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

June 27, 2019 updated by: Shereen Mamdouh

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 11715
        • South Egypt Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 .
Device: 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.
Sham Comparator: 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 .
Device: sham tDCS
sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative of nausea scoring
Time Frame: the first 72 hours after the infusion of chemotherapy

0=None

  1. Loss of appetite eout alternation in eating habits
  2. Dec. oral intake eout significant wgt loss, dehydration or malnutrion
  3. Iv fluids, tube feeding, TPN
  4. Life threatening consequence
the first 72 hours after the infusion of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumalative vomiting scoring
Time Frame: the first 72 hours after the infusion of chemotherapy
0= None 1=1 episode in 24h 2= 2-5 episodes in 24h 3=More 6 episodes in 24h 4=Life threatening consequence
the first 72 hours after the infusion of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shereen Mamdouh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

February 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 233

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy-induced Nausea and Vomiting

Clinical Trials on tDCS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe