Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients

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

Sponsors

Lead sponsor: Shereen Mamdouh

Source Assiut University
Brief Summary

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

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.

Overall Status Active, not recruiting
Start Date January 1, 2018
Completion Date September 2019
Primary Completion Date February 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cumulative of nausea scoring the first 72 hours after the infusion of chemotherapy
Secondary Outcome
Measure Time Frame
cumalative vomiting scoring the first 72 hours after the infusion of chemotherapy
Enrollment 30
Condition
Intervention

Intervention type: Device

Intervention name: tDCS

Description: 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.

Arm group label: active tDCS

Intervention type: Device

Intervention name: sham tDCS

Description: sham tDCS

Arm group label: sham tDCS

Eligibility

Criteria:

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.

Gender: Female

Minimum age: 20 Years

Maximum age: 60 Years

Healthy volunteers: No

Location
facility
South Egypt Cancer Institute
Location Countries

Egypt

Verification Date

June 2019

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Assiut University

Investigator full name: Shereen Mamdouh

Investigator title: Lecturer of anesthesia, ICU and pain relief

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: active tDCS

Arm group type: Active Comparator

Description: 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 .

Arm group label: sham tDCS

Arm group type: Sham Comparator

Description: 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 .

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov