NCT06073431: LOTUS

LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia

Recruiting now Last updated 9 January 2026

What this trial tests

trial testing Biospecimen Collection in Advanced Colorectal Carcinoma in 800 participants. Currently enrolling.

Timeline

4 December 2023

Primary endpoint
13 November 2027

30 September 2028

Quick facts

Lead sponsor	University of Rochester
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	800
Start date	4 December 2023
Primary completion	13 November 2027
Estimated completion	30 September 2028
Sites	225 locations across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Computed Tomography
• Electronic Health Record Review
• Medical Device Usage and Evaluation
• Physical Performance Testing
• Positron Emission Tomography
• Survey Administration

Conditions studied

• Advanced Colorectal Carcinoma — all drugs for Advanced Colorectal Carcinoma →
• Advanced Lung Non-Small Cell Carcinoma — all drugs for Advanced Lung Non-Small Cell Carcinoma →
• Advanced Pancreatic Adenocarcinoma — all drugs for Advanced Pancreatic Adenocarcinoma →
• Stage IV Colorectal Cancer AJCC v8 — all drugs for Stage IV Colorectal Cancer AJCC v8 →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Advanced Colorectal Carcinoma or Advanced Lung Non-Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Call to Improve Coding of Cancer-Associated Cachexia.
   Goncalves MD, Dunne RF, Moore AC, Phillips W, et al · · 2025 · cited 5× · PMID 39805066 · DOI 10.1200/op-24-00781
2. Cancer-Associated Cachexia: Bridging Clinical Findings with Mechanistic Insights in Human Studies.
   Koh K, Scott R, Cespedes Feliciano EM, Janowitz T, et al · · 2025 · cited 2× · PMID 40298389 · DOI 10.1158/2159-8290.cd-25-0293