Effectiveness of NESA in the Treatment of Cancer Survivors

NCT06230679 | Completed

• 1 other identifier: NESABiel
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer Survivors

Keywords

cancer; physical therapy modality; Electric Stimulation Therapy

Outcome Measures

Primary Outcomes (3)

• 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

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

• 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.

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

• 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

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

Study Arms (2)

Non-invasive Neuromodulation

EXPERIMENTAL

Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

PLACEBO COMPARATOR

Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Device: Placebo Non-invasive Neuromodulation

Interventions

Placebo Non-invasive Neuromodulation DEVICE

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.

Placebo Non-invasive Neuromodulation

Non-invasive Neuromodulation DEVICE

Patients receive non-invasive neurostimulation through the Nesa device

Non-invasive Neuromodulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aníbal Báez Suárez: lead

Study Sites (1)

Gutmotion

Santa Maria del Camí, Balearic, 07320, Spain

Location

Related Publications (4)

• 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.

  PMID: 29183040 RESULT

• 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.

  PMID: 29845421 RESULT

• 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.

  PMID: 28700361 RESULT

• 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.

  PMID: 32035566 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Gabriel Amengual Jaume, MSc

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: January 19, 2024
• Primary Completion: September 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)