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Evaluation of the efficiency of a device for cramps resulting from oncological treatments

Evaluation of the efficiency of an ionic load reduction device for Cramps arising from Chemotherapy-induced Peripheral Neuropathy (CIPN) and/or treatments inducing muscle ion overload and abrupt pH changes: a double-blind, randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-377gqvx
Enrollment
Unknown
Registered
2024-04-08
Start date
2023-01-22
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

Cramp and spasm

Interventions

The present study involves a clinical trial with 2 arms, employing double-blind blinding. Sixty patients will be randomly selected and assigned to form two groups, each comprising 30 individuals. The
C10.597.613.500

Sponsors

Associação de Combate ao Câncer de Goiás - ACCG
Lead Sponsor
Associação de Combate ao Câncer de Goiás - ACCG
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both genders; with Chemotherapy-Induced Peripheral Neuropathy (CIPN); and/or treatments causing an excess of ions in the muscles and abrupt changes in pH

Exclusion criteria

Exclusion criteria: Cramps related to the sciatic nerve; or a previous history of cramps; or weak and intermittent cramps

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: Evaluate reduction of cramps in patients affected by chemotherapy-induced peripheral neuropathy, using Magicramp® technology, which is an electrostatic charge-reducing cushion ;Expected Encontrado 1: Improved pain and cramps caused by Chemotherapy-Induced Peripheral Neuropathy (CIPN), using Magicramp® technology, which is an electrostatic charge-reducing cushion

Secondary

MeasureTime frame
Expected Outcome 2: We investigated the type of pain associated with cramps induced by chemotherapy drugs, aiming to distinguish it from various other causative sources and to elucidate mechanisms similar and dissimilar to this symptom, which has been classified as a disease by ICD-10 with codes 67.2 (cramps due to heat) and 25.2. This was done to enable the physician to differentiate the diagnosis and find the most specific solution possible. However, we did not obtain clear results because the medical records presented a variety of medications. Additionally, each participant cited many types of pain in the McGill questionnaire, and due to the small sample size with various interventions, we did not have an adequate numerical basis to establish correlations;Outcome found 2: We did not obtain clear results regarding pain/medication distinction, due to Hospital Araujo Jorge being filled with medication innovations, with many clinical trials using new drugs, and medical records presenting a high variety of new oncology medications. It was not possible to establish causal relationships. Additionally, each participant mentioned multiple types of pain from the extensive MCGILL questionnaire used, and therefore, the 29 patients with various different interventions did not provide us with an adequate numerical basis to correlate types of pain with their specific medications

Countries

Brazil

Contacts

Public ContactGeraldo Queiroz

Associação de Combate ao Câncer de Goiás - ACCG

gqueiz@yahoo.com.br+55-62- 32437000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)