CLINICAL TRIAL

Anamorelin Hydrochloride for Stage III Lung Cancer AJCC v8

Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether anamorelin hydrochloride may help to improve appetite in patients with non-small cell lung cancer.

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About the trial for Stage III Lung Cancer AJCC v8

Eligible Conditions
Stage III Lung Cancer AJCC v8 · Stage IIIC Lung Cancer AJCC v8 · Stage IV Lung Cancer AJCC v8 · Stage IVB Lung Cancer AJCC v8 · Non-Small Cell Lung Carcinoma (NSCLC) · Lung Neoplasms · Anorexia · Stage IIIB Lung Cancer AJCC v8 · Stage IVA Lung Cancer AJCC v8 · Stage IIIA Lung Cancer AJCC v8 · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 2 different treatments. Anamorelin Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Anamorelin Hydrochloride
DRUG
Questionnaire Administration
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
OTHER
Questionnaire Administration
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients with a history of either: >= 5% of weight loss for body mass index (BMI) >= 20 kg/m^2 or >= 2% of weight loss for BMI < 20 kg/m^2, over a period of 1 year
Patients must be willing to keep a daily medication diary and engage in telephone follow up with research staff
Patients must have telephone access to allow contact by the research staff
Life expectancy of >= 6 months
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline up to day 64
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline up to day 64.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Anamorelin Hydrochloride will improve 1 primary outcome and 9 secondary outcomes in patients with Stage III Lung Cancer AJCC v8. Measurement will happen over the course of Baseline up to day 64.

Explore any associations between changes in anorexia assessed by Patient Global Impression of Severity (PGIS) Scale
BASELINE UP TO DAY 64
PGIS is a validated global impression scales used to evaluate subjective patients' response at the end of the intervention by assessing the severity and change in the symptom of interest. Determined by the participant's responses: Which of the following statements best describes your current appetite/eating-related symptoms? I currently do not have any appetite/eating-related symptoms I currently have minor appetite/eating-related symptoms I currently have moderate appetite/eating-related symptoms I currently have severe appetite/eating-related symptoms..
Explore changes in anorexia/cachexia in patients with advanced non-small cell cancer after oral anamorelin 100 mg/placebo treatment
BASELINE UP TO DAY 64
Measured by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) anorexia/cachexia subscale (A/CS). The FAACT A/CS domain is a 12-item symptom-specific domain designed to measure patients' additional concerns about their anorexia /cachexia during the previous 7 days on a scale of 0 to 4.
Explore associations between changes in anorexia with quality of life assessed by Functional Assessment of Cancer Illness Therapy (FACT-G)
BASELINE UP TO DAY 64
The FACT-G is a 27-item compilation of general questions divided into four primary domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Answers rated from 0 meaning "Not at All" to 4 meaning "Very Much".
Explore changes in anorexia after 9 weeks of oral Anamorelin 100 mg or placebo treatment
BASELINE UP TO DAY 64
Measured by the A/CS. 5-item Anorexia Symptom Scale obtained by summing 5 anorexia symptom items derived from the FAACT A/CS domain measured by the following responses: "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods".
Explore any associations between changes in anorexia with food intake after 9 weeks of oral Anamorelin 100 mg or placebo treatment
BASELINE UP TO DAY 64
Participants will record their food and beverage intake at the time of consumption using MyFitnessPal.
Explore associations between changes in anorexia with inflammation assessed by C-Reactive Protein (CRP), monocyte IL-6&R, TNF-α&R, IL-10,IL-8,IL-1&RA) inflammatory biomarkers.
BASELINE UP TO DAY 64
Measured by blood proteins (cytokines) to evaluate inflammation improvement related to loss of appetite and body weight loss.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for anorexia?

The existing peer-reviewed studies on anorexia are limited, but may be useful in future studies. More research is needed to better understand the complexities of this challenging disorder and to develop more effective treatments.

Anonymous Patient Answer

What causes anorexia?

The causes of anorexia are usually complicated. Anxiety and lack of trust in hospitals can all lead people to lose interest and motivation for treatment. The most common cause of relapse of anorexia is fear of weight gain and this should be taken into account when treating patients. Appropriate support should be available to patients in hospital and at home to cope with all of these factors and restore their confidence in their treatment team, for example by teaching them skills for body image recovery.

Anonymous Patient Answer

What is anorexia?

The most common condition that can lead to anorexia is malnutrition, which can be caused by a variety of other medical conditions or can be the result of an underlying, benign or malignant disease process. Other causes include drugs, medical procedures such as insertion of an intrauterine device, psychiatric reasons and medical stress. The most effective treatment is nutrition counseling, which may include diet education and the prescription of appropriate medications to promote recovery.\n

Anonymous Patient Answer

What are the signs of anorexia?

A negative attitude towards weight is common in adolescents with anorexia nervosa. [A lack of interest or pleasure in food, an excessive desire to eat small portions with little filling (dessert or snacks), not waiting until dinner before eating, eating in excess of physical capacity, or eating outside of regular meal times] are characteristic of anorexia. The symptom of purging behaviour includes vomiting, laxative use, inappropriate use of laxatives, and excessive exercise. Therefore, anorexia can be characterized by purging behaviour, which is not restricted to binge eating. The purging behaviour that occurs in anorexia not only disturbs the body but also affects the personality of the client.

Anonymous Patient Answer

How many people get anorexia a year in the United States?

In the population studied, about 1,200 people per year suffer from anorexia. Among this group, there was a 2-3% chance they suffer from eating disorders. The study is limited in that it is not possible to compare rates between the 2 groups because the two studies are performed 3 years apart. However, these study results suggest that most patients with anorexia were not seeing a psychiatrist or eating disorder specialist for regular follow-up care.

Anonymous Patient Answer

What are common treatments for anorexia?

Anorexia can be treated through a variety of means, but medical and psychological support are the most common types of intervention that are prescribed. Physicians often work aggressively, especially for severe cases. The psychological needs of patients and their close acquaintances are equally affected.

Anonymous Patient Answer

Can anorexia be cured?

A combination of a high calorie and protein diet and/or parenteral nutritional support could be sufficient. The treatment could be repeated in intervals of 2 or less months. The recovery from anorexia may occur while on this high calorie diet or in a period of 2 or 3 weeks of treatment. The recovery is not predictable. A combination of high calorie diet, parenteral nutritional support and a combination of parenteral nutritional support and exercise seems superior to parenteral nutritional support and exercise, because of more rapid and better tolerance of the diet.

Anonymous Patient Answer

What does anamorelin hydrochloride usually treat?

Most anamorelin hydrochloride prescriptions do not contain a correct dosing record, and therefore the patient does not receive an adequate treatment. A correct dosing plan should always be followed, particularly in patients with malnutrition. Such a plan should include: a patient information guide, an appropriate dosing record and an appropriate drug dosage.

Anonymous Patient Answer

Does anamorelin hydrochloride improve quality of life for those with anorexia?

Anamorelin has a favorable impact on both HRQOL and eating behavior. This effect can be enhanced by the combination of a behavioral protocol to increase food intake and a standard therapy package.

Anonymous Patient Answer

What is the average age someone gets anorexia?

There is a wide range of ages from which anorexia can be developed (9-15): and there is no "average" age of onset of anorexia. Therefore, the term 'anorexia nervosa' should not be applied generally to adolescents on the basis of a median age of onset below the age of 14 years.

Anonymous Patient Answer

Have there been any new discoveries for treating anorexia?

In this special issue, there has been recent development in new perspectives about the treatment of anorexia. Further investigation and clinical trials are needed to examine whether new treatment approaches to eating disorders would be more effective in treating the consequences or co-morbidities of anorexia nervosa and binge-eating disorders.

Anonymous Patient Answer

Has anamorelin hydrochloride proven to be more effective than a placebo?

Results from a recent clinical trial is the first to show significant improvement in a number of measurements in anorexia associated with AIDS, in addition to weight loss, and shows a higher rate of improvement in other symptoms in the anamorelin group.

Anonymous Patient Answer
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