Gynecologic Cancer, Stage I Breast Cancer, Stage I Colorectal Cancer, Stage I Gynecologic Cancer, Stage II Breast Cancer, Stage II Colorectal Cancer, Stage II Gynecologic Cancer, Stage III Breast Cancer, Stage III Colorectal Cancer, Stage III Gynecologic Cancer, Stage III Prostate Cancer, Stage II Prostate Cancer, Stage I Prostate Cancer
Conditions
Keywords
Breast Cancer, Colorectal Cancer, Gynecologic Cancer, Acupuncture, Memorial Sloan Kettering Cancer Center, 19-179, Prostate Cancer
Brief summary
This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.
Interventions
OTHERAcupuncture
10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window
OTHERSham 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.
OTHER16 week waiting period + optional Acupuncture
Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) | 16 weeks | The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJun Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Outcome results
None listed