Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY

Memorial Sloan Kettering Cancer Center6 个研究点分布在 1 个国家目标入组 48 人2019年7月1日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Stage I Breast Cancer
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 48
试验地点: 6
主要终点: Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)
状态: 进行中（未招募）
最后更新: 11个月前

This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.

注册库

clinicaltrials.gov

开始日期

2019年7月1日

结束日期

2026年7月

最后更新

11个月前

研究类型

Interventional

研究设计

Parallel

性别

All

发起方

责任方

Sponsor

•English-speaking
•Age 18 ≥ years old
•Diagnosis (breast, colorectal, prostate or gynecological cancer)
•Completed initial cancer treatment (surgery, chemotherapy, and/or radiation therapy) at least one month prior to study enrollment (patients receiving maintenance cancer treatment with hormonal or targeted therapies are permitted)
•Must report moderate or greater perceived CD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration (item #20) and memory (item #25) on the EORTC QLQ-C30 instrument (version 3.0)
•Must indicate that their cognitive functions have worsened since their cancer diagnosis by replying "Yes" to all of the following questions:
•Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis?
•Do you think your mind isn't as sharp now as it was before your cancer diagnosis?
•Do you feel like these problems have made it harder to function on your job or take care of things around the home?
•Must be willing to adhere to all study-related procedures, including randomization to one of the 2 possible choices: acupuncture or sham acupuncture

•Active disease
•Use of acupuncture for cognitive symptom management within the past 3 months
•Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
•Score of ≥10 on the Blessed Orientation-Memory-Concentration (BOMC) screening instrument
•Primary psychiatric disorder not in remission
•Initiation or change in medication (e.g., hypnotics, sedatives, and/or antidepressants) in the past 8 weeks