Trial Outcomes & Findings for Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors (NCT NCT03035409)

Last Updated: 2025-11-10

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

Baseline up to day 43

Results posted on

2025-11-10

Participant Flow

Patients with advanced cancer were recruited from the Supportive Care Center of MD Anderson Cancer Center with a fatigue score of \< =34 on a 0 to 52 scale (FACIT-F) present for a minimum of 2 weeks before screening. Participants were recruited between February 2017 and December 2019.

129 participants were enrolled in this study but 45 participants received the treatment. 84 participants did not receive treatment due to either screen failure or not eligible to receive treatment.

Participant milestones

Participant milestones
Measure	Anamorelin Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
Overall Study STARTED	45
Overall Study Day 15	28
Overall Study Day 29	28
Overall Study Day 43	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Anamorelin Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
Overall Study Adverse Event	5
Overall Study Death	2
Overall Study Withdrawal by Subject	2
Overall Study Non compliance	4
Overall Study Patient was jittery	1
Overall Study Did not like Questionnaire	1
Overall Study Aspartate Aminotransferase increased	1
Overall Study Did not like taking drugs	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anamorelin n=28 Participants Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants
Cancer Type Lung	17 Participants n=5 Participants
Cancer Type Gastrointestinal	6 Participants n=5 Participants
Cancer Type Breast	2 Participants n=5 Participants
Cancer Type Gynecological	2 Participants n=5 Participants
Cancer Type Head and Neck	1 Participants n=5 Participants
Employment Status Full time	12 Participants n=5 Participants
Employment Status Retired	8 Participants n=5 Participants
Employment Status Homemaker	1 Participants n=5 Participants
Employment Status Unemployed	5 Participants n=5 Participants
Employment Status Not Reported	2 Participants n=5 Participants
Marital Status Divorced	3 Participants n=5 Participants
Marital Status Married	21 Participants n=5 Participants
Marital Status Single / never married	2 Participants n=5 Participants
Marital Status Widowed	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to day 43

Outcome measures

Outcome measures
Measure	Anamorelin n=28 Participants Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	4.89 score on a scale Interval -0.18 to 9.96

SECONDARY outcome

Timeframe: Baseline up 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.

Outcome measures

Outcome measures
Measure	Anamorelin n=28 Participants Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
The Edmonton Symptom Assessment Scale (ESAS)-Fatigue	-0.81 score on a scale Interval -1.95 to 0.32

SECONDARY outcome

Timeframe: Baseline up 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.

Outcome measures

Outcome measures
Measure	Anamorelin n=28 Participants Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue	-3.46 score on a scale Interval -6.21 to -0.81

SECONDARY outcome

Timeframe: Baseline up to day 43

Outcome measures

Outcome measures
Measure	Anamorelin n=28 Participants Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue	-0.39 score on a scale Interval -2.34 to 1.56

Adverse Events

Anamorelin

Serious events: 0 serious events

Other events: 10 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anamorelin n=28 participants at risk Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.
Nervous system disorders Anorexia	21.4% 6/28 • adverse events were collected at baseline to Day 43
Nervous system disorders Insomnia	21.4% 6/28 • adverse events were collected at baseline to Day 43
Gastrointestinal disorders Nausea	25.0% 7/28 • adverse events were collected at baseline to Day 43
Nervous system disorders Dizziness	14.3% 4/28 • adverse events were collected at baseline to Day 43
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 4/28 • adverse events were collected at baseline to Day 43
Gastrointestinal disorders Abdominal Pain	10.7% 3/28 • adverse events were collected at baseline to Day 43
General disorders Fever	10.7% 3/28 • adverse events were collected at baseline to Day 43
General disorders Pain	3.6% 1/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Pain in Extremity	10.7% 3/28 • adverse events were collected at baseline to Day 43
Skin and subcutaneous tissue disorders Paresthesia	10.7% 3/28 • adverse events were collected at baseline to Day 43
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	10.7% 3/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Arthalgia	10.7% 3/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Back pain	10.7% 3/28 • adverse events were collected at baseline to Day 43
Gastrointestinal disorders Constipation	7.1% 2/28 • adverse events were collected at baseline to Day 43
Nervous system disorders Peripheral sensory neuropathy	7.1% 2/28 • adverse events were collected at baseline to Day 43
Skin and subcutaneous tissue disorders Rash maculopapular	7.1% 2/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Chest wall pain	3.6% 1/28 • adverse events were collected at baseline to Day 43
Respiratory, thoracic and mediastinal disorders Cough	7.1% 2/28 • adverse events were collected at baseline to Day 43
Eye disorders Dry eye	3.6% 1/28 • adverse events were collected at baseline to Day 43
Gastrointestinal disorders Dry mouth	7.1% 2/28 • adverse events were collected at baseline to Day 43
Skin and subcutaneous tissue disorders Dry skin	7.1% 2/28 • adverse events were collected at baseline to Day 43
Nervous system disorders Dysgeusia	7.1% 2/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Facial pain	7.1% 2/28 • adverse events were collected at baseline to Day 43
Injury, poisoning and procedural complications Fall	7.1% 2/28 • adverse events were collected at baseline to Day 43
Gastrointestinal disorders Flatulence	7.1% 2/28 • adverse events were collected at baseline to Day 43
Nervous system disorders Flushing	7.1% 2/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Gait disturbance	3.6% 1/28 • adverse events were collected at baseline to Day 43
Nervous system disorders Headache	7.1% 2/28 • adverse events were collected at baseline to Day 43
Vascular disorders Hypertension	7.1% 2/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Myalgia	7.1% 2/28 • adverse events were collected at baseline to Day 43
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	7.1% 2/28 • adverse events were collected at baseline to Day 43
Gastrointestinal disorders Vomiting	3.6% 1/28 • adverse events were collected at baseline to Day 43
Vascular disorders Hyponatremia	3.6% 1/28 • adverse events were collected at baseline to Day 43
Gastrointestinal disorders Diarrhea	17.9% 5/28 • adverse events were collected at baseline to Day 43
General disorders Fatigue	35.7% 10/28 • adverse events were collected at baseline to Day 43
Endocrine disorders Hyperglycemia	17.9% 5/28 • adverse events were collected at baseline to Day 43

Additional Information

Dr. Sriram Yennu, Professor, Palliative Care Med

UT MD Anderson Cancer Center

Phone: (713) 792-3938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place