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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998202
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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
Groups and Cohorts
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Group/Cohort
Adults 65-74 years
Adults >= 75 years


Outcome Measures
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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:   65 Years and older   (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 >= 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 read and comprehend English (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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998202


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

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Karen Craver    336-716-0891    NCORP@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
University of Alabama at Birmingham
Investigators
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Principal Investigator: Grant R Williams, MD University of Alabama at Birmingham
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03998202    
Other Study ID Numbers: IRB00058811
NCI-2019-02514 ( Registry Identifier: NCI Trial Identifier [CTRP] )
WF-1806 ( Registry Identifier: LPO ID )
IRB00058811 ( Other Identifier: WF eIRB ID )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: 6 months after publication for a 2 year duration
Access Criteria: upon to request to NCORP@wakehealth.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Colorectal Cancer
Myopenia
Sarcopenia
Chemotherapy
Geriatric-Oncology
Additional relevant MeSH terms:
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Colorectal Neoplasms
Sarcopenia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms