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

Conditions

• Advanced Colorectal Carcinoma
• Advanced Lung Non-Small Cell Carcinoma
• Advanced Pancreatic Adenocarcinoma
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Unresectable Colorectal Carcinoma
• Unresectable Lung Non-Small Cell Carcinoma
• Unresectable Pancreatic Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood and archived tumor samples
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT scan
• Electronic Health Record Review — OTHER
  Medical records reviewed
• Medical Device Usage and Evaluation — OTHER
  Wear actigraph
• Physical Performance Testing — OTHER
  Undergo physical function tests
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT scan
• Survey Administration — OTHER
  Complete surveys

Study Details

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.

Key Dates

Start date

Dec 4, 2023

Status verified

Jan 2026

Primary completion

Nov 13, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

800 participants (estimated)

Arms

• Arm: Observational (survey, function tests, biospecimen, actigraph)
  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 CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.

Primary Outcome Measure

Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC) [ Time Frame: Baseline through study completion, assessed up to 1 year follow up ]

Locations (225)

Find similar trials in Fort Smith, AR

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