The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04837820
Collaborator
(none)
260
Enrollment
4
Locations
3
Arms
47.8
Anticipated Duration (Months)
65
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Acupuncture
  • Procedure: Sham Acupuncture
  • Other: Wait-List Control (WLC)
  • Other: Questionnaires
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)
Actual Study Start Date :
Apr 6, 2021
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Acupuncture

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

Procedure: 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.

Other: Questionnaires
Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 4, 10, 14, and 26. Average time to complete the patient-reported outcomes (PROs) 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.

Placebo Comparator: Sham Acupuncture (SA)

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

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.

Other: Questionnaires
Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 4, 10, 14, and 26. Average time to complete the patient-reported outcomes (PROs) 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.

Experimental: 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).

Other: 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.

Other: Questionnaires
Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 4, 10, 14, and 26. Average time to complete the patient-reported outcomes (PROs) 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.

Outcome Measures

Primary Outcome Measures

  1. cognitive difficulties [26 weeks]

    measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) instrument. FACT-Cog is a 37-item questionnaire with 4 subscales: perceived cognitive difficulties, impact on quality of life, comments from others, and perceived cognitive abilities. The FACT-Cog perceived cognitive impairment subscale (Cronbach's α 0.94) will be the primary outcome for the study. A subscale score is calculated by summing the 18 items of the subscale. The subscale score ranges from 0 to 72.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)CommackNew YorkUnited States11725
2Memoral Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew YorkUnited States10604
3Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
4Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew YorkUnited States11553

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04837820
Other Study ID Numbers:
  • 20-124
First Posted:
Apr 8, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center

Study Results

No Results Posted as of Nov 19, 2021