Clinical trial NCT04837820: The Effect of Acupuncture on Cancer-Related Cognitive Difficulties
Official title: Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Acupuncture
Cancer-Related Cognitive Difficulties
20-124
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: 3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether acupuncture can improve cognitive difficulties and insomnia in survivors of breast cancer. Researchers will compare the effects of real acupuncture with those of placebo acupuncture and wait-list acupuncture. This study will also look at insomnia's link to cognitive difficulties.

All study participants (receiving real acupuncture, placebo acupuncture, or wait-list acupuncture) will complete study questionnaires and/or have cognitive testing at Weeks 0, 4, 10, 14 and 26. After the Week 26 visit, your participation in this study will end. If you are assigned to receive placebo acupuncture or wait-list acupuncture, you will have the option of receiving up to 10 real acupuncture treatments within the six months after the study finishes.


Eligibility criteria: Inclusion Criteria:

* English-proficient adult women with a history of stage 0, I, II, or III breast cancer
* Free of oncologic disease by clinical examination or history
* Moderate or greater CRCD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)
* Report that cognitive functions worsened since cancer diagnosis by replying "Yes" to all 3 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?
* Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134
* Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control

Exclusion Criteria:

* Metastatic breast cancer (stage IV)
* Less than 1 month since completion of surgery, chemotherapy or radiation therapy
* Greater than 10 years since most recent breast cancer diagnosis
* Use of acupuncture for sleep or 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 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135
* Primary psychiatric disorder not in remission
* As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation.
* Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments
* Initiation or change in hormonal or targeted therapy within the past 4 weeks
* Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks
* Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks
* Enrolled or plans to enroll on another MSK neurocognitive study
* Unable to provide informed consent for himself/herself

Primary outcomes:
measure: cognitive difficulties
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: