Cancer Cachexia for Colorectal, Lung, and Pancreatic Cancer

(LOTUS-CC Trial)

Recruiting at 204 trial locations

Overseen By Ashley Mack, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester NCORP Research Base

Disqualifiers: Major surgeries, Pregnancy, Others

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

Compensation: Varies

Number of Visits: 2

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about cancer cachexia, a condition marked by weight, muscle, and fat loss in people with certain cancers. The study observes patients with advanced colorectal, lung, or pancreatic cancer to understand how cachexia affects them and how it might be treated more effectively in the future. Participants will complete surveys, undergo physical tests, provide blood samples, and wear a device to track daily activity. Patients with colorectal, lung, or pancreatic cancer that cannot be removed by surgery, and who are starting or have recently started cancer treatment, are suitable candidates for this study. As an unphased trial, this study offers patients the opportunity to contribute to foundational research that may improve future treatments for cancer cachexia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover subtypes of cancer cachexia, a condition where patients experience severe weight loss and muscle wasting. Unlike traditional treatments that mainly focus on managing symptoms, this study uses a combination of surveys, physical tests, blood samples, and actigraphs to gather a comprehensive set of data over time. By analyzing this data, researchers hope to identify distinct subtypes of cachexia, which could lead to more personalized and effective future treatments. This approach is unique because it prioritizes understanding the underlying mechanisms of the condition, rather than just addressing the symptoms.

Who Is on the Research Team?

Richard F Dunne, MD

Principal Investigator

University of Rochester NCORP Research Base

Are You a Good Fit for This Trial?

Inclusion Criteria

Cachexia is not a requirement for eligibility.

You have been diagnosed with inoperable or stage IV non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer.

You intend to initiate primary systemic anti-cancer treatment (chemotherapy, immunotherapy, targeted therapy or a clinical trial) within the next 6 weeks or have just commenced such treatment in the prior 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete surveys, undergo physical function tests, collection of blood and archived tumor samples, and wear actigraph for 7 days

1 week

1 visit (in-person)

3-Month Follow-up

Participants undergo follow-up assessments including surveys, physical function tests, and actigraph monitoring

1 week

1 visit (in-person)

1-Year Follow-up

Participants' medical records are reviewed and standard of care PET/CT scans are conducted

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Observational Research Study

How Is the Trial Designed?

Group I: Observational (survey, function tests, biospecimen, actigraph) Experimental Treatment 7 Interventions

Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base

Lead Sponsor

Trials

14

Recruited

9,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+