URCC 16092: Phase II of Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer

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FAST FACTS

URCC 16092: Phase II of Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer Patients Receiving Chemotherapy

Inclusion Criteria

Study participants must:

1. Be ≥ 18 years of age
2. Have a primary diagnosis of non-metastatic colorectal cancer and are now receiving adjuvant or neoadjuvant chemotherapy. Chemotherapy with concurrent RT is allowed.
3. 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.
4. Be scheduled to receive oral or IV chemotherapy treatments over the next six weeks during the study intervention period. Therapeutic clinical trial participants are allowed.
5. Agree not to take a daily dosage of an 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)
6. Have the approval of their treating physician to participate in exercise testing (i.e.,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).
7. 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).
8. Be able to swallow medication.
9. Be able to read English.
10. 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.
11. 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

Study participants must not:

1. Have confirmed metastatic disease.
2. Be diagnosed with a neurodegenerative disease.
3. 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.
4. 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
5. Have been hospitalized for treatment of a major psychiatric illness within the last five years.
6. Have a serum creatinine above 1.5 ULN (collected within the past 4 weeks). ULN is per institutional definition.
7. Concurrent administration of warfarin, full dose aspirin, clopidrogel, apixaban or other medications known to increase the risk of bleeding or to interfere with antiplatelet activities.
8. Be colorblind.
9. Diagnosed alcoholism within the last 5 years.

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