Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer (NCT03637816) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
United States25 participantsStarted 2018-11-27
Plain-language summary
This phase II/III trial studies how well anamorelin hydrochloride works in reducing anorexia in patients with non-small cell lung cancer that has spread to other places in the body. Anamorelin hydrochloride may help to improve patients' appetite in order to stop weight loss.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a diagnosis of advanced non-small cell lung cancer
* Presence of anorexia, defined as =\< 37 points on FAACT A/CS domain (on a 0 to 48-point scale in which 0 = worst possible anorexia/cachexia)
* 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
* Adequate hepatic function, defined as aspartate transaminase (AST) and alanine transaminase (ALT) levels =\< 5 x upper limit of normal (ULN)
* Life expectancy of \>= 6 months
Exclusion Criteria:
* Major contraindication to anamorelin i.e. hypersensitivity
* BMI \>= 28 kg/m\^2
* Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
* Pregnant or lactating women. Women of childbearing age not on birth control. For inclusion in the study, a negative pregnancy test for women of childbearing potential, as defined by intact uterus and at least one ovary, and a history of menses within the last 12 months is necessary. Pregnancy test is to be performed no greater than 14 days prior to consent in study. In cases of women with elevated b-human chorionic gonadotropin (HCG), these candidates will be eligible to participate so long as th…
What they're measuring
1
To reach thematic saturation by qualitatively examining experiences related to anorexia at the baseline in advanced lung cancer patients with anorexia/cachexia receiving either oral Anamorelin 100 mg or placebo.