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Not Applicable
Acupuncture for Cancer-Related Cognitive Impairment
Phase 2
Waitlist Available
Led By Jun Mao, MD, MSCE
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Diagnosis of breast, colorectal, prostate, or gynecological cancer
Must not have
Active disease
Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Summary
This trial is exploring whether acupuncture can help improve cognitive difficulties in cancer patients by stimulating the body to heal itself.
Who is the study for?
This trial is for English-speaking adults over 18 who've finished initial cancer treatment at least a month ago and feel their memory or concentration has worsened since their diagnosis. They must not have active disease, recent acupuncture for cognition, certain psychiatric disorders, dementia, Parkinson's, or recent medication changes.
What is being tested?
The study tests if acupuncture can help with cognitive issues in cancer patients. Participants will be randomly assigned to receive either real acupuncture or sham (placebo) acupuncture. There's also an option of a waiting period followed by optional acupuncture.
What are the potential side effects?
Acupuncture may cause minor side effects like soreness or bruising at needle sites, fatigue, headache, and feeling dizzy during the session. Sham acupuncture involves non-penetrating needles which should have minimal to no side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with breast, colorectal, prostate, or gynecological cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My disease is currently active.
Select...
I have been diagnosed with a brain disorder such as Alzheimer's or Parkinson's.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)
Side effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Wait-List ControlExperimental Treatment1 Intervention
This arm is Closed to accrual.
Group II: AcupunctureExperimental Treatment1 Intervention
Group III: Sham Acupuncture (SA)Placebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,203 Total Patients Enrolled
207 Trials studying Breast Cancer
82,323 Patients Enrolled for Breast Cancer
Jun Mao, MD, MSCEPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
2,022 Total Patients Enrolled
1 Trials studying Breast Cancer
270 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My disease is currently active.I haven't started or changed any sleep, calm, or mood medications in the last 8 weeks.I finished my initial cancer treatment over a month ago but may be on maintenance therapy.I am willing to follow the study's procedures and accept being randomly assigned to real or sham acupuncture.I am 18 years old or older.I have been diagnosed with a brain disorder such as Alzheimer's or Parkinson's.I have used acupuncture for cognitive issues in the last 3 months.You score 10 or higher on a memory and concentration test called the Blessed Orientation-Memory-Concentration (BOMC) screening instrument.You have a mental health condition that is not under control.You must report having a lot of trouble concentrating or remembering on a specific questionnaire called the EORTC QLQ-C30.You have to say "Yes" to certain questions that show your thinking abilities have gotten worse since your cancer diagnosis.I have been diagnosed with breast, colorectal, prostate, or gynecological cancer.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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