Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Sarcopenia. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Number of Chemotherapy Toxicities (Grade 3 - 5) [Time frame: Up to 6 months (after initiation of chemotherapy)]
Secondary outcome measures (1)
- Overall Survival [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 146 centers
- Beebe South Coastal Health Campus — Millville
- Helen F Graham Cancer Center — Newark
- Medical Oncology Hematology Consultants PA — Newark
- Beebe Health Campus — Rehoboth Beach
- Christiana Care Health System-Wilmington Hospital — Wilmington
- MedStar Georgetown University Hospital — Washington D.C.
- John B Amos Cancer Center — Columbus
- Illinois CancerCare-Bloomington — Bloomington
- … and 138 more centers
Identifiers
NCT: NCT03998202 · IRB00058811 · NCI-2019-02514 · WF-1806 · IRB00058811