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Clinical Trial NCT06314906 for Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer Phase 3 370

Recruiting
Clinical Trial NCT06314906 is designed to study Treatment for Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting. It is a Phase 3 interventional study that is recruiting, having started on 7 March 2024, with plans to enroll 370 participants. Led by Feixue Song, it is expected to complete by 31 March 2027. The latest data from ClinicalTrials.gov was last updated on 21 March 2024.
Brief Summary
This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy re...Show More
Detailed Description
This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.

Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC ...

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Official Title

Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study

Conditions
ElectroacupunctureOlanzapine-contained Four-drug AntiemeticNausea and Vomiting
Other Study IDs
  • SHLU-2024001
NCT ID Number
NCT06314906
Start Date (Actual)
2024-03-07
Last Update Posted
2024-03-21
Completion Date (Estimated)
2027-03-31
Enrollment (Estimated)
370
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
electroacupuncture
olanzapine-contained four-drug antiemetic
nausea and Vomiting
breast cancer
chemotherapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTrue Acupuncture Combined with Antiemetic Therapy
Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz.
Electroacupuncture
Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz
Antiemetic Therapy
Participants will receive oral olanzapine at a dose of 5 mg per day on days 1 through 4, along with NK1 receptor antagonist, 5HT3 receptor antagonist, and intravenous dexamethasone at a dose of 10 mg 30 minutes prior to chemotherapy on Day 1, followed by intravenous dexamethasone at a dose of 8 mg on days 2, 3, and 4 post-chemotherapy.
Placebo ComparatorAntiemetic therapy
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group. They will also receive the same antiemetic medications as the experimental group.
Sham electroacupuncture
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group
Antiemetic Therapy
They will also receive the same antiemetic medications as the experimental group.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Proportion of Patients Free from Nausea Throughout Treatment
The proportion of patients experiencing no nausea is determined by those who register a score of 0 on the visual-analogue scale for nausea throughout the entirety of treatment, spanning from initiation of chemotherapy to 120 hours post-treatment.
120 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. Patients aged 18 to 75 years, inclusive, from any nationality.
  2. Patients diagnosed with early-stage breast cancer.
  3. Eastern Cooperative Oncology Group performance status ranging from 0 to 2.
  4. All patients must undergo highly emetogenic chemotherapy (HEC).
  5. Adequate organ function.
  6. Adequate contraception required for premenopausal women.

  1. Scheduled to undergo chemotherapy between days 2 to 4 following HEC.
  2. Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1.
  3. Significant medical or psychological conditions.
  4. Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting.
  5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).
  6. Any known allergies to the study drug, antiemetics, or dexamethasone.
  7. Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.
  8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.
Feixue Song logoFeixue Song
Study Responsible Party
Feixue Song, Sponsor-Investigator, Professor, Lanzhou University Second Hospital
Study Central Contact
Contact: Feixue Song, Dr, 13639336037, [email protected]
1 Study Locations in 1 Countries

Gansu

Second Hospital of Lanzhou University, Lanzhou, Gansu, 730000, China
Feixue Song, Dr, Contact, 13639336037, [email protected]
Recruiting