Trial Title:
An Observational Research Study to Uncover Subtypes of Cancer Cachexia, LOTUS-CC Study
NCT ID:
NCT06073431
Condition:
Cancer Cachexia (CC)
Conditions: Official terms:
Wasting Syndrome
Cachexia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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). 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.
Detailed description:
PRIMARY OBJECTIVE:
I. To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined
by host characteristics (e.g. cachexia symptoms, physical activity, physical function,
blood biomarkers including hemoglobin and albumin, and body composition) at baseline and
change in these factors over time in patients with cancer at high risk for CC.
SECONDARY OBJECTIVES:
I. To determine the association of each CC phenotype with overall survival. II. To
validate CC diagnostic phenotypes developed in a separate, independent cachexia
observational study performed by our collaborators at Kaiser Permanente.
III. To collect human samples of blood, tumor tissue, and medical images and build a
large, comprehensive CC database clinically annotated with cancer-related outcomes,
cachexia symptoms, and physical function data.
EXPLORATORY OBJECTIVE:
I. To evaluate for tumor-derived factors contributing to CC by determining the
association between interleukin-6 (IL-6) expression in tumors and IL-6 and CC chemokine
ligand 2 (CCL2) levels in the blood in patients with CC.
OUTLINE: This is an observational study.
Patients complete surveys over 30 minutes, undergo physical function tests over 30
minutes, undergo collection of blood and archived tumor samples, and wear actigraphy over
24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month
follow-up. Patients' medical records are also reviewed at baseline, 3-month and 1-year
follow-up.
Criteria for eligibility:
Study pop:
Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic
adenocarcinoma, colorectal cancer.
Sampling method:
Non-Probability Sample
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 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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Carle Cancer Center NCORP (CARLE)
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Cancer Research Consortium of West Michigan (CRCWM)
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Columbus NCORP (COLUMBUS)
Address:
City:
Columbus
Zip:
43215
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Cancer Research of Wisconsin and Northern Michigan Consortium (CROWN)
Address:
City:
Green Bay
Zip:
54301
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Aurora NCORP (AURORA)
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neha Glandt
Phone:
414-219-4718
Email:
neha.glandt@aah.org
Start date:
December 4, 2023
Completion date:
January 1, 2028
Lead sponsor:
Agency:
University of Rochester NCORP Research Base
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073431
