Female Breast CancerAlgocareNCT06331793
Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
A study testing Active AlgoCare and Non-active AlgoCare in people with Female Breast Cancer and Post Operative Pain, run by European Institute of Oncology at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Breast Cancer, Post Operative Pain
- What is being tested?
- Active AlgoCare and Non-active AlgoCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Daniele Sances, MD, +390257489618, daniele.sances@ieo.it
About this study
Official title: Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
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.
Read the detailed description
The treatment of postoperative pain is a priority issue for both the doctor and the patient. Obtaining adequate analgesia in the first postoperative days, in fact, is essential for the patient's comfort, but also to promote and accelerate functional recovery and prevent chronic pain, which in the case of breast surgery has a high incidence (20-60 %).
The use of pulsed electromagnetic fields (PEMF) for the treatment of pain and inflammation has been widely studied and validated.
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. This is a field of application in which this technique analgesic has never been tested, but in which it could prove valid within a multimodal analgesia protocol, as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound. AlgoCare is a non-invasive and non-pharmacological device, developed specifically for treatment of post-operative inflammation and pain, CE certified and registered with the Ministry of Health. It emits a pulsed radio frequency electromagnetic field at 27.1 MHz, a frequency already studied and approved for medical use.
- Conditions
- Female Breast Cancer, Post Operative Pain
- Being tested
- Active AlgoCare, Non-active AlgoCare
- Keywords
- Unilateral mastectomy with reconstruction, Post Operative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active AlgoCareDevice
Device that emits Pulsed Electromagnetic Fields
Non-active AlgoCareDevice
Device that doesn't emit Pulsed Electromagnetic Fields
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Non-active AlgoCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 72 hours
Secondary outcomes (5)
Need for analgesic drugs
Compare analgesic drugs use between the two arms
Measured: 3 months
Patient reported pain characteristics
Compare characteristics of pain between the two arms by collection of a questionnaire that describes kind of pain experienced by patient
Measured: 3 months
Number of participants with other symptoms
Compare presence of other symptoms between the two arms by collection of a questionnarie in which patient reports occurence of nausea, vomiting or other symptoms
Measured: 3 months
Need for other drugs
Compare use of drugs (other than analgesic ones) between the two arms
Measured: 3 months
Wound healing timing
Compare days needed to complete wound healing between the two arms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start9 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Sances, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331793
- Sponsor's protocol ID
- IEO 1849
- Acronym
- Algocare
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
- ClinicalTrials.gov ID
- NCT06331793
- Acronym / sponsor ID
- Algocare / IEO 1849
- Conditions
- Female Breast Cancer, Post Operative Pain
- Keywords
- Unilateral mastectomy with reconstruction, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The treatment of postoperative pain is a priority issue for both the doctor and the patient. Obtaining adequate analgesia in the first postoperative days, in fact, is essential for the patient's comfort, but also to promote and accelerate functional recovery and prevent chronic pain, which in the case of breast surgery has a high incidence (20-60 %).
The use of pulsed electromagnetic fields (PEMF) for the treatment of pain and inflammation has been widely studied and validated.
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. This is a field of application in which this technique analgesic has never been tested, but in which it could prove valid within a multimodal analgesia protocol, as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound. AlgoCare is a non-invasive and non-pharmacological device, developed specifically for treatment of post-operative inflammation and pain, CE certified and registered with the Ministry of Health. It emits a pulsed radio frequency electromagnetic field at 27.1 MHz, a frequency already studied and approved for medical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization 1:1
| Arm | Type | Receives |
|---|---|---|
| Active AlgoCare | Experimental | Device: Active AlgoCareAn 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. |
| Non-active AlgoCare | Placebo comparator | Device: Non-active AlgoCareA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active AlgoCareDevice that emits Pulsed Electromagnetic Fields | Device | Active AlgoCare |
| Non-active AlgoCareDevice that doesn't emit Pulsed Electromagnetic Fields | Device | Non-active AlgoCare |
Primary outcome
Pain intensity
Time frame: 72 hours
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)
5 secondary outcomes
Need for analgesic drugs
Time frame: 3 months
Patient reported pain characteristics
Time frame: 3 months
Number of participants with other symptoms
Time frame: 3 months
Need for other drugs
Time frame: 3 months
Wound healing timing
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Sances, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active AlgoCare and Non-active AlgoCare in people with Female Breast Cancer and Post Operative Pain, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniele Sances, MD (+390257489618, daniele.sances@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.