Sound Acupuncture in Painful Chemotherapy-Related Neuropa... | NCT07187986

Studies
Sound Acupuncture in Painful Chemotherapy-Related Neuropathies

NCT07187986

Sponsor

Ente Ospedaliero Ospedali Galliera

Status

Completed

Last Update Posted

Sep 23, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Neuropathic Pain in Cancer

Interventions

Sound acupuncture

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2022Actual

Primary Completion Date

Jul 15, 2025Actual

Completion Date

Jul 16, 2025Actual

First Submitted Date

Aug 4, 2025

First Submission Date that Met QC Criteria

Sep 16, 2025

First Posted Date

Sep 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this clinical trial is to evaluate the efficacy of sound acupuncture in combination with traditional medical therapy in the treatment of chemotherapy-induced peripheral neuropathies.

Sound acupuncture is a non-invasive technique that involves stimulating energy points, used in acupuncture, with the help of specific tuning forks and the frequencies they emit.

The energy points are those used in Chinese medicine and, more specifically, in acupuncture.

The aim is to restore the recipient's complex bioenergetic system to an optimal state of well-being and balance

Participants:

20 patients will receive only the best medical therapy; 20 patients will receive BMT and sound acupuncture treatment

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sound acupuncture	Experimental	Best medical therapy + Sound Acupuncture	Other: Sound acupuncture
BMT	No Intervention	Best medical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sound acupuncture	Other	Best medical therapy + soundpuncture	Sound acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain reduction	At least a 30% reduction from baseline on the NPS scale for neuropathic pain	1 year

Secondary Outcomes

Measure	Description	Time Frame
Back Depression inventory	Effectiveness of sound therapy combined with pharmacological treatment through administration of the BDI-II scale	1 year
Quality of life assessment	EQ-5D scale for assessing the impact on quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 30-80 years
Clinical and electrophysiological diagnosis of chemotherapy-induced neuropathy
Patients being treated with Best Medical Therapy for neuropathic pain
Written informed consent

Exclusion Criteria:

Women who are pregnant or breastfeeding
Patients with intellectual disabilities or cognitive impairment that impair their ability to comply with the consent process
Pacemaker users

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
E.O. Ospedali Galliera		Genoa	Liguria	16128	Italy