Acupuncture for the Improvement of Cognitive Difficulties in Breast, Colorectal, and Gynecological Cancer Survivors, the CLARITY Study
- History of stage I, II, or III cancer (breast, colorectal, gynecological)
- Free of oncologic disease by clinical examination and history
- 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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (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 3 possible choices: acupuncture, sham acupuncture, or wait-list control
- Metastatic cancer (stage IV)
- Less than 3 months since completion of chemotherapy or radiation therapy
- Greater than 10 years since cancer diagnosis (breast, colorectal, gynecological)
- Use of acupuncture for 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
- Motor impairments that interfere with ability to write or use a keyboard
- Visual impairments (not correctable by glasses, contact lens, etc.) that interfere with ability to view images on a page or computer screen
- Auditory impairments (not correctable by hearing aids) that interfere with ability to comprehend verbal instructions
- Initiation or change in hormonal adjuvant therapy within the past 4 weeks
- Plans to initiate or change hormonal treatment in the coming 8 weeks
- Altered dose of somnogenic medication (e.g. hypnotics, sedatives, and/or antidepressants) in the past 8 weeks
I. To obtain preliminary data on the magnitude of effect of an acupuncture intervention to improve perceived cognitive difficulties (CD) among breast, colorectal, and gynecological cancer survivors.
I. To obtain preliminary data on the magnitude of effect of an acupuncture intervention to improve insomnia among cancer survivors.
II. To evaluate the association between sleep- and cognition-related outcomes.
III. To evaluate the safety of acupuncture for perceived CD and insomnia in cancer survivors.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo acupuncture over 30-45 minutes once weekly for up to 10 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16.
GROUP II: Patients undergo sham acupuncture over 30-45 minutes once weekly for up to 10 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16.
GROUP III: Patients are put on a wait-list and receive standard of care for 16 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16. After week 16, patients may optionally undergo acupuncture.
Trial Phase Phase II
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Jun J Mao
- Primary ID 19-179
- Secondary IDs NCI-2019-05719
- Clinicaltrials.gov ID NCT04007770