Trials / Active Not Recruiting

Active Not RecruitingNCT03035409

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

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 129 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	Anamorelin Hydrochloride	Given PO
BEHAVIORAL	Exercise Intervention	Undergo physical activity
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Nutritional Assessment	Undergo nutritional counseling
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2017-02-08
Primary completion: 2019-12-27
Completion: 2026-02-28
First posted: 2017-01-30
Last updated: 2025-11-10
Results posted: 2022-02-03

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03035409. Inclusion in this directory is not an endorsement.