NCT06073431 LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
| NCT ID | NCT06073431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Advanced Colorectal Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2027-11-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2023-12-04 with a primary completion date of 2027-11-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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) or is stage IV. 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.
Eligibility Criteria
Inclusion Criteria: * 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 received 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 Exclusion Criteria: * 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
Contact & Investigator
Richard F Dunne
PRINCIPAL INVESTIGATOR
University of Rochester NCORP Research Base
Frequently Asked Questions
Who can join the NCT06073431 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Colorectal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06073431 currently recruiting?
Yes, NCT06073431 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Rochester to inquire about joining.
Where is the NCT06073431 trial being conducted?
This trial is being conducted at Fort Smith, United States, Aurora, United States, Boulder, United States, Boulder, United States and 11 additional locations.
Who is sponsoring the NCT06073431 clinical trial?
NCT06073431 is sponsored by University of Rochester. The principal investigator is Richard F Dunne at University of Rochester NCORP Research Base. The trial plans to enroll 800 participants.