Last updated on May 2019

Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Non-metastatic Colorectal Cancer Receiving Chemotherapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Stage IIIA Colorectal Cancer AJCC v7 | Stage 0 Colorectal Cancer | Stage IIIB Colorectal Cancer | Stage IIA Colorectal Cancer | Stage IIA Colorectal Cancer AJCC v7 | Stage IIC Colorectal Cancer | Stage II Colorectal Cancer AJCC v7 | Stage IIC Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer | Stage III Colorectal Cancer AJCC v7 | Stage IIB Colorectal Cancer | Stage II Colorectal Cancer | Stage IIIC Colorectal Cancer AJCC v7 | Cognitive Impairment | Stage I Colorectal Cancer | Stage I Colorectal Cancer AJCC v6 and v7 | Stage IIIA Colorectal Cancer | Stage IIB Colorectal Cancer AJCC v7 | Stage III Colorectal Cancer | Stage 0 Colorectal Cancer AJCC v6 and v7 | Caregiver
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Have a primary diagnosis of non-metastatic colorectal cancer and have had surgery and are now receiving adjuvant or neoadjuvant chemotherapy; chemotherapy with concurrent radiation therapy (RT) is allowed
  • Report any level of cognitive difficulty to the question, ?Have you noticed any cognitive problems (such as in your memory, attention, concentration, multi-tasking) since your cancer diagnosis?? any time after initiation of chemotherapy cycle 1; participant must answer YES to this question; discussion about cognitive changes can occur with the participant and a caregiver; caregiver must be at least 21 years of age
  • NOTE: If a participant answers NO, you may re-approach them at a subsequent cycle
  • Be scheduled to receive oral or intravenous (IV) chemotherapy treatments over the next six weeks during the study intervention period; therapeutic clinical trial participants are allowed
  • Agree not to take a daily dosage of a non-steroidal anti-inflammatory drugs (NSAID) except 81 mg 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 on any given day)
  • 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

Exclusion Criteria:

  • 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
  • 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 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 to interfere with antiplatelet activities
  • Be colorblind
  • Diagnosed alcoholism within the last 5 years

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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