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

NCT03035409 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: 2016-0655NCI-2017-00188
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Solid Neoplasm; C-Reactive Protein Measurement; Cancer Fatigue; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Weight Loss

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline up to day 43

Secondary Outcomes (3)

• The Edmonton Symptom Assessment Scale (ESAS)-Fatigue

  Baseline up to day 43

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

  Baseline up to day 43

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

  Baseline up to day 43

Study Arms (1)

Supportive Care (anamorelin, physical activity, counseling)

EXPERIMENTAL

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.

Drug: Anamorelin Hydrochloride; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Nutritional Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Anamorelin Hydrochloride DRUG

Given PO

Also known as: RC-1291 HCl

Supportive Care (anamorelin, physical activity, counseling)

Exercise Intervention BEHAVIORAL

Undergo physical activity

Supportive Care (anamorelin, physical activity, counseling)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive Care (anamorelin, physical activity, counseling)

Nutritional Assessment OTHER

Undergo nutritional counseling

Also known as: Dietary Assessment, dietary counseling, nutritional counseling

Supportive Care (anamorelin, physical activity, counseling)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (anamorelin, physical activity, counseling)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (anamorelin, physical activity, counseling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
• Presence of fatigue on FACIT-F subscale of =\< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
• Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
• CRP must be \>= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
• No evidence of moderate to severe depression as determined by a HADS depression score of =\< 13
• Presence of unintentional weight loss ranging from \>= 2 - =\< 15% in last 12 months
• Uncontrolled pain; if patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (\> 25%) for at least 48 hours prior to study entry; the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by the principal investigator (PI); change in opioid dose after study entry is allowed
• Patient must be willing to engage in telephone follow up with research staff
• Patient must have telephone access to be contacted by the research staff
• Hemoglobin level of \>= 9 g/dL
• Estimated life expectancy of \> 4 months at the time of screening
• Aspartate transaminase (AST) and alanine transaminase (ALT) levels =\< 5 x upper limit of normal (ULN)

You may not qualify if:

• Major contraindications to anamorelin e.g. hypersensitivity
• Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
• Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
• Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-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 need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls 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
• Male patients with a history of untreated hypogonadism
• 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 with untreated clinically relevant hypothyroidism
• Patients currently on investigational therapies will be evaluated by the PI on a case by case basis and study participation approval will be obtained from the treating oncologist
• Patients with prostate cancer

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Yennurajalingam S, Basen-Engquist K, Reuben JM, Fellman BM, Shete S, Maddi R, Williams JL, Dev R, Hui D, Bruera E. Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study. Support Care Cancer. 2022 Jan;30(1):497-509. doi: 10.1007/s00520-021-06463-8. Epub 2021 Jul 31.

  PMID: 34331589 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasm Metastasis; Weight Loss

Interventions

anamorelin; Nutrition Assessment

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Sriram Yennu, Professor, Palliative Care Med
• Organization: UT MD Anderson Cancer Center

syennu@mdanderson.org

(713) 792-3938

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: February 8, 2017
• Primary Completion: December 27, 2019
• Study Completion: February 28, 2026
• Last Updated: November 10, 2025
• Results First Posted: February 3, 2022

Record last verified: 2025-11

Locations

US (1)