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Colorectal Cancer, Cognitive Impairment (URCC 16092)

Phase II Study of Exercise and Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer Patients Receiving Chemotherapy

Objective

Overview

   This randomized phase II trial studies how well exercise and low-dose ibuprofen in improving cognitive impairment in patients with colorectal cancer that has not spread to other places in the body who are receiving chemotherapy. Anti-inflammatory agents, such as ibuprofen, may slow the decline of cognitive processes and diseases involving the brain. Exercise may also help alleviating cognitive difficulties during chemotherapy.

Key Inclusion Criteria

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

Key Exclusion Criteria

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
IRB Protocol Number
URCC 16092
Principal Investigator(s)
Melanie Thomas

Clinical Trial Categories

  • Symptom Management & Cancer Control
  • Oncology
  • Gastrointestinal Cancer
Sponsor(s)
Gary Morrow
Contact
LaToya Davis at 864-560-0297
or ldavis@gibbscc.org
How to Participate

Latoya Davis

864-560-0297

ldavis@gibbscc.org

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