Clinical trial NCT06230679: Effectiveness of NESA in the Treatment of Cancer Survivors
Official title: Effectiveness of NESA in the Treatment of Sleep Problems, Fatigue, and Neuromuscular Pain in Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivors
Keywords: cancer
physical therapy modality
Electric Stimulation Therapy
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 1 months of treatment (follow-up period).
measure: Change in quality of life assessed by The Short Form 36 (SF-36) health questionnaire
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 1 months of treatment (follow-up period).
measure: Change in Pain assessed by McGill Pain questionnaire
timeFrame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 1 months of treatment (follow-up period).
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria Del Camí
country: Spain
facility: Gutmotion
state: Balearic
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Gabriel Amengual Jaume, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.