The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Acupuncture

The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

Questionnaires

Intervention Type OTHER

Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 0, 10, and 26. Average time to complete the surveys is 30 minutes, which has been judged to be acceptable with minimal missing data; 20 minutes of these 30 minutes will be completed during the neurocognitive battery. Patients will complete PROs online using Research Electronic Data Capture (REDCap) or over the phone with the CRC. Biospecimens will be collected in person at assessment visits. The neurocognitive battery will be administered remotely.

Sham Acupuncture (SA)

The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.

Group Type PLACEBO_COMPARATOR

Sham Acupuncture

Intervention Type PROCEDURE

Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

Questionnaires

Intervention Type OTHER

Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 0, 10, and 26. Average time to complete the surveys is 30 minutes, which has been judged to be acceptable with minimal missing data; 20 minutes of these 30 minutes will be completed during the neurocognitive battery. Patients will complete PROs online using Research Electronic Data Capture (REDCap) or over the phone with the CRC. Biospecimens will be collected in person at assessment visits. The neurocognitive battery will be administered remotely.

Wait-List Control

During the 26-week waiting period, the CRC will contact patients in the WLC group at the same frequency as the acupuncture groups with respect to data collection. Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. WLC patients will be compensated with real acupuncture treatments after Week 26 (end of study).

Group Type EXPERIMENTAL

Wait-List Control (WLC)

Intervention Type OTHER

Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.

Questionnaires

Intervention Type OTHER

Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 0, 10, and 26. Average time to complete the surveys is 30 minutes, which has been judged to be acceptable with minimal missing data; 20 minutes of these 30 minutes will be completed during the neurocognitive battery. Patients will complete PROs online using Research Electronic Data Capture (REDCap) or over the phone with the CRC. Biospecimens will be collected in person at assessment visits. The neurocognitive battery will be administered remotely.

Interventions

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Acupuncture

Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

Intervention Type PROCEDURE

Sham Acupuncture

Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

Intervention Type PROCEDURE

Wait-List Control (WLC)

Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.

Intervention Type OTHER

Questionnaires

Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 0, 10, and 26. Average time to complete the surveys is 30 minutes, which has been judged to be acceptable with minimal missing data; 20 minutes of these 30 minutes will be completed during the neurocognitive battery. Patients will complete PROs online using Research Electronic Data Capture (REDCap) or over the phone with the CRC. Biospecimens will be collected in person at assessment visits. The neurocognitive battery will be administered remotely.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No