Anamorelin + Exercise + Nutrition for Cancer-Related Fatigue
Trial Summary
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain drugs like strong CYP 3A4 inhibitors or medications that affect heart rhythms. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Anamorelin + Exercise + Nutrition for Cancer-Related Fatigue?
Is the combination of Anamorelin, exercise, and nutrition safe for humans?
How does the drug Anamorelin differ from other treatments for cancer-related fatigue?
Anamorelin is unique because it combines a daily oral medication with exercise and nutrition counseling to address cancer-related fatigue, whereas other treatments often focus on just one aspect, like exercise or dietary changes. This combination approach aims to tackle fatigue from multiple angles, potentially offering a more comprehensive solution.123410
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.
Research Team
Sriram Yennu
Principal Investigator
M.D. Anderson Cancer Center
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive anamorelin hydrochloride orally once daily and undergo physical activity and nutritional counseling
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Anamorelin Hydrochloride
- Exercise Intervention
- Nutritional Counseling
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator