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Effect of tDCS of the Motor Cortex on Chemotherapy Induced Nausia and Vomiting

NCT ID: NCT03405324

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-09-30

Brief Summary

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this work is looking for the effect of tDCS of the motor cortex on the chemotherapy induced nausea and vomiting in cancer breast patients

Detailed Description

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Chemotherapy has played an important role in improving patient outcomes in oncology and is a cornerstone of therapy for most patients with cancer. Of the adverse effects, none is more feared than chemotherapy-induced nausea and vomiting (CINV).

Nausea and vomiting can adversely affect patients' quality of life and make it difficult for them to perform their activities of daily living. Uncontrolled CINV can give rise to medical complications, including poor nutrition, dehydration, electrolyte imbalances, and physical and mental deterioration.The introduction and development of antiemetic drugs have significantly improved the ability of clinicians to control CINV. The mainstays of antiemetic therapy include serotonin (5-HT3) receptor antagonists (RAs) and neurokinin 1 (NK-1) RAs. Researchers and patients are seeking additional methods of controlling CINV, such as non-drug therapies. Transcranial direct current stimulation (tDCS) is a relatively simple technique requiring only a few parts.

Conditions

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Chemotherapy-induced Nausea and Vomiting

Keywords

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brain stimulation, tDCS, nausea and vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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active tDCS

a single session over the primary motor cortex with constant current of 2mA intensity was applied for 20 minutes with a 5-second ramp phase at the beginning applied to the participant patient before chemotherapy .

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

a single session of tDCS over the primary motor cortex with constant current of 2mA intensity will be applied for 20 minutes with a 5-second ramp phase at the beginning.

sham tDCS

a single session over the primary motor cortex with constant current of 2mA intensity was applied for 20 minutes with a 5-second ramp phase at the beginning applied to the participant patient before chemotherapy switched off after 30 second without the patient knowledge .

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

sham tDCS

Interventions

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tDCS

a single session of tDCS over the primary motor cortex with constant current of 2mA intensity will be applied for 20 minutes with a 5-second ramp phase at the beginning.

Intervention Type DEVICE

sham tDCS

sham tDCS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* breast cancer therapy receiving anthracyclin based adjuvant chemotherapy and prophylaxis against nausea and vomiting

Exclusion Criteria

* patients with intracranial metallic devices or with pacemakers or any other device.
* patients with extensive myocardial ischemia
* patients known to have epilepsy patients refusal.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shereen Mamdouh

OTHER

Sponsor Role lead

Responsible Party

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Shereen Mamdouh

Lecturer of anesthesia, ICU and pain relief

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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South Egypt Cancer Institute

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Kamal SM, Elhusseini NM, Sedik MF, Mohamad MF, Khedr EMH, Kotb HIM. Effect of Transcranial Direct Current Brain Stimulation of the Motor Cortex on Chemotherapy-Induced Nausea and Vomiting in Female Patients with Breast Cancer. Pain Med. 2022 Mar 2;23(3):571-578. doi: 10.1093/pm/pnab313.

Reference Type DERIVED
PMID: 34677609 (View on PubMed)

Other Identifiers

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233

Identifier Type: -

Identifier Source: org_study_id