Acupuncture Pilot Study for Cancer-related Cognitive Function

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2026-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Stage I Colorectal Cancer Stage II Colorectal Cancer Stage III Colorectal Cancer Gynecologic Cancer Stage I Gynecologic Cancer Stage II Gynecologic Cancer Stage III Gynecologic Cancer Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window

Sham Acupuncture (SA)

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

10 treatments of sham acupuncture over the course of 10 weeks with a +/- 7 day window. After the 16-week study concludes patients in this group will have the option of receiving up to 10 sessions of real acupuncture; however, these sessions must be completed within 6 months of study conclusion.

Wait-List Control

This arm is Closed to accrual.

Group Type OTHER

16 week waiting period + optional Acupuncture

Intervention Type OTHER

Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.

Interventions

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Acupuncture

10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window

Intervention Type OTHER

Sham Acupuncture

10 treatments of sham acupuncture over the course of 10 weeks with a +/- 7 day window. After the 16-week study concludes patients in this group will have the option of receiving up to 10 sessions of real acupuncture; however, these sessions must be completed within 6 months of study conclusion.

Intervention Type OTHER

16 week waiting period + optional Acupuncture

Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No