Phase II Study of Low-Dose Ibuprofen for Cognitive Problems in Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 169
- 主要终点
- Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment
研究概览
简要总结
This randomized phase II trial studies how well low-dose ibuprofen in improving cognitive impairment in patients with cancer. Anti-inflammatory agents, such as ibuprofen, may slow the decline of cognitive processes and diseases involving the brain.
详细描述
PRIMARY OBJECTIVES:
I. To provide preliminary data on the effect of ibuprofen on alleviating chemotherapy-related cognitive impairment (CRCI) in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control, as assessed by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients receive ibuprofen orally (PO) twice daily (BID) for 6 weeks.
ARM II: Patients receive placebo PO BID for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of cancer and have had surgery and are now receiving adjuvant or neoadjuvant chemotherapy or who have received chemotherapy within the last 6 months; chemotherapy with concurrent radiation therapy (RT) is allowed
- •Answer YES to the question: "Have you noticed any problems in your memory, attention, concentration, multi-tasking or other cognitive functions?" any time after initiation of chemotherapy cycle 1
- •NOTE: If a participant answers NO, they may be re-approached at a subsequent cycle
- •Be able to swallow medication
- •Be able to read English
- •Have the ability to understand and to give written informed consent as assessed by the participant's primary care physician or medical oncologist
排除标准
- •Have a confirmed brain tumor or brain metastases
- •Be taking a regular daily dose of an NSAID NOTE: Daily doses of 81 mg aspirin are permitted and higher doses of an NSAID on an 'as needed' basis are permitted
- •Be diagnosed with dementia or severe neurodegenerative disease
- •Have a contraindication to NSAIDs at the oncologist's discretion (i.e., allergy, worsening of ongoing medical problem due to NSAID, very low platelet count from chemotherapy, full-dose anti-coagulation/high risk of bleeding, and uncontrolled conditions such as hypertension, asthma, or peptic ulcer disease)
- •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
- •Have active substance abuse (e.g. alcohol, drugs) per self-report or medical record
研究组 & 干预措施
Arm I (ibuprofen)
Patients receive ibuprofen PO BID for 6 weeks.
干预措施: Ibuprofen (Drug)
Arm I (ibuprofen)
Patients receive ibuprofen PO BID for 6 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (placebo)
Patients receive placebo PO BID for 6 weeks.
干预措施: Placebo (Other)
Arm II (placebo)
Patients receive placebo PO BID for 6 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment
时间窗: Up to 41 days post-intervention
Will be assessed by the Functional Assessment of Cancer Therapy-Cognitive Function. Means, standard deviations, and 95% confidence intervals will be determined in order to estimate preliminary population variances and effect sizes. These statistical measures will be calculated by group for the Pre(Baseline) and Post(6 Weeks) measures of the Functional Assessment of Cancer Therapy-Cognitive Function scores as well as the change (post-pre) in the scores using the subjects that completed the study (complete case estimation). The complete case estimates will be compared to multiple imputation estimates based on all subjects that completed pre-intervention. An analysis of covariance will be run using Functional Assessment of Cancer Therapy-Cognitive Function post-intervention as the response. Higher scores indicate better function; range is 0 to 148.
次要结局
未报告次要终点
研究者
Michelle Janelsins, PhD, MPH
Associate Professor
University of Rochester NCORP Research Base