Symptoms and General Pathology

All Conditions

Recurrence

Fatigue

Body Weight

Weight Loss

Body Weight Changes

Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.

Anamorelin Hydrochloride

Exercise Intervention

Laboratory Biomarker Analysis

Nutritional Assessment

Quality-of-Life Assessment

Questionnaire Administration

Sriram Yennu

This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.

PRIMARY OBJECTIVES:

I. To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized physical activity and nutritional counseling.

SECONDARY OBJECTIVES:

I. To examine the effects of anamorelin and standardized physical activity and nutritional counseling on health-related quality of life and patient reported outcomes as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS), Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G) and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these patients.

II. To examine the side effects and tolerability of anamorelin in these patients.

EXPLORATORY OBJECTIVES:

I. To explore the effects of anamorelin and standardized physical activity and nutritional counseling on muscle function (as measured by the 30 second chair stand test, 6 minute walk test, day time activity \[accelerometer\], body composition \[as measured by INBODY\], and resting energy expenditure \[measured by indirect calorimetry\]).

II. To characterize the effects of anamorelin on potential inflammatory biomarkers of cancer-related fatigue (CRF) (C-Reactive Protein \[CRP\], monocyte IL-6\&R, TNF-a\&R, IL-10, IL-8, IL-1\&RA; IGF-1).

III. To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).

IV. To determine the association between change in FACIT-F scores and changes in muscle function, day time activity, and body composition, in patients with advanced cancer receiving oral anamorelin 100 mg daily and standardized physical activity and nutritional counseling.

OUTLINE:

Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.

After completion of study treatment, patients are followed up on day 71.

Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors

Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer

FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.

The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level. We calculated the mean change in ESAS fatigue score from baseline to Day 43.

The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF general fatigue score from baseline to Day 43.

The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF physical fatigue score from baseline to Day 43.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.

Anamorelin

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Lung

Gastrointestinal

Breast

Gynecological

Head and Neck

Cancer Type

Full time

Retired

Homemaker

Unemployed

Not Reported

Employment Status

Divorced

Married

Single / never married

Widowed

Marital Status

Dr. Sriram Yennu, Professor, Palliative Care Med

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

The Edmonton Symptom Assessment Scale (ESAS)-Fatigue

Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue

Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue

Overall Study

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Carcinoma, Non-Small-Cell Lung

Anorexia

Lung Neoplasms

Wasting Syndrome

Cachexia

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Signs and Symptoms, Digestive

Thinness

100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

Placebo (administered as matching placebo tablets in the fasted condition)

Placebo Oral Tablet

Multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 316 patients with advanced NSCLC with cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 24 weeks. Patients will be instructed to take the study drug at least 1 hour before their first meal of the day

Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Mean change in 5-item Anorexia Symptom Subscale

Duration of treatment benefit in weight (≥0).

Duration of treatment benefit in weight (≥ to a predefined threshold).

Duration of treatment benefit in anorexia symptoms (≥0), as measured by the 5-item Anorexia Symptom Subscale.

Duration of treatment benefit in 5-item Anorexia Symptom Subscale (≥ to a predefined threshold).

Mean change in FAACT 12-item A/CS domain.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors	NCT03035409	Advanced Malign... C-Reactive Prot... Cancer Fatigue Metastatic Mali... Recurrent Malig... Weight Loss	Anamorelin Hydr... Exercise Interv... Laboratory Biom... Nutritional Ass... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT03743051	Cachexia; Cance... Non Small Cell ...	Anamorelin Hydr... Placebo Oral Ta...	18 Years -	Helsinn Healthcare SA

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