Chemotherapy-induced Nausea and VomitingNCT03405324
Effect of tDCS of the Motor Cortex on Chemotherapy Induced Nausia and Vomiting
A study testing tDCS in people with Chemotherapy-induced Nausea and Vomiting, run by Shereen Mamdouh at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- breast cancer therapy receiving anthracyclin based adjuvant chemotherapy and prophylaxis against nausea and vomiting
Who cannot join
- patients with intracranial metallic devices or with pacemakers or any other device.
- patients with extensive myocardial ischemia
- patients known to have epilepsy patients refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients
this work is looking for the effect of tDCS of the motor cortex on the chemotherapy induced nausea and vomiting in cancer breast patients
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- tDCS, sham tDCS
- Keywords
- brain stimulation, tDCS, nausea and vomiting
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
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 tDCSDevice
sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the first 72 hours after the infusion of chemotherapy
Secondary outcomes (1)
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
Measured: the first 72 hours after the infusion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jan 2018
- Primary completion1 Feb 2019
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shereen Mamdouh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405324
- Sponsor's protocol ID
- 233
- Status last verified
- Jun 2019
- First submitted
- 15 Jan 2018
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34677609
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03405324
- Acronym / sponsor ID
- 233
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- brain stimulation, tDCS, nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shereen MamdouhUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Device: tDCSa 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 . |
| sham tDCS | Sham comparator | Device: sham tDCSa 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 . |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- breast cancer therapy receiving anthracyclin based adjuvant chemotherapy and prophylaxis against nausea and vomiting
Key exclusion criteria (3 listed)
- patients with intracranial metallic devices or with pacemakers or any other device.
- patients with extensive myocardial ischemia
- patients known to have epilepsy patients refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSa 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. | Device | active tDCS |
| sham tDCSsham tDCS | Device | sham tDCS |
Primary outcome
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
1 secondary outcome
cumalative vomiting scoring
Time frame: the first 72 hours after the infusion of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Derived from this study: PubMed 34677609Kamal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Chemotherapy-induced Nausea and Vomiting, run by Shereen Mamdouh at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative of nausea scoring (time frame: the first 72 hours after the infusion of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.