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出境医 / 临床实验 / Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer (M&M)

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer (M&M)

Study Description
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.

Condition or disease
Colorectal Cancer Sarcopenia

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Group/Cohort
Adults 60-74 years
Adults >= 75 years
Outcome Measures
Primary Outcome Measures :
  1. 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 :
  1. 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.


Biospecimen Retention:   Samples With DNA
Whole blood obtained for DNA extraction

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed metastatic CRC or metastatic recurrence of CRC greater than 1 year from diagnosis at 65 years or older.
Criteria

Inclusion Criteria:

  • Newly diagnosed metastatic CRC or metastatic recurrence of CRC greater than 1 year from diagnosis at age >= 60y.
  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Contacts
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Contact: Karen Craver 336-716-0891 NCORP@wakehealth.edu

Locations
Show Show 107 study locations