NCT03998202 Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
| NCT ID | NCT03998202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2019-09-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2019-09-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Glenn Lesser, MD
STUDY CHAIR
WFUSM
Frequently Asked Questions
Who can join the NCT03998202 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03998202 currently recruiting?
Yes, NCT03998202 is actively recruiting participants. Contact the research team at NCORP@wfusm.edu for enrollment information.
Where is the NCT03998202 trial being conducted?
This trial is being conducted at Millville, United States, Newark, United States, Newark, United States, Rehoboth Beach, United States and 11 additional locations.
Who is sponsoring the NCT03998202 clinical trial?
NCT03998202 is sponsored by Wake Forest University Health Sciences. The principal investigator is Glenn Lesser, MD at WFUSM. The trial plans to enroll 300 participants.
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