Page 11 - Delaware Medical Journal - January/February 2020

URCC 16092: Phase II Study of Low-Dose Ibuprofen for Cognitive Impairment in Cancer Patients Receiving Chemotherapy
The objectives of the trial are:
Primary Objective:
To provide preliminary data on the effect of ibuprofen on alleviating cancer-related cognitive impairment (CRCI) in cancer patients receiving chemotherapy compared to a placebo control, as assessed by the Functional Assessment of Cancer Therapy-Cognitive Function.
Secondary Objective:
• To provide preliminary data on the effect of ibuprofen on alleviating CRCI in cancer patients receiving chemotherapy compared to a placebo control by objective assessments of cognitive function. These are measured by validated neuropsychological assessment of verbal memory, attention, and executive function via CANTAB and paper-based measures.
• To provide preliminary data on the effect of ibuprofen on alleviating CRCI in cancer patients receiving chemotherapy compared to a placebo control on phone-based cognitive function measures.
• To provide preliminary data on the effect of ibuprofen on alleviating CRCI in cancer patients receiving chemotherapy compared to a placebo control on serum pro-inflammatory and anti-inflammatory cytokines/receptors in cancer patients receiving chemotherapy.
• To provide preliminary data on the mediating effects of cytokine/receptor concentrations on the CRCI changes due to ibuprofen in cancer patients receiving chemotherapy compared to placebo control.
Eligibility: Patients must:
Eligibility Criteria for Screening and Molecular Profiling (STEP 0):
• Be ≥ 18 years of age
• Be able to swallow medication.
• Have a primary diagnosis of cancer and currently be receiving chemotherapy. Chemotherapy with concurrent RT and other treatments 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 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 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.)
• 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.)
• 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.
Treatment:
Arm 1: Participants assigned to Treatment Arm 1 will receive a 6-week supply of ibuprofen (200 mg), which consists of 84 capsules of
ibuprofen to be taken twice daily.
Arm 2: Participants assigned to Treatment Arm 2 will receive a 6-week supply of placebo, which consists of 84 capsules of placebo to be taken twice daily. The placebo contains trace amounts of lactose (approximately 0.32 grams per capsule).
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | January/February 2020 | Vol. 92 | No. 1 11