Who may participate

Joining a clinical trial is an important and personal decision. Your doctor may have mentioned this study to you, or perhaps you found your way here by yourself. Either way, thank you for your interest.

This study may be a good fit for you if you have advanced cancer and are experiencing loss of appetite that has resulted in unintentional weight loss, weakness, and fatigue.

You may qualify if you have been diagnosed with any of the following:

  • Non–small cell lung cancer
  • Pancreatic cancer
  • Colorectal cancer
  • Prostate cancer
  • Breast cancer
  • Ovarian cancer
Condition
Loss of appetite associated with advanced cancer
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
The age a person must be to participate in a research study.
Sex
All
The sex of people who may participate in a research study. Sex is a person's classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

You will also need to meet a few other requirements in order to participate. Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the study team can determine if you qualify to enroll in the study.

What to expect

This study starts with a screening visit to see if you could be a good fit. Then, if you qualify and choose to take part, you will receive two injections of the study drug or a placebo (but you won't know which) over the course of six weeks. If you decide to continue to the optional open-label treatment period, you will receive injections of the study drug every three weeks for up to 18 weeks. No one will receive the placebo in the open-label treatment period of this study.

After the first two clinic visits, you have the option of having a home healthcare provider call you or come to your home to perform the assessments.

If you’d like, a caregiver can be a part of this study with you. A caregiver is someone who knows you well and provides you with support related to your condition.

Length of study treatment
Up to 24 weeks

Length of study treatment is the length of time the study participants will receive the study treatment. This includes both the 6-week treatment period and an optional open-label treatment period.

Number of study visits
Up to 12 study visits

The design of each research study specifies the number of study visits and the total length of the study.

Long-term follow-up
The study team will check in on you about one month after your last dose

Some studies require the study team to stay in contact with the participant for a period of time after completing participation in the study. This long-term follow-up period is to collect additional information on the study drug over time.

Open-label treatment period
Up to 18 weeks

During this optional period, the study drug will be given to all participants and no one will receive the placebo.

Living with Advanced Cancer and Anorexia

What does taking part involve?

Whether you have study visits at home or at a study clinic, your health will be assessed in several ways. These include:

  • Questions about your appetite, fatigue, and pain levels, and overall health
  • Physical exams
  • Samples of your blood and urine
  • Pregnancy testing (if applicable)

Frequently Asked Questions

What is a research study?

A research study helps scientists learn more about a disease or condition and explores the safety and effectiveness of a potential treatment to better manage it. That's why the volunteers who take part in clinical research are so important. It's because of their generous time and contributions to research that new and better drugs are able to be made.

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What is a study drug?

A drug that is being investigated in a study.

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What is a subcutaneous injection?

A needle inserted under the skin to deliver the study drug. During this study, a healthcare professional will give the injection either at home or at the study clinic.

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What is a placebo?

A substance sometimes used in studies that contains no active ingredients but looks like the study drug. Placebos are used to compare the experiences of the participants who receive the study drug with those who receive the placebo.

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What is a caregiver?

A caregiver is someone who knows you well and provides support related to your condition.

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Will I still see my regular doctor?

This study does not replace regular medical care, so you will still receive the usual support from your primary care doctor.

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Can I leave the study?

Participating in a study is completely your choice. You can choose to take part and then change your mind at any time and for any reason without impacting your regular medical care.

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What happens if my health gets worse?

Your safety is the most important part of this research. Your health will be carefully monitored throughout the study. If it gets worse, your study team will decide if you should stop taking the study drug or if other measures need to be taken.
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