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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
Sponsor:
Information provided by (Responsible Party):
Shereen Mamdouh, Assiut University

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

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Device: tDCS Device: sham tDCS Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405324


Contacts
Contact: Shereen M Kamal, Lecturer 01006279209 sheridouh79@yahoo.com
Contact: Hassan M Kotb, Professor kotbhi@yahoo.com

Locations
Egypt
South Egypt Cancer Institute Recruiting
Assiut, Egypt, 11715
Contact: Shereen M Kamal, Lecturer    01006279209    sheridouh79@yahoo.com   
Contact: Hassan M Kotb, Professor       kotbhi@yahoo.com   
Sponsors and Collaborators
Shereen Mamdouh

Responsible Party: Shereen Mamdouh, Lecturer of anesthesia, ICU and pain relief, Assiut University
ClinicalTrials.gov Identifier: NCT03405324     History of Changes
Other Study ID Numbers: 233
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shereen Mamdouh, Assiut University:
brain stimulation, tDCS, nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms