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Cancer SurvivorsNCT06230679

Effectiveness of NESA in the Treatment of Cancer Survivors

A study testing Non-invasive Neuromodulation in people with Cancer Survivors, run by Aníbal Báez Suárez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cancer is a disease, or a set of diseases, that increased in our society. However, improvements in their detection and treatment increase the number of patients who survive. Every year 2.6 million people are diagnosed in the European Union and 1.4 million become cancer survivors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cancer Survivors
What is being tested?
Non-invasive Neuromodulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSpain
Study dates
19 Jan 2024to 19 Dec 2025
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be a cancer survivor (5 years after discharge)
  • Have 1 of the 3 symptoms of the most common cluster: sleep problems, chronic fatigue, chronic neuro-muscular pain.

Who cannot join

  • Not have an active oncological process
  • Present any of the contraindications of the NESA-XSignal device: pacemaker, internal bleeding, skin in poor condition (ulcerations or wounds), acute febrile processes, acute thrombophlebitis, pregnancy, phobia of electricity.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Gutmotion

    Santa Maria del Camí, Balearic, 07320

Other trials in Spain

About this study

Official title: Effectiveness of NESA in the Treatment of Sleep Problems, Fatigue, and Neuromuscular Pain in Cancer Survivors.

Cancer is a disease, or a set of diseases, that increased in our society. However, improvements in their detection and treatment increase the number of patients who survive. Every year 2.6 million people are diagnosed in the European Union and 1.4 million become cancer survivors. However, these people suffer the late adverse effects of treatment that can seriously affect their quality of life.

the most common late effects are pain, fatigue, and sleeping difficulties. These are estimated between 58-90%. The autonomic nervous system (ANS) appears to play an important role in the manifestation and perpetuation of these symptoms.

Read the detailed description

This study aims to evaluate NESA (or NESA non-invasive neuromodulation) to treat the most common long-term side effects in cancer survivors, due to the most used treatments.

It will be compared between two groups of cancer survivors. The intervention group, with electrical stimulation, and the sham group, without electrical stimulation emission. The subjects will be assigned randomly. Neither the patient, the therapist, nor the analysts/researchers will know the assignment.

Finally, this project aims to add a passive tool to the therapeutic arsenal of health professionals in the oncology field for the treatment of late side effects.

Being tested
Non-invasive Neuromodulation, Placebo Non-invasive Neuromodulation
Keywords
cancer, physical therapy modality, Electric Stimulation Therapy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-invasive NeuromodulationDevice

    Patients receive non-invasive neurostimulation through the Nesa device

  • Placebo Non-invasive NeuromodulationDevice

    The same protocol described for the experimental group will be applied, but electrical stimulation device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.

Study groups in NCT06230679
Study groupRoleWhat they receive
Non-invasive NeuromodulationExperimentalIntervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Receives: Device: Non-invasive Neuromodulation
Placebo Non-invasive NeuromodulationPlacebo comparatorIntervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Receives: Device: Placebo Non-invasive Neuromodulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)

    The investigators want to see if there are improvements in the quality, efficiency, and quantity of sleep. The Pittsburgh Sleep Quality Index (PSQI) will be combined to report changes in the patient's sleep quality.

    Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

    Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep

    Measured: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 1 months of treatment (follow-up period).

  2. Change in quality of life assessed by The Short Form 36 (SF-36) health questionnaire

    The Short Form 36 (SF-36) health questionnaire will be used. It is a generic scale that provides a profile of health status and is applicable to both patients and the general population.

    It is composed of 36 questions (items) that assess both positive and negative states of health. The scores for each of the 8 dimensions of the SF-36 range from 0 to 100, with 100 indicating optimal health and 0 reflecting very poor health.

    Measured: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 1 months of treatment (follow-up period).

  3. Change in Pain assessed by McGill Pain questionnaire

    It is a self-report questionnaire that allows to give a good description of the quality and intensity of the pain they are experiencing. of the quality and intensity of the pain they are experiencing. It consists of a list of 78 words in 20 sections related to pain. Users mark the words that best describe their pain. users mark the words that best describe their pain. These words correlate with different aspects of pain different aspects of pain, including a sensory section (sections 1 to 10), an affective section (sections 11 to 15), an evaluative section (sections 11 to 15), and a 10), an affective section (sections 11 to 15), an evaluative section (section 16), and finally a miscellaneous section (section 16). and, finally, a miscellaneous section (sections 17 to 20).

    The main component of the McGill Pain questionnaire consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe

    Measured: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 1 months of treatment (follow-up period).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start19 Jan 2024
  3. Primary completion19 Sep 2025
  4. Study completion19 Dec 2025

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06230679
Sponsor's protocol ID
NESABiel
Status last verified
Aug 2025
First submitted
19 Jan 2024
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rick O, Dauelsberg T, Kalusche-Bontemps EM. Oncological Rehabilitation. Oncol Res Treat. 2017;40(12):772-777. doi: 10.1159/000481709. Epub 2017 Nov 29.

    PubMed 29183040

  • Paltrinieri S, Fugazzaro S, Bertozzi L, Bassi MC, Pellegrini M, Vicentini M, Mazzini E, Costi S. Return to work in European Cancer survivors: a systematic review. Support Care Cancer. 2018 Sep;26(9):2983-2994. doi: 10.1007/s00520-018-4270-6. Epub 2018 May 29.

    PubMed 29845421

  • Boland EG, Ahmedzai SH. Persistent pain in cancer survivors. Curr Opin Support Palliat Care. 2017 Sep;11(3):181-190. doi: 10.1097/SPC.0000000000000292.

    PubMed 28700361

  • Kline-Quiroz C, Nori P, Stubblefield MD. Cancer Rehabilitation: Acute and Chronic Issues, Nerve Injury, Radiation Sequelae, Surgical and Chemo-Related, Part 1. Med Clin North Am. 2020 Mar;104(2):239-250. doi: 10.1016/j.mcna.2019.10.004. Epub 2019 Nov 23.

    PubMed 32035566

Questions about this trial

What is this clinical trial studying?

A study testing Non-invasive Neuromodulation in people with Cancer Survivors, run by Aníbal Báez Suárez at 1 site in Spain.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Jan 2026. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) (time frame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 1 months of treatment (follow-up period).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06230679, which also lists 4 linked publications.

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 16 Jan 2026.

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