What side effects are associated with this type of intervention?

Ruxolitinib, a JAK/STAT pathway inhibitor, is being studied for its effects on cancer cachexia. Common side effects of JAK/STAT inhibitors like Ruxolitinib include anemia, thrombocytopenia, and neutropenia, which are related to its impact on blood cell production. Other potential side effects are increased risk of infections, elevated liver enzymes, and gastrointestinal symptoms such as diarrhea and nausea. Broadly, treatments for cachexia may also cause fatigue, muscle weakness, and metabolic disturbances.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting the JAK/STAT pathway for the treatment of cachexia. Ruxolitinib, a JAK1/2 inhibitor, is currently being studied for its potential in treating cachexia in non-small cell lung cancer (NSCLC) patients. Broadly, treatments for cachexia have included appetite stimulants, anti-inflammatory agents, and anabolic agents, but none have specifically targeted the JAK/STAT pathway.

What other types of research exist?

Promising alternatives to Ruxolitinib for cachexia patients include: 1) Anamorelin, a ghrelin receptor agonist that has shown efficacy in improving appetite and lean body mass in cancer cachexia patients. 2) Enobosarm, a selective androgen receptor modulator (SARM) that has demonstrated potential in increasing muscle mass and physical function. 3) L-Carnitine, which has been studied for its role in improving muscle function and reducing fatigue in cachexia patients. These alternatives target different mechanisms involved in cachexia and have shown promising results in clinical studies.

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JAK Inhibitor

Ruxolitinib for Non-Small Cell Lung Cancer Cachexia

Q: What is the mechanism of action of this treatment?

Cachexia treatments often target the underlying mechanisms of inflammation and appetite regulation. Appetite stimulants like ghrelin mimetics (e.g., anamorelin) increase food intake and lean body mass. Inhibitors of the JAK/STAT pathway, such as Ruxolitinib, reduce inflammation and muscle degradation by blocking the inflammatory response that contributes to cachexia. These treatments are crucial as they address the multifaceted nature of cachexia, aiming to improve patient quality of life and overall outcomes.

Phase < 1

Recruiting

Led By Tu Dan, MD

Research Sponsored by Tu Dan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Ruxolitinib, a medication taken by mouth, in patients with advanced lung cancer who suffer from severe weight loss. The drug works by blocking certain signals in the body to help reduce this weight loss and muscle wasting. Ruxolitinib has shown effectiveness in improving symptoms and quality of life in patients.

Who is the study for?

Adults with advanced Non-Small Cell Lung Cancer and cachexia can join this trial. They must have a life expectancy of at least 6 months, no prior treatment for their lung cancer, and agree to use contraception. Those with certain mutations or other active cancers, previous JAK inhibitor treatments, or serious health issues like heart failure are excluded.

What is being tested?

The trial is testing the safety of Ruxolitinib in treating cachexia in lung cancer patients. It aims to find any toxic effects from different doses and see how it affects signaling pathways related to muscle and fat tissue before and after treatment.

What are the potential side effects?

Potential side effects include reactions similar to those seen with drugs that affect immune signaling pathways such as changes in blood counts, risk of infections, liver function alterations, and possibly others not yet known due to the investigational nature of the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of non-small cell lung cancer cachexia patients with toxicity with the use of Ruxolitinib

Secondary study objectives

Analysis of any preliminary evidence suggesting that Ruxolitinib improves overall survival in cancer cachexia patients.

Analysis of any preliminary evidence suggesting that Ruxolitinib suppresses adipose and lean muscle loss in cancer cachexia patients.

Analysis of any preliminary evidence suggesting that Ruxolitinib suppresses anorexia in cancer cachexia patients.

+4 more

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: Dosing Regimen for RuxolitinibExperimental Treatment1 Intervention

Level 0: Ruxolitinib 0 MG po bid for 1 month (Month 1) Level 1: Ruxolitinib 10 MG po bid for 1 month (Month 2) Level 2: Ruxolitinib 15 MG po bid for 1 month (Month 3)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cachexia treatments often target the underlying mechanisms of inflammation and appetite regulation. Appetite stimulants like ghrelin mimetics (e.g., anamorelin) increase food intake and lean body mass. Inhibitors of the JAK/STAT pathway, such as Ruxolitinib, reduce inflammation and muscle degradation by blocking the inflammatory response that contributes to cachexia. These treatments are crucial as they address the multifaceted nature of cachexia, aiming to improve patient quality of life and overall outcomes.

Sex and Gender Differences in Anticancer Treatment Toxicity: A Call for Revisiting Drug Dosing in Oncology.Do body composition parameters correlate with response to targeted therapy in ER+/HER2- metastatic breast cancer patients? Role of sarcopenia and obesity.Systematic review of the treatment of cancer-associated anorexia and weight loss.