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

NCT03405324 | Unknown

• 1 other identifier: 233
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

brain stimulation, tDCS, nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• Cumulative of nausea scoring

  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 Outcomes (1)

• cumalative vomiting scoring

  the first 72 hours after the infusion of chemotherapy

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

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

sham tDCS

SHAM COMPARATOR

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

Interventions

tDCS 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.

active tDCS

sham tDCS DEVICE

sham tDCS

sham tDCS

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• patients with intracranial metallic devices or with pacemakers or any other device.
• patients with extensive myocardial ischemia
• patients known to have epilepsy patients refusal.

Sponsors & Collaborators

• Shereen Mamdouh: lead

Study Sites (1)

South Egypt Cancer Institute

Asyut, 11715, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34677609 DERIVED

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU and pain relief

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: January 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: September 1, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

EG (1)