Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer (M&M)
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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.
Condition or disease
This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.
Number of Chemotherapy Toxicities (Grade 3 - 5) [ Time Frame: Up to 6 months (after initiation of chemotherapy) ]
Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Secondary Outcome Measures :
Overall Survival [ Time Frame: 1 year ]
Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
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Ages Eligible for Study:
65 Years and older (Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosed metastatic CRC or metastatic recurrence of CRC greater than 1 year from diagnosis at 65 years or older.
Newly diagnosed metastatic CRC or metastatic recurrence of CRC greater than 1 year from diagnosis at age >= 65y.
Planning to undergo 1st line 5-FU based chemotherapy (as monotherapy [as 5-FU alone or capecitabine] or in combination with oxaliplatin and/or irinotecan +/- biologics).
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.
Patients enrolled on hospice.
Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed >= 12 months prior to disease recurrence).
Patients may not be receiving any other investigational agents.
No untreated brain metastases. Patients with treated brain metastases are eligible.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
6 months after publication for a 2 year duration
upon to request to NCORP@wakehealth.edu
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Wake Forest University Health Sciences:
Additional relevant MeSH terms:
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Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases