An Observational Research Study to Uncover Subtypes of Cancer Cachexia, LOTUS-CC Study (URCC-22063)

Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia

This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable). Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.

Accepting Participants

Observational

Symptom Management & Cancer Control

Learn More

To learn more, visit ClinicalTrials.Gov or contact Clinical Research at 864-560-6812.

Principal Investigator(s)

Michael Humeniuk, MD

Sponsor(s)

University of Rochester NCORP Research Base

Key Trial Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
- Note: Patients do not need to have cachexia to be eligible
  • Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
- NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended > 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or receive local therapy alone (surgery, radiation therapy [RT]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible
  - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  - Be able to understand, speak and read English
  - Be 18 years of age or older
A patient will not be eligible if any of the following criteria applies:
- Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
- Have any planned major surgeries within the next 3 months
- Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
- Be pregnant

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