Page 11 - Delaware Medical Journal - March/April 2020

WF1806: Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults with Colorectal Cancer: The M&M Study
The objectives of the trial are:
Primary Endpoint:
• To examine the association between low muscle mass (myopenia) at diagnosis with cumulative grades 3-5 chemotherapy toxicity in older adults (≥65 years) with newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC greater than one year from completion of treatment for non-metastatic CRC undergoing 5-fluorouracil (5-FU) based systemic chemotherapy.
Secondary Endpoints:
• To examine the association between low muscle mass (myopenia) at diagnosis with one-year overall survival in older adults (≥65 years) with metastatic CRC.
• To characterize muscle mass at baseline, and three and six months after initiation of systemic chemotherapy in older adults with metastatic CRC.
• Identify distinct trajectories of muscle mass over time in older adults with metastatic CRC and examine the association of trajectories with chemotherapy toxicity and one-year overall survival.
• To examine factors associated with myopenia at baseline and trajectories of muscle loss, including comorbidities, concomitant medications, nutrition, inflammation, physical activity, and age.
• Examine the role of germline genetic variants in moderating the association between muscle loss and cumulative grades 3-5 chemotherapy toxicity.
• To examine factors other than chronologic age that can affect toxicity rates and adverse events as identified using a cancer-specific geriatric assessment.
Eligibility:
• Older adults (age ≥ 65y) with either
· newly diagnosed metastatic CRC or
· newly recognized metastatic recurrence of CRC greater than one year from completion of treatment for non-metastatic CRC
• Planning to undergo first-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 ≥ six months.
• Patients must be able to read and comprehend English or Spanish (for questionnaire completion).
• 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.
• Both men and women (as applicable) and members of all races and ethnic groups are eligible for this trial.
Treatment:
You will be asked to fill out a survey and complete a set of strength tests at three times:
• Before treatment
• During your three-month doctor visit
• During your six-month doctor visit
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | March/April 2020 | Vol. 92 | No. 2 59