NCI Community Oncology Research Program - Protocol Summary
URCC 16092 - "Phase II Study of Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer Patients Receiving Chemotherapy"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Cancer Control Clinical Trial
CANCER TYPE: GI
RESEARCH BASE: URCC
NCT NUMBER: NCT03186638
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UPDATED ON 02/22/2019 (22:16:03)
Cognitive impairment prevention in non-metastatic colorectal cancer, post resection, currently receiving adj chemo, 6 weeks of 200 mg BID ibuprofen or placebo. DCP-001 Eligible
Treatment Plan (Supplied drug: ibuprofen/placebo)
Pre-Intervention Visit days -8 to 0
Treatment begins on day 0, the same day as adjuvant chemotherapy.
Ibuprofen 200 mg BID for 6 weeks
Placebo for 6 weeks
Post Intervention Visit day 41 +/- 3 days (Must be prior to last chemo cycle)
- Be ≥ 18 years of age
- Have a primary diagnosis of non-metastatic colorectal cancer and have had surgery and are now receiving adjuvant chemotherapy.
- 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 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.
- Be scheduled to receive at least 6 weeks of oral or IV chemotherapy during the study intervention period. Therapeutic clinical trial participants are allowed.
- Agree not to take a daily dosage of an 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 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.
- No confirmed metastatic disease.
- No neurodegenerative disease.
- No 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.
- No 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).
- Not have been hospitalized for treatment of a major psychiatric illness within the last five years.
- Not have a serum creatinine above 1.5 ULN (collected within the past 4 weeks). ULN is per institutional definition.
- No concurrent administration of warfarin, full dose aspirin, clopidrogel, apixaban or other medications known to increase the risk of bleeding or with antiplatelet activities.
- Not colorblind.
- Not diagnosed alcoholism within the last 5 years.