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Ghrelin Receptor Agonist

Anamorelin + Exercise + Nutrition for Cancer-Related Fatigue

Phase 2
Waitlist Available
Led By Sriram Yennu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 43
Awards & highlights

Study Summary

This trial is testing anamorelin hydrochloride, physical activity, and nutritional counseling to see if it can help reduce cancer-related fatigue in patients with incurable solid tumors.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from anamorelin may include gastrointestinal symptoms like nausea or constipation, blood sugar increases which could affect diabetics more severely, muscle spasms or swelling due to fluid retention. Exercise might cause temporary soreness or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced cancer that has spread or cannot be cured, but it's not prostate cancer.
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I do not have moderate to severe depression.
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I often feel very tired.
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I have lost between 2% and 15% of my weight without trying in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 43 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue
Secondary outcome measures
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue
The Edmonton Symptom Assessment Scale (ESAS)-Fatigue
Other outcome measures
Inflammatory response of cytokines, c-reactive protein, and IGF-1

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anamorelin Hydrochloride
2019
Completed Phase 3
~350
Exercise Intervention
2016
Completed Phase 4
~1330

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,320 Total Patients Enrolled
28 Trials studying Fatigue
2,742 Patients Enrolled for Fatigue
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,517 Total Patients Enrolled
118 Trials studying Fatigue
18,402 Patients Enrolled for Fatigue
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,428 Total Patients Enrolled
4 Trials studying Fatigue
340 Patients Enrolled for Fatigue

Media Library

Anamorelin Hydrochloride (Ghrelin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03035409 — Phase 2
Fatigue Research Study Groups: Supportive Care (anamorelin, physical activity, counseling)
Fatigue Clinical Trial 2023: Anamorelin Hydrochloride Highlights & Side Effects. Trial Name: NCT03035409 — Phase 2
Anamorelin Hydrochloride (Ghrelin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03035409 — Phase 2
Fatigue Patient Testimony for trial: Trial Name: NCT03035409 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Nutritional Assessment a danger to people's health?

"While there is some data suggesting that this nutritional assessment is safe, as it is only a Phase 2 trial, there is no evidence yet of efficacy."

Answered by AI

Are investigators still actively looking for new participants for this research?

"This study is not currently looking for patients, though this could change in the future. The original posting was on February 8th, 2017 and there have been subsequent updates on October 20th, 2022. If you are interested in other studies, 2909 trials related to weight loss and 6 trial concerning Nutritional Assessment are currently underway."

Answered by AI

How many people are receiving care through this clinical trial?

"This study is not enrolling patients at the moment. The trial was first posted on February 8th, 2017 and has since had its last edit on October 20th, 2022. As of right now, there are 2909 other clinical trials actively recruiting patients for weight loss and 6 for Nutritional Assessment."

Answered by AI

What other papers exist that mention Nutritional Assessment?

"There are currently 6 active clinical trials researching the efficacy of Nutritional Assessment. Out of these, 3 are in Phase 3. The other 153 locations conducting research on this topic are located all over the world, with a significant number in Deszk, Bihor."

Answered by AI

What are the goals researchers hope to achieve with this clinical trial?

"The purpose of this 43-day trial is to observe changes in the Functional Assessment of Cancer Illness Therapy-Fatigue subscale score. Additionally, researchers will compare these results against changes in day time activity and fatigue scores from the Edmonton Symptom Assessment Scale (ESAS) and the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tired many other ways to lose this weight and it seems that nothing is working I even went to WW and it wasn't working for me. I have tired many over the counter pills to no success.
PatientReceived 1 prior treatment
Recent research and studies
~16 spots leftby Mar 2025