Colorectal Cancer, Cognitive Impairment (URCC 16092)

For a patient to be eligible for participation in this study, all of the following criteria must apply.

• Have a primary diagnosis of non-metastatic colorectal cancer and have had surgery and are now receiving adjuvant chemotherapy
• Report cognitive difficulties of 3 or higher (on a scale of 0 = 'Not Present' to 10 = 'As Bad As You Can Imagine') to the REDCap Screening Form question, "Are you currently experiencing any cognitive problems (such as in your memory, attention, concentration, multi-tasking) since your cancer diagnosis" at chemotherapy cycle 2 or after
• Be scheduled to receive at least 6 weeks of oral or intravenous (IV) chemotherapy during the study intervention period; therapeutic clinical trial participants are allowed
• Agree not to take a daily dosage of an non-steroidal anti-inflammatory drug (NSAID) except 81 mg cardioprotective aspirin for the 6-week intervention period; (higher doses of an NSAID on an "as needed" basis for acute pain management are permitted but should not exceed more than 1000 mg for one day per week)
• Have the approval of their treating physician to participate in exercise testing (i.e., 6-minute walk test) and a low to moderate intensity home-based walking and progressive resistance exercise program; (physician must sign eligibility checklist prior to registration)
• Have the approval of their treating physician to receive the 6 week ibuprofen/placebo regimen (200 mg twice a day and doses 8 hours apart); (physician must sign eligibility checklist prior to registration)
• Be able to swallow medication
• Be able to read English
• Not be pregnant or become pregnant during the study if the participant is a woman of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile); documentation of pregnancy can be taken from the medical record
• Have the ability to understand and to give written informed consent as assessed by the participant's primary care physician or medical oncologist

A patient will not be eligible for participation in this study if any of the following criteria apply.

• Have confirmed metastatic disease
• Be diagnosed with a neurodegenerative disease
• Have a history of peptic ulcer disease within the last 12 months unless adequately treated as assessed by the participant's primary care physician or medical oncologist
• Be receiving radiation treatment during study intervention period
• Be identified as in the maintenance (A) or action (B) stage of physical activity as assessed by the single-item Exercise Stages of Change and exercising at least 150 min/wk of moderate intensity physical activity
  • A. Maintenance stage: Participant exercises regularly and has been for MORE than 6 months
  • B. Action stage: Participant exercises regularly and has been for LESS than 6 months
  • C. Preparation stage: Participant does not exercise regularly but intends to in the next 30 days
  • D. Contemplation stage: Participant does not exercise regularly but intends to in the next 6 months
  • E. Pre-contemplation stage: Participant does not exercise regularly and does not intend to in the next 6 months
• Have a contraindication to NSAIDs at the oncologist's discretion (i.e., allergy, worsening of ongoing medical problem due to NSAID, low platelet count from chemotherapy, and uncontrolled condition such as hypertension or asthma)
• Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in exercise testing (i.e., 6-minute walk test) or a low to moderate home-based walking and progressive resistance program, as assessed by the oncologist
• Have had a myocardial infarction or other major heart complications within the past 6 months
• Have been hospitalized for treatment of a major psychiatric illness within the last five years
• Have a serum creatinine above 1.5 upper limit of normal (ULN) (collected within the past 4 weeks); ULN is per institutional definition
• Concurrent administration of warfarin, full dose aspirin, clopidogrel, apixaban or other medications known to increase the risk of bleeding or with antiplatelet activities
• Be colorblind
• Diagnosed alcoholism within the last 5 years

To learn more, visit ClinicalTrials.Gov

Study Type

Phase II

Sponsor(s)

Gary Morrow