Anamorelin + Exercise + Nutrition for Cancer-Related Fatigue

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP 3A4 inhibitors, Antiarrhythmics

Disqualifiers: Prostate cancer, Diabetes, Hypothyroidism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well anamorelin hydrochloride, a treatment for cancer-related fatigue, combined with exercise and nutritional counseling, reduces fatigue in patients with incurable solid tumors that have spread or recurred. The trial tests whether this combination can increase energy levels and reduce tiredness. It seeks patients with advanced cancer who have experienced fatigue for at least two weeks and have noticed unintentional weight loss in the past year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that anamorelin hydrochloride is generally safe and well-tolerated. In studies, fewer patients experienced tiredness, loss of appetite, and nausea when taking anamorelin compared to those who did not, suggesting a manageable safety profile.

Exercise programs are also safe for cancer patients. Studies indicate that exercise can reduce cancer-related tiredness without causing serious side effects and is often recommended as a beneficial practice for people with cancer.

Nutritional counseling, another part of this treatment plan, is also safe. Research has shown it can improve nutrition and help manage tiredness during cancer treatment. Overall, combining these treatments appears safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Anamorelin is unique because it directly targets cancer-related fatigue by leveraging its action as a ghrelin receptor agonist. Unlike standard treatments that primarily focus on managing symptoms through medications like corticosteroids or stimulants, anamorelin works by stimulating appetite and increasing lean body mass, which can help combat fatigue more effectively. Researchers are excited about this treatment because it combines the physiological benefits of anamorelin with structured physical activity and nutritional counseling, potentially offering a more holistic approach to improving the quality of life for cancer patients.

What evidence suggests that this trial's treatments could be effective for cancer-related fatigue?

In this trial, participants will receive a combination of anamorelin hydrochloride, exercise, and nutritional counseling. Research has shown that anamorelin hydrochloride can help reduce tiredness in cancer patients. Specifically, studies found that patients taking anamorelin experienced improved muscle mass and appetite, which are important for energy. Exercise, particularly a mix of aerobic and strength exercises, has also reduced cancer-related tiredness. Regular physical activity can increase muscle strength and fitness, helping people feel less tired. Although not always consistent, nutritional counseling has had some success in reducing tiredness by improving diet and eating habits. Combining these approaches may effectively manage cancer-related tiredness. ^{2 3 5 6 7}

Who Is on the Research Team?

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anamorelin hydrochloride orally once daily and undergo physical activity and nutritional counseling

6 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Anamorelin Hydrochloride
• Exercise Intervention
• Nutritional Counseling

Trial Overview 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.

How Is the Trial Designed?

Group I: Supportive Care (anamorelin, physical activity, counseling) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cancer-related fatigue is a common and persistent issue for survivors, significantly impacting their quality of life and potentially reducing survival rates, with inflammation playing a key role in its development.

While there is no gold-standard treatment for cancer-related fatigue, various interventions such as physical activity, psychosocial support, mind-body techniques, and pharmacological options have shown beneficial effects in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-related fatigue--mechanisms, risk factors, and treatments. Bower, JE.[2022]

Cancer-related fatigue (CRF) is a common and distressing symptom experienced by cancer patients throughout their journey, yet it is often underdiagnosed and poorly managed.

Evidence from controlled trials indicates that interventions like exercise, psycho-educational programs, and cognitive-behavioral therapy for insomnia are effective in treating CRF, highlighting the need for more rigorous studies to identify the best treatments for specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-related fatigue: state of the science. Mitchell, SA.[2010]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03035409?term=AREA%5BBasicSearch%5D(RC-1291)&rank=4

Study Details | NCT03035409 | Anamorelin Hydrochloride, ... Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors. Detailed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10564655/

Factors associated with early discontinuation of anamorelin ... Worse PS and low PNI were associated with early discontinuation of anamorelin. Longer survival time was observed in the continuation group.

3. asco.org asco.org/abstracts-presentations/ABSTRACT119980

Evaluation of quality of life from a phase II study ... MDASI individual item changes demonstrated improvements in key cancer-related symptoms including fatigue, and were consistent with the adverse event profile.

4. ar.iiarjournals.org ar.iiarjournals.org/content/45/3/865

Anamorelin in the Management of Cancer Cachexia In several randomized, double-blind, placebo-controlled clinical trials, anamorelin significantly improved lean body mass and appetite in patients with cancer ...

5. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2016-0655.html

Effects of Anamorelin on Cancer-Related-Fatigue in ... Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5834076/

ROMANA 3: a phase 3 safety extension study of ... ROMANA 3 was a safety extension study of two phase 3, double-blind studies that assessed safety and efficacy of anamorelin in advanced NSCLC patients with ...

7. academic.oup.com academic.oup.com/oncolo/article/30/7/oyaf167/8180720

Efficacy and safety of anamorelin in patients with metastatic ... Anamorelin improves cancer cachexia by increasing serum insulin-like growth factor 1 (IGF-1). The aim of this study was to evaluate the efficacy ...