Transcranial magnetic stimulation reduces pain and analgetic use in breast cancer patients

ISRCTN	ISRCTN13972712
DOI	https://doi.org/10.1186/ISRCTN13972712
Secondary identifying numbers	UH22030114

Submission date: 28/01/2023
Registration date: 17/03/2023
Last edited: 15/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Cancer patients commonly experience pain. Advanced breast cancer patients experience pain due to the involvement of other structures, as well as due to the cancer treatment. Transcranial magnetic stimulation (TMS) is a new non-invasive brain stimulation method for pain management. This treatment has been proven to decrease pain and increase beta-endorphin levels in other chronic pain patients. This research aimed to study the effect of TMS on pain intensity, opioid usage, and serum beta-endorphin levels in breast cancer patients.

Who can participate?
Inpatient and outpatient breast cancer patients, 19–60 years old

What does the study involve?
The P1 group receive TMS for 20 minutes. Five sessions of TMS are administered, with one session per day, by a researcher or assistant. The P2 group was the control group and received no TMS. All patients in both groups continued analgesic treatment according to their therapeutic dose.

What are the possible benefits and risks of participating?
The use of TMS for pain therapy has been widely carried out and has a satisfactory effect, especially in patients with chronic pain (pain for over 3 months) who do not improve with drug therapy even with high doses of opioids, which can cause unpleasant side effects. The use of TMS is expected to reduce pain so that the amount of drugs consumed also decreases. TMS is non-invasive so that the patient is more comfortable, and the dose can be adjusted, thus minimizing the side effects of TMS. Side effects that can occur include headache/neck pain (non-steroidal anti-pain drugs can be given). If hearing loss occurs the volume of the device can be reduced and the patient can be given earplugs during therapy. If the patient feels anxious and uncomfortable the SMT intervention is stopped and the patient is calmed and if a seizure occurs the SMT intervention is stopped and the patient is treated as a seizure patient. In this study, the usual dose was used for pain therapy. In addition, tools and medicines are prepared for handling emergency conditions according to standard procedures.

Where is the study run from?
Hasanuddin University Hospital, Makassar (Indonesia)

When is the study starting and how long is it expected to run for?
April 2022 to August 2022

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Nur Surya Wirawan, acoanestesi@yahoo.com

Contact information

Dr Nur Surya Wirawan
Principal Investigator

Jl. Perintis Kemerdekaan KM 11
Tamalanrea Indah
Tamalanrea
Kota Makassar
Sulawesi Selatan
Makassar
90245
Indonesia

Phone	+62 (0)811466603
Email	acoanestesi@yahoo.com

Study information

Study design	Prospective randomized controlled trial with a pre-test–post-test design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The effect of transcranial magnetic stimulation on pain intensity and opioid use in breast cancer patients and on serum beta-endorphin levels: a randomized controlled trial
Study acronym	TETMSPIOUBCPSBEL:RCT
Study objectives	Transcranial magnetic stimulation (TMS) reduces pain intensity and opioid usage and increases serum beta-endorphin levels in breast cancer patients.
Ethics approval(s)	Approved 12/04/2022, Ethical Committee of Human Biomedical Research of the Hasanuddin University Faculty of Medicine (Jl. Perintis Kemerdekaan Kampus, Tamalanrea Km.10, Makassar, Indonesia; +62 (0)411 5044671; agussalim.bukhari@yahoo.com), ref: 172. 1UN4.6.4.5.3U PP36/2022 and protocol UH22030114
Health condition(s) or problem(s) studied	Pain in breast cancer patients
Intervention	The P1 group received 10-Hz transcranial magnetic stimulation for 20 minutes, at 80% of the motor threshold, with 100 pulses/train to 20 pulses/session, and with a 50-second intertrain interval. A figure-of-8 coil was used to deliver stimulation at M1. Five sessions of transcranial magnetic stimulation were administered, with one session per day, by a researcher or assistant. The P2 group was the control group (receives no TMS). All patients in both groups continued analgesic treatment according to their therapeutic dose.
Intervention type	Procedure/Surgery
Primary outcome measure	Measured at baseline and after five sessions: 1. Pain intensity measured using a numerical rating scale (NRS) from 0-10 2. Opioid usage recorded using medical records 3. Serum beta-endorphin level measured using enzyme-linked immunosorbent assay (ELISA) kit for beta-endorphin
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	01/04/2022
Completion date	01/08/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	40
Total final enrolment	40
Key inclusion criteria	1. 19–60 years old 2. Used analgesics combined with opioids for pain 3. Agreed to enrol in the study
Key exclusion criteria	1. Current chemotherapy treatment containing alkaloids vinca, taxane, platinum-based preparations 2. Electrodes implanted inside the head 3. Cochlear implants 4. History of head trauma, seizure, or syncope 5. Brain lesions 6. On drug withdrawal 7. Pregnant during the study period 8. Patient left the study 9. Insufficient blood samples for evaluating serum beta-endorphins obtained
Date of first enrolment	13/04/2022
Date of final enrolment	01/06/2022

Locations

Countries of recruitment

Indonesia

Study participating centre

Hasanuddin University Hospital

Jl. Perintis Kemerdekaan No.KM 10
Tamalanrea Indah
Kec. Tamalanrea
Kota Makassar
Sulawesi Selatan
Makassar
90245
Indonesia

Sponsor information

Hasanuddin University
University/education

Jl. Perintis Kemerdekaan No.KM.10
Tamalanrea Indah
Kec. Tamalanrea
Kota Makassar
Sulawesi Selatan
Makassar
90245
Indonesia

Phone	+62 (0)811466603
Email	acoanestesi@yahoo.com
Website	http://www.unhas.ac.id/id/
"ROR"	https://ror.org/00da1gf19

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/02/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Nur Surya Wirawan (acoanestesi@yahoo.com).

Editorial Notes

15/03/2023: Trial's existence confirmed by the Ethical Committee of Human Biomedical Research of the Hasanuddin University Faculty of Medicine.