Effectiveness of NESA in the Treatment of Cancer Survivors

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

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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