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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

Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 26, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date September 23, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2019)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03998202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 21, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Official Title Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood obtained for DNA extraction
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.
Condition
  • Colorectal Cancer
  • Sarcopenia
Intervention Not Provided
Study Groups/Cohorts
  • Adults 65-74 years
  • Adults >= 75 years
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 21, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Karen Craver 336-716-0891 NCORP@wakehealth.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Wake Forest University Health Sciences
Study Sponsor Wake Forest University Health Sciences
Collaborators University of Alabama at Birmingham
Investigators
Principal Investigator: Grant R Williams, MD University of Alabama at Birmingham
PRS Account Wake Forest University Health Sciences
Verification Date October 2019