients, but the study drug and the placebo look alike. Following this, all participants will be given the opportunity to receive the study drug for a further 52 weeks (400mg; highest dose level).

This is through a process called randomization, where you will be assigned to a treatment group by chance (like flipping a coin) rather than by choice and is one way to help avoid bias in a study.

You will have a 75% (3 in 4) chance of receiving the study drug and a 25% (1 in 4) chance of receiving the placebo.

About cachexia associated with cancer

About cachexia associated with cancer

NSCLC, PANC and CRC are common types of cancer with a high prevalence of cachexia1. Cachexia is a body wasting condition and is the loss of fat and muscle, due to a chronic disease such as cancer. It causes weight loss, loss of appetite, weakness, and fatigue. It typically affects people with NSCLC, PANC, or CRC (amongst others) and has a significant impact on people’s quality of life and their ability to do basic tasks such as bathing and grooming. Cachexia is also distressing for sufferers and their family due to very visible changes in body image. Good nutrition is important for the healing and recovery from treatment for cancer and therefore treatments are aimed at stimulating appetite, reducing nausea, pain, and constipation2. Although even with these treatments people with cachexia may not gain or even maintain their weight1.

References:

1. NCI. Tackling the conundrum of cachexia in cancer. 2011. Found at: https://www.cancer.gov/about-cancer/treatment/research/cachexia

2. Dhanapal R et al. 2011 ‘Cancer cachexia’ Journal of Oral and Maxillofacial Pathology, vol. 15 no. 3, pp. 257-260

About the study medicine

About the study medicine

The PROACC-1 study will help us learn if an investigational drug can treat symptoms related to cachexia in people with NSCLC, PANC, or CRC compared to a placebo. The study drug is thought to work by blocking the action of a protein that is associated with cachexia in NSCLC, PANC and CRC. It may promote appetite, increase body weight, and improve quality of life of people with cachexia associated with cancer.

Investigational means that the study drug has not yet been approved for use in patients with cachexia associated with NSCLC, PANC, or CRC and placebo is a dummy drug and does not contain an active drug.

Frequently asked questions

How common is Cachexia associated with cancer?

Cachexia is a serious but under-recognized consequence of cancer and is present in 50-80% people with advanced cancer.

Von Haehling S, Anker SD 2014 ‘Prevalence, incidence and clinical impact of cachexia: facts and numbers – update 2014’ J Cachexia Sarcopenia Muscle, vol 5 no. 4, pp. 261-263

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What are the current treatment options for cachexia associated with cancer?

Cachexia is typically treated with a number of different methods because of the various symptoms involved; nutritional supplements, specific diets, modest physical activity and drugs (e.g. appetite stimulators, steroids, anti-inflammatory drugs).

Ahmad SS et al. 2022 ‘Molecular mechanisms and current treatment options for cancer cachexia’ Cancers (Basel), vol 14 no. 9 pp. 2107

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What are the benefits of taking part?

It is possible that your condition or health may improve, worsen, or stay the same, but there is no guarantee you will benefit. Your health will be closely monitored during the study and your participation may help people in the future by increasing our understanding of the investigational/study drug and cachexia associated with cancer.

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Is participation in a clinical research study voluntary?

Yes, participation in any clinical research study is completely voluntary. If you decide to stop taking part at any time, it does not affect the medical care you would otherwise receive.

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What are the chances of receiving the placebo in the first 12 weeks?

You will have a 75% (3 in 4) chance of receiving the study drug and a 25% (1 in 4) chance of receiving the placebo.

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Are there risks in taking part in the study?

Participant safety is the top priority of this clinical trial. Before you participate, you will be provided with an informed consent document that explains the potential risks and benefits in detail. Your health will also be monitored by the study team while in the study.

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What happens to my personal information?

Information about your personal health will be kept private and confidential. If you decide to contact us, your details will be transferred to the PROACC-1 study team. A representative from the study team will contact you to determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the FDA.

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