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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tDCS
sham tDCS
Sponsored by
Shereen Mamdouh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring brain stimulation, tDCS, nausea and vomiting

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • South Egypt Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active tDCS

sham tDCS

Arm 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 .

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 .

Outcomes

Primary Outcome Measures

Cumulative of nausea scoring
0=None Loss of appetite eout alternation in eating habits Dec. oral intake eout significant wgt loss, dehydration or malnutrion Iv fluids, tube feeding, TPN Life threatening consequence

Secondary Outcome Measures

cumalative vomiting scoring
0= None 1=1 episode in 24h 2= 2-5 episodes in 24h 3=More 6 episodes in 24h 4=Life threatening consequence

Full Information

First Posted
January 15, 2018
Last Updated
June 27, 2019
Sponsor
Shereen Mamdouh
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1. Study Identification

Unique Protocol Identification Number
NCT03405324
Brief Title
Effect of tDCS of the Motor Cortex on Chemotherapy Induced Nausia and Vomiting
Official Title
Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shereen Mamdouh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
Keywords
brain stimulation, tDCS, nausea and vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm 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 Title
sham tDCS
Arm Type
Sham Comparator
Arm 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 .
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention 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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
sham tDCS
Primary Outcome Measure Information:
Title
Cumulative of nausea scoring
Description
0=None Loss of appetite eout alternation in eating habits Dec. oral intake eout significant wgt loss, dehydration or malnutrion Iv fluids, tube feeding, TPN Life threatening consequence
Time Frame
the first 72 hours after the infusion of chemotherapy
Secondary Outcome Measure Information:
Title
cumalative vomiting scoring
Description
0= None 1=1 episode in 24h 2= 2-5 episodes in 24h 3=More 6 episodes in 24h 4=Life threatening consequence
Time Frame
the first 72 hours after the infusion of chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assiut
ZIP/Postal Code
11715
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
34677609
Citation
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.
Results Reference
derived

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

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