Electroacupuncture for Chemotherapy-induced Peripheral Neuropathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chemotherapy-induced Peripheral Neuropathy+1 MoreElectroacupuncture - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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
This histogram enumerates side effects from a completed 2007 Phase 2 trial (NCT00071110) in the Sham Acupuncture (SA) ARM group. Side effects include: INCREASED DREAM ACTIVITY with 41%, REDUCED DURATION OF SLEEP: with 24%, DIMINISHED SEXUAL DESIRE with 17%, INCREASED DURATION OF SLEEP: with 14%, HEADACHE with 14%.

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: Device
Sham Acupuncture Arm
Device
PlaceboComparator Group · 1 Intervention: Sham Acupuncture · Intervention Types: Device
Treatment
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 York100.0%
How old are they?
65+100.0%
What site did they apply to?
Memorial Sloan - Kettering Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%