NCT07187986

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

August 4, 2025

Last Update Submit

September 16, 2025

Conditions

Neuropathic Pain in Cancer

Outcome Measures

Primary Outcomes (1)

  • Pain reduction

    At least a 30% reduction from baseline on the NPS scale for neuropathic pain

    1 year

Secondary Outcomes (2)

  • Back Depression inventory

    1 year

  • Quality of life assessment

    1 year

Study Arms (2)

Sound acupuncture

EXPERIMENTAL

Best medical therapy + Sound Acupuncture

Other: Sound acupuncture

BMT

NO INTERVENTION

Best medical therapy

Interventions

Sound acupunctureOTHER

Best medical therapy + soundpuncture

Sound acupuncture

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E.O. Ospedali Galliera

Genoa, Liguria, 16128, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 4, 2025

First Posted

September 23, 2025

Study Start

March 17, 2022

Primary Completion

July 15, 2025

Study Completion

July 16, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

IT(1)