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

129 Participants Needed

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?

Research shows that exercise and nutritional counseling can help reduce cancer-related fatigue. Anamorelin, a drug used to increase appetite and muscle mass, may also contribute to reducing fatigue when combined with these interventions. ^{1 2 3 4 5}

Is the combination of Anamorelin, exercise, and nutrition safe for humans?

Anamorelin has been shown to be well tolerated in clinical studies, with no dose-limiting toxicities identified. It does not compromise overall survival in cancer patients and has been used safely in combination with other treatments. ^{1 6 7 8 9}

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. ^{1 2 3 4 10}

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of exercise training on cancer-related fatigue in colorectal cancer survivors: a systematic review and meta-analysis of randomized controlled trials. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Does exercise intensity matter for fatigue during (neo-)adjuvant cancer treatment? The Phys-Can randomized clinical trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Anamorelin hydrochloride in the treatment of cancer anorexia-cachexia syndrome. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The emerging role of anamorelin hydrochloride in the management of patients with cancer anorexia-cachexia. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Supplementary Oral Anamorelin Mitigates Anorexia and Skeletal Muscle Atrophy Induced by Gemcitabine Plus Cisplatin Systemic Chemotherapy in a Mouse Model. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Polyunsaturated Fatty Acids, Exercise, and Cancer-Related Fatigue in Breast Cancer Survivors. [2021]