Could a pill help cancer patients eat again?
NCT ID NCT03637816
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether anamorelin, a drug that stimulates appetite, can help advanced lung cancer patients who have lost their appetite and weight. Researchers will interview 25 patients and compare those taking the drug to those taking a placebo. The goal is to see if the drug improves quality of life and reduces the effects of cachexia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anamorelin hydrochloride
- What this could lead to
- If it works, this could point toward a treatment that helps cancer patients regain appetite and stop weight loss.
- What could go wrong
- This is a small, early-phase study with only 25 participants, so results may not apply to everyone. The drug may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
25 people
The number who actually took part.
- Started
-
Nov 2018
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 the level of b-HCG is not consistent with pregnancy. Women of childbearing potential must be on or use contraception during the study period. Their male partners must also use contraception (condom) or maintain abstinence. Birth control specifications: Women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose. Acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide * Uncontrolled diabetes mellitus (fasting blood sugar \> 200 mg/dl) at screening * Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin) * Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine) * Patients currently on investigational therapies will be evaluated by the principal investigator (PI) on a case by case basis and study participation approval will be obtained from the treating oncologist * Patient currently taking androgenic compounds (including but not limited to testosterone, testosterone-like agents, oxandrolone, megestrol acetate, methylphenidate, corticosteroids \[note: topical, inhaled, or oral corticosteroids taken for a short duration (=\< 5 consecutive days) after chemotherapy are acceptable\]), dronabinol or medical marijuana (medical cannabis) or any other prescription medication or off-label products intended to increase appetite or treat unintentional weight loss * Any relevant condition that would interfere with ability to participate in one-on-one interviews either in person or via telephone
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anorexia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can we predict and treat cancer wasting better? a new study investigates
- Facing the fear: a new program aims to ease anxiety in advanced cancer
- Can a Chemo-Immunotherapy duo outsmart tough lung cancer?
- Could a simple assessment help older lung cancer patients tolerate chemo better?
- Could a muscle relaxant help fight lung cancer? scientists test papaverine with standard therapy
- Crunch test: could hearing loss steal the joy of a crispy biscuit?