Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Diagnosed metastatic CRC or metastatic recurrence of CRC \>= 3 months (12 weeks) from diagnosis at 60 years or older.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Adults 60-74 years
Group B: Adults >= 75 years
Trial outcomes
Primary outcomes
1
Number of Chemotherapy Toxicities (Grade 3 - 5)
Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Time frame
Up to 6 months (after initiation of chemotherapy)Secondary outcomes
1
Overall Survival
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov