Randomized controlled trial to evaluate the effect of neurologic modulation associated with conventional pain treatment versus conventional pain treatment in cancer patients with moderate to severe pain

Randomized, double-blind, controlled, phase 2, cross-sectional clinical trial over, of neuromodulation associated with classical analgesia versus classical placebo-associated analgesia in cancer patients with moderate to severe pain

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-10gm3crw

Enrollment

Unknown

Registered

2021-09-20

Start date

2019-10-02

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cronic pain intractable. malignant neoplasm localization unspecified

Interventions

Cellular neuromodulation therapy electromagnetic equipment (REAC technology), an application is made by a tissue nanoconductor in the shoulder and neck region or in the ear. 18-cycle therapy three ti

C23.888.592.612.212

Eligibility

Age

18 Years to 89 Years

Inclusion criteria

Inclusion criteria: patients with malignant neoplasia with moderate to severe pain; use of World Health OrganizationlLadder level 2 or 3 analgesics; cause of pain should be primarily cancer or its treatment; Age upper 18 years; Eastern Cooperative Oncology group performance status minus than 3; proper cognitive function to correctly complete the questionnaires; Availability for blood sample collection for evaluation of inflammatory parameters

Exclusion criteria

Exclusion criteria: Inability to attend treatment according to study design, as neuromodulation treatment cannot be delayed for more than 15 days between one session and another; Patients with fibromyalgia.

Design outcomes

Primary

Measure	Time frame
To assess pain perception change with at least 30% reduction in scale Analog Visual Pain in the neuromodulation intervention arm; ;Assess at least one level reduction in the depression, anxiety scale and stress 21 in the neuromodulation intervention arm;	—

Secondary

Measure	Time frame
Improvement of quality of life measured by the Eastern Cooperative Oncology group questionnaire in the neuromodulation intervention arm; ;Evaluate the tolerability and safety of neuromodulation associated with analgesia classical;;Evaluate the reduction in the amount of rescue medication used by the patient during the study in the neuromodulation intervention arm; ;;To evaluate the improvement of the degree of pain in the subgroup of patients with neuropathy in the neuromodulation intervention arm; ;Evaluate serum level of interleukins and its relation with the evolution of treatment in all subgroups ;	—

Measure

Time frame

Improvement of quality of life measured by the Eastern Cooperative Oncology group questionnaire in the neuromodulation intervention arm; ;Evaluate the tolerability and safety of neuromodulation associated with analgesia classical;;Evaluate the reduction in the amount of rescue medication used by the patient during the study in the neuromodulation intervention arm; ;;To evaluate the improvement of the degree of pain in the subgroup of patients with neuropathy in the neuromodulation intervention arm; ;Evaluate serum level of interleukins and its relation with the evolution of treatment in all subgroups ;

—

Countries

Brazil

Contacts

Public ContactAline Lima

CEPHO-Centro de Estudos e Pesquisa em Hematologia e Oncologia

aline.lima@oncologiador.com.br+5511969559700

Outcome results

None listed

Source: REBEC (via WHO ICTRP)