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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

Must not have

Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening

Patients with untreated clinically relevant hypothyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 43

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My fasting blood sugar is not above 200 mg/dl.

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I have untreated hypothyroidism that affects my daily life.

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I am not taking medications that affect heart rhythm, like flecainide or quinidine.

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I am a male with untreated low testosterone levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 43

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fatigue

Secondary study objectives

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 study objectives

Inflammatory response of cytokines, c-reactive protein, and IGF-1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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