- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637816
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
Qualitative Study on Experiences Related to Anorexia and the Effects of Anamorelin and Placebo in Advanced Non-Small-Cell Lung Cancer Patients With Anorexia-Cachexia: A Preliminary Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To qualitatively examine experiences related to anorexia in advanced lung cancer patients with anorexia-cachexia and the impact of nine weeks of treatment of oral anamorelin hydrochloride (anamorelin) (100 mg) and placebo.
SECONDARY OBJECTIVES:
I. To explore changes in anorexia-cachexia (measured by the Functional Assessment of Anorexia/Cachexia Treatment [FAACT] anorexia/cachexia subscale [A/CS]) in patients with advanced non-small cell cancer after 9 weeks of oral anamorelin (100 mg) or placebo.
II. To explore changes in anorexia as measured by the 5-item Anorexia Symptom score (derived from the FAACT A/CS) after 9 weeks of oral anamorelin (100 mg) or placebo.
III. To explore any associations between changes in anorexia with body weight, body composition (as assessed by InBody, weight scale, and L3 vertebrae compute tomography [CT] scan), quality of life (Functional Assessment of Cancer Illness Therapy [FACT-G]), Patient Global Impression of Severity (PGIS), Patient Global Impression of Change (PGIC), nutritional markers (pre-albumin, IGF-1 and IGFBP-3), inflammatory biomarkers (C-reactive protein [CRP], monocyte IL-6&R, TNF-a&R, IL-10,IL-8, IL-1&RA), and food intake after 9 weeks of oral anamorelin (100 mg) or placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive anamorelin hydrochloride orally (PO) daily for 9 weeks in the absence of disease progression or unaccepted toxicity.
ARM II: Patients receive placebo PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (anamorelin hydrochloride)
Patients receive anamorelin hydrochloride PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.
|
Ancillary studies
Given PO
Other Names:
|
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.
|
Given PO
Other Names:
Ancillary studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Baseline up to day 64
|
A 60-90 minute interview will be conducted to identify and explore a range of issues, including: impact on daily psycho-social function (relationships, work, mood, initiative, pleasurable activities); food intake; independence; physiological changes in appetite/eating; visuality of cachexia; weight loss interpreted as a "bad sign"; response from health care professionals; conflict over food; coping responses; and the patient's report of meaningful change in symptoms due to the intervention (and if so, why).
|
Baseline up to day 64
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Explore changes in anorexia/cachexia in patients with advanced non-small cell cancer after oral anamorelin 100 mg/placebo treatment
Time Frame: 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.
|
Baseline up to day 64
|
Explore changes in anorexia after 9 weeks of oral Anamorelin 100 mg or placebo treatment
Time Frame: 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".
|
Baseline up to day 64
|
Explore associations between changes in anorexia and body composition assessed with body weight in kilograms and (lean body mass in kilograms).
Time Frame: Baseline up to day 64
|
Body weight and height will be combined to report BMI in kg/m^2
|
Baseline up to day 64
|
Explore associations between changes in anorexia with nutrition assessed by serum pre-albumin, Insulin Growth Factor-1 (IGF-1), and IGF binding protein-3 (IGFBP-3).
Time Frame: Baseline up to day 64
|
Measured by blood proteins to evaluate nutrition improvement related to loss of appetite and body weight loss.
|
Baseline up to day 64
|
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.
Time Frame: Baseline up to day 64
|
Measured by blood proteins (cytokines) to evaluate inflammation improvement related to loss of appetite and body weight loss.
|
Baseline up to day 64
|
Explore associations between changes in anorexia with quality of life assessed by Functional Assessment of Cancer Illness Therapy (FACT-G)
Time Frame: 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".
|
Baseline up to day 64
|
Explore any associations between changes in anorexia assessed by Patient Global Impression of Severity (PGIS) Scale
Time Frame: 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..
|
Baseline up to day 64
|
Explore any associations between changes in anorexia assessed by Patient Global Impression of Change (PGIC)
Time Frame: Baseline up to day 64
|
PGIC is a validated global PGIC 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 using the following questions: "Since the start of the treatment, how would you describe your change in appetite/eating-related symptoms?"
and "Since the start of treatment, how would you describe your change in your overall condition?"
Determined by participant's responses ranging from "Very Much Improved" to "Very Much Worse".
|
Baseline up to day 64
|
Explore any associations between changes in anorexia with food intake after 9 weeks of oral Anamorelin 100 mg or placebo treatment
Time Frame: Baseline up to day 64
|
Participants will record their food and beverage intake at the time of consumption using MyFitnessPal.
|
Baseline up to day 64
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sriram Yennu, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-1059 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01593 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia
-
Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Mental Health Services in the Capital Region, DenmarkForeningen Spiseforstyrrelser og SelvskadeRecruitingFamily Relations | Anorexia in Adolescence | Anorexia in ChildrenDenmark
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
-
Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
-
Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Wageningen UniversityDutch Dairy Organization (NZO)CompletedAnorexia of AgeingNetherlands
-
Badr UniversityRecruitingAnorexia in AdolescenceEgypt
-
Bambino Gesù Hospital and Research InstituteRecruitingAnorexia in AdolescenceItaly
-
Psychiatric University Hospital, ZurichRecruitingAnorexia in AdolescenceSwitzerland
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States