Study Summary
This trial will test whether electroacupuncture can help relieve chemotherapy-induced peripheral neuropathy pain.
Eligible Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Neuropathic Pain
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 8 weeks
4 weeks
Difference of pain severity from baseline to 4 weeks after baseline.
8 weeks
Difference of pain severity from baseline to 8 weeks after baseline.
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Sham Acupuncture (SA)
41%INCREASED DREAM ACTIVITY
24%REDUCED DURATION OF SLEEP:
17%DIMINISHED SEXUAL DESIRE
14%INCREASED DURATION OF SLEEP:
14%HEADACHE
14%ORGASMIC DYSFUNCTION
10%TENSION / INNER UNREST
10%CONSTIPATION
10%NAUSEA / VOMITING
10%CONCENTRATION DIFFICULTIES
10%ORTHOSTATIC DIZZINESS
7%ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
7%EMOTIONAL INDIFFERENCE
7%RASH
7%PHOTOSENSITIVITY
7%WEIGHT LOSS
3%SLEEPINESS / SEDATION
3%FAILING MEMORY
3%PARATHESIAS
3%INCREASED TENDENCY TO SWEATING
3%MENORRHAGIA
3%ERECTILE DYSFUNCTION
3%MICTURITION DISTURBANCES
3%ACCOMMODATION DISTURBANCES
3%EJACULATORY DYSFUNCTION
3%TREMOR
3%DIARRHEA
3%PALPITATIONS / TACHYCARDIA
3%PRURITUS
Trial Design
2 Treatment Groups
Electroacupuncture Arm
1 of 2
Sham Acupuncture Arm
1 of 2
Experimental Treatment
Non-Treatment Group
250 Total Participants · 2 Treatment Groups
Primary Treatment: Electroacupuncture · Has Placebo Group · Phase 3
Electroacupuncture Arm
Device
Experimental Group · 1 Intervention: Electroacupuncture · Intervention Types: DeviceSham Acupuncture Arm
Device
PlaceboComparator Group · 1 Intervention: Sham Acupuncture · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroacupuncture
2012
Completed Phase 3
~1800
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,288 Total Patients Enrolled
1 Trials studying Chemotherapy-induced Peripheral Neuropathy
75 Patients Enrolled for Chemotherapy-induced Peripheral Neuropathy
Ting Bao, MD, DABMA, MSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
371 Total Patients Enrolled
1 Trials studying Chemotherapy-induced Peripheral Neuropathy
75 Patients Enrolled for Chemotherapy-induced Peripheral Neuropathy
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are taking a stable regimen of anti-neuropathy or other pain medications.
You have self-reported moderate to severe CIPN pain over the past week.
You are willing to comply with all study-related procedures, including randomization to one of the two possible acupuncture treatments.
Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Memorial Sloan - Kettering Cancer Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments