NCI Community Oncology Research Program - Protocol Summary
URCC 16092 - "Phase II Study of Exercise and 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
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 09/18/2018 (20:17:16)
Cognitive impairment prevention in non-metastatic colorectal cancer, post resection, currently receiving adj chemo, 6 weeks of 200 mg BID ibuprofen or placebo +/- exercise or health education. DCP-001 Eligible
Treatment Plan (Supplied drug: ibuprofen/placebo)
Pre-Intervention Assessment days -5 to -1
Pre-Intervention Visit days -8 to -1
Treatment begins on day 0, the same day as adjuvant chemotherapy.
Ibuprofen 200 mg BID + Health Education for 6 weeks
Placebo + Health Education for 6 weeks
Placebo + EXCAP for 6 weeks
Ibuprofen 200 mg BID + EXCAP for 6 weeks
- 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 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 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 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.
- Not have confirmed metastatic disease.
- Not be diagnosed with a neurodegenerative disease.
- Not 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.
- Not be receiving radiation treatment during study intervention period.
- Not 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
- Not 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).
- Not 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.
- Not have had a myocardial infarction or other major heart complications within the past 6 months.
- 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 be colorblind.
- Not diagnosed alcoholism within the last 5 years.