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Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
RECRUITINGSponsored by Wake Forest University Health Sciences
Actively Recruiting
SponsorWake Forest University Health Sciences
Started2019-09-23
Est. completion2026-12-31
Eligibility
Age60 Years+
Healthy vol.Accepted
Locations146 sites
View on ClinicalTrials.gov →
NCT03998202
Summary
This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.
Eligibility
Age: 60 Years+Healthy volunteers accepted
Inclusion Criteria: * Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC. * Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable. * Estimated life expectancy \>= 6 months. * Patients must be able to comprehend English or Spanish (for questionnaire completion). * Ability to understand and the willingness to sign a written informed consent document. * Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- \> 10%) body weight change in the previous 12 months are eligible for this study. Exclusion Criteria: * Patients enrolled on hospice. * Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \>= 3 months (12 weeks) prior to this disease disease recurrence and treatment). * Patients may not be receiving any other investigational agents. * No untreated brain metastases. Patients with treated brain metastases are eligible. * Patients on or planned to undergo radiation therapy in near future.
Conditions3
CancerColorectal CancerSarcopenia
Locations146 sites
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
302-623-4450lbarone@christianacare.org
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorWake Forest University Health Sciences
Started2019-09-23
Est. completion2026-12-31
Eligibility
Age60 Years+
Healthy vol.Accepted
Locations146 sites
View on ClinicalTrials.gov →
NCT03998202