Effect of tDCS of the Motor Cortex on Chemotherapy Induced Nausia and Vomiting
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|ClinicalTrials.gov Identifier: NCT03405324|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Nausea and Vomiting||Device: tDCS Device: sham tDCS||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||April 2019|
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 .
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
- Cumulative of nausea scoring [ Time Frame: the first 72 hours after the infusion of chemotherapy ]
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405324
|Contact: Shereen M Kamal, Lectureremail@example.com|
|Contact: Hassan M Kotb, Professorfirstname.lastname@example.org|
|South Egypt Cancer Institute||Recruiting|
|Assiut, Egypt, 11715|
|Contact: Shereen M Kamal, Lecturer 01006279209 email@example.com|
|Contact: Hassan M Kotb, Professor firstname.lastname@example.org|