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Trial registered on ANZCTR


Registration number
ACTRN12624001390572
Ethics application status
Approved
Date submitted
18/10/2024
Date registered
22/11/2024
Date last updated
22/11/2024
Date data sharing statement initially provided
22/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of ultrasound-guided percutaneous neuromodulation for the treatment of chemotherapy-induced peripheral neuropathies. A randomized clinical trial
Scientific title
Efficacy of ultrasound-guided percutaneous neuromodulation on the quality of life in treating individuals with oxaliplatin-induced peripheral neuropathy
Secondary ID [1] 313172 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 335521 0
Condition category
Condition code
Cancer 332089 332089 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous Ultrasound-Guided Neuromodulation Group: The following steps will be undertaken:
1. Ultrasound Localization of the Nerve: A linear probe will be positioned on the anterior aspect of the elbow in a transverse plane. In this view, the median nerve will be visualized between the heads of the pronator teres muscle, medial to the brachial artery (1 min).

2. Selection of the Approach Type: Depending on the anatomical disposition of the nerve, either a short-axis approach (introducing the needle in a plane parallel to the probe) or a long-axis approach (introducing the needle from the medial end of the probe) may be employed (1 min).

3. Assessment of Safety Measures: Localization of surrounding veins and arteries will be conducted using the Doppler function of the ultrasound machine, along with measurement of the distance from the skin to the target nerve to determine the appropriate needle size (5 min).

4. Pre-Intervention Measures: Hand washing, donning gloves and a probe cover, and skin antisepsis using a chlorhexidine-based antiseptic will be performed (5 min).

5. Ultrasound-Guided Intervention: The needle will be inserted and advanced toward the target tissue with real-time visualization using ultrasound. The needle should be positioned within the epineurium of the median nerve. Subsequently, a transcutaneous electrode will be placed on the ventral aspect of the forearm, and a monopolar electrode will be connected to the needle, aiming to reproduce a motor or sensory response over the nerve (1 min).

6. Peripheral Nerve Electrostimulation: A peripheral nerve stimulator (Endomed 484) will be utilized to apply a continuous biphasic rectangular current, adjusting the frequency to 1-2 Hz and the pulse width to 200-250 µs. The intensity will be gradually increased to a tolerable threshold for the patient (the patient will be asked after each increase in intensity until the maximum point prior to reproducing pain is found) and maintained for the 30-minute duration of stimulation.
To ensure that the nerve is being correctly stimulated, involuntary contractions will be observed in the musculature that innervates and the patient will report a tingling sensation along the nerve territory.

7. Post-Intervention Measures: The needle will be withdrawn, followed by 30 seconds of compression with a sterile gauze (1 min).

The treatment will be performed in a treatment room of the hospital and will be applied by a physiotherapist with expertise in ultrasound.
Intervention code [1] 329797 0
Rehabilitation
Intervention code [2] 329884 0
Treatment: Devices
Comparator / control treatment
Placebo Group for Percutaneous Ultrasound-Guided Neuromodulation:
For participants randomized into the NMP-e placebo group, the same procedure as in the experimental group will be conducted; however, in this case, the external stimulator will remain turned off, so they will not receive nerve electrostimulation.
Control group
Placebo

Outcomes
Primary outcome [1] 339680 0
Quality of life
Timepoint [1] 339680 0
Pre-intervention, after completing 4 weeks of intervention and post-intervention (after completing the 12 weeks of treatment).
Secondary outcome [1] 440853 0
Neural sensitivity. This will be evaluated as a composite result.
Timepoint [1] 440853 0
Pre-intervention, after completing 4 weeks of intervention and post-intervention (after completing the 12 weeks of treatment).
Secondary outcome [2] 440854 0
Degree of neurotoxicity
Timepoint [2] 440854 0
Pre-intervention, after completing 4 weeks of intervention and post-intervention (after completing the 12 weeks of treatment).
Secondary outcome [3] 440855 0
Cumulative dose of oxaliplatin
Timepoint [3] 440855 0
Pre-intervention, after completing 4 weeks of intervention and post-intervention (after completing the 12 weeks of treatment).

Eligibility
Key inclusion criteria
Subjects over 18 years of age, diagnosed with a gastrointestinal malignancy and on an oxaliplatin-based chemotherapy regimen, who have experienced symptoms of chemotherapy-induced peripheral neuropathy and have life expectancy greater than 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have a history of peripheral neuropathy caused by reasons other than chemotherapy, are diagnosed with peripheral vascular disease, uncontrolled arrhythmias, epilepsy, Raynaud's syndrome, diabetes or severe mental disorders, pregnant women, belonephobia, participants in other clinical trials for the treatment of neuropathy, and patients who cannot communicate in Spanish.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central computer randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by means of a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26641 0
Spain
State/province [1] 26641 0

Funding & Sponsors
Funding source category [1] 317614 0
University
Name [1] 317614 0
Universidad Europea de Madrid
Country [1] 317614 0
Spain
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 319926 0
Hospital
Name [1] 319926 0
Hospital de Fuenlabrada
Address [1] 319926 0
Country [1] 319926 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316318 0
Fuenlabrada Hospital's Drug Research Ethics Committee
Ethics committee address [1] 316318 0
Ethics committee country [1] 316318 0
Spain
Date submitted for ethics approval [1] 316318 0
07/03/2023
Approval date [1] 316318 0
21/03/2023
Ethics approval number [1] 316318 0
23/02

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137510 0
Ms Sara Mogedano Cruz
Address 137510 0
Universidad Europea de Madrid - Calle Tajo s/n, Villaviciosa de Odón, 28670
Country 137510 0
Spain
Phone 137510 0
+34662222713
Fax 137510 0
Email 137510 0
sara.mogedano@universidadeuropea.es
Contact person for public queries
Name 137511 0
Sara Mogedano Cruz
Address 137511 0
Universidad Europea de Madrid - Calle Tajo s/n, Villaviciosa de Odón, 28670
Country 137511 0
Spain
Phone 137511 0
+34662222713
Fax 137511 0
Email 137511 0
sara.mogedano@universidadeuropea.es
Contact person for scientific queries
Name 137512 0
Sara Mogedano Cruz
Address 137512 0
Universidad Europea de Madrid - Calle Tajo s/n, Villaviciosa de Odón, 28670
Country 137512 0
Spain
Phone 137512 0
+34662222713
Fax 137512 0
Email 137512 0
sara.mogedano@universidadeuropea.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.