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Trial Title:
Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
NCT ID:
NCT06314906
Condition:
Electroacupuncture
Olanzapine-contained Four-drug Antiemetic
Nausea and Vomiting
Conditions: Official terms:
Nausea
Vomiting
Antiemetics
Conditions: Keywords:
electroacupuncture
olanzapine-contained four-drug antiemetic
nausea and Vomiting
breast cancer
chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Electroacupuncture
Description:
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
Arm group label:
True Acupuncture Combined with Antiemetic Therapy
Intervention type:
Drug
Intervention name:
Antiemetic Therapy
Description:
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.
Arm group label:
True Acupuncture Combined with Antiemetic Therapy
Intervention type:
Device
Intervention name:
Sham electroacupuncture
Description:
Participants assigned to this arm will receive sham electroacupuncture sessions daily
from day 1 to day 4, mirroring the schedule of the experimental group
Arm group label:
Antiemetic therapy
Intervention type:
Drug
Intervention name:
Antiemetic Therapy
Description:
They will also receive the same antiemetic medications as the experimental group.
Arm group label:
Antiemetic therapy
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
regimens. By investigating the synergistic potential of these modalities, the study seeks
to provide insights into optimizing supportive care strategies for patients with breast
cancer undergoing intensive chemotherapy treatment.
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 on Day 1.
Subsequently, participants will be randomly assigned to receive either electroacupuncture
or sham acupuncture.
Participants will be responsible for recording all instances of nausea and vomiting, as
well as documenting the use of rescue antiemetic medications.
The study will evaluate primary and secondary outcomes, as well as monitor adverse
events.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Second Hospital of Lanzhou University
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Recruiting
Contact:
Last name:
Feixue Song, Dr
Phone:
13639336037
Email:
13639336037@139.com
Start date:
March 7, 2024
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Feixue Song
Agency class:
Other
Source:
Lanzhou University Second Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06314906
