Effectiveness of NESA in the Treatment of Cancer Survivors

A

Aníbal Báez Suárez

Status

Enrolling

Conditions

Cancer Survivors

Treatments

Device: Non-invasive Neuromodulation
Device: Placebo Non-invasive Neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06230679
NESABiel

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Non-invasive Neuromodulation
Experimental group
Description:
Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Treatment:
Device: Non-invasive Neuromodulation
Placebo Non-invasive Neuromodulation
Placebo Comparator group
Description:
Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Treatment:
Device: Placebo Non-invasive Neuromodulation

Trial contacts and locations

1

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Central trial contact

Gabriel Amengual Jaume, MSc

Data sourced from clinicaltrials.gov

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