Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults with advanced, incurable solid tumors (except prostate cancer) who are experiencing fatigue and unintentional weight loss. They must have a certain level of inflammation (CRP >= 3 mg/l), not be severely depressed or on high opioid doses, and have an expected lifespan over 4 months. Participants need phone access for follow-ups but can't join if they're already very active, pregnant, not using contraception, have uncontrolled diabetes or hypersensitivity to anamorelin.Inclusion Criteria
I have felt tired for at least 2 weeks.
My cancer pain is managed and I haven't changed my pain medication dose significantly in the last 2 days.
I have a phone to be contacted by the research team.
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Exclusion Criteria
Major contraindications to anamorelin e.g. hypersensitivity
Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
My fasting blood sugar is not above 200 mg/dl.
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Participant Groups
The study tests whether a combination of the drug anamorelin hydrochloride, physical activity routines, and nutritional counseling can reduce cancer-related fatigue in patients with metastatic or recurrent solid tumors. It involves regular check-ins via phone and assessments through questionnaires and lab tests to monitor changes in fatigue levels.
1Treatment groups
Experimental Treatment
Group I: Supportive Care (anamorelin, physical activity, counseling)Experimental Treatment6 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator