NCT06331793

Brief Summary

Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 9, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

March 18, 2024

Last Update Submit

March 22, 2024

Conditions

Female Breast CancerPost Operative Pain

Keywords

Unilateral mastectomy with reconstructionPost Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Difference in mean NRS score between the two arms, at 24 hours and 72 hours after surgery (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome)

    72 hours

Secondary Outcomes (5)

  • Need for analgesic drugs

    3 months

  • Patient reported pain characteristics

    3 months

  • Number of participants with other symptoms

    3 months

  • Need for other drugs

    3 months

  • Wound healing timing

    3 months

Study Arms (2)

Active AlgoCare

EXPERIMENTAL

An active AlgoCare device (that emits a pulsed radio frequency electromagnetic field at 27.1 MHz) will be placed over the surgical dressing using a plaster or bandage for six days.

Device: Active AlgoCare

Non-active AlgoCare

PLACEBO COMPARATOR

A non-active AlgoCare device (that doesn't emit pulsed radio frequency electromagnetic field) will be placed over the surgical dressing using a plaster or bandage for six days.

Device: Non-active AlgoCare

Interventions

Active AlgoCareDEVICE

Device that emits Pulsed Electromagnetic Fields

Active AlgoCare
Non-active AlgoCareDEVICE

Device that doesn't emit Pulsed Electromagnetic Fields

Non-active AlgoCare

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection

You may not qualify if:

  • Patients with PaceMakers (PMs), Implantable Cardioverter Defibrillators (ICDs), neurostimulators or other active medical devices or metal implants near the application area
  • Pregnancy
  • Amyloidosis, sarcoidosis, scleroderma, infectious arthritis, Paget's disease or joint tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Daniele Sances, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Sances, MD

CONTACT

+390257489618daniele.sances@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 26, 2024

Study Start

May 9, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

IT(1)