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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03405324
Enrollment
30
Registered
2018-01-23
Start date
2018-01-01
Completion date
2019-09-30
Last updated
2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

brain stimulation, tDCS, nausea and vomiting

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.

Interventions

DEVICEtDCS

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.

DEVICEsham tDCS

sham tDCS

Sponsors

Shereen Mamdouh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cumulative of nausea scoringthe first 72 hours after the infusion of chemotherapy0=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

Secondary

MeasureTime frameDescription
cumalative vomiting scoringthe first 72 hours after the infusion of chemotherapy0= None 1=1 episode in 24h 2= 2-5 episodes in 24h 3=More 6 episodes in 24h 4=Life threatening consequence

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026