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Trial Title:
Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer
NCT ID:
NCT06200168
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:
The acupuncturists will insert needles into the acupoints and manipulate the needles
until"de qi"sensation is achieved and reported by the participants. Electrical
stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz.
Arm group label:
True acupuncture + standard quadruple antiemetic therapy
Intervention type:
Drug
Intervention name:
Standard antiemetic treatment
Description:
Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous
(IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron
8 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant
combined with palonosetron or ondansetron, can also be taken orally in a fixed
combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30
minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post
chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.
Arm group label:
True acupuncture + standard quadruple antiemetic therapy
Intervention type:
Device
Intervention name:
Sham electroacupuncture
Description:
The sham acupuncture comprised a core standardized prescription of minimally invasive,
shallow needle insertion using thin and short needles at body locations not recognized as
true acupuncture points and are deemed to not belong to traditional Chinese meridians and
have no therapeutic value. Participants will receive minimal acupuncture treatment
without electrical stimulation at the same time as the intervention group.Care was taken
to avoid "de qi" sensation.
Arm group label:
Sham acupuncture + standard quadruple antiemetic therapy
Intervention type:
Drug
Intervention name:
Standard antiemetic treatment
Description:
Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous
(IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron
8 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant
combined with palonosetron or ondansetron, can also be taken orally in a fixed
combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30
minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post
chemotherapy. Dexamethasone doses may be individualized based on the doctor's
judgment.All the antiemetic drugs used are the same as those in the true acupuncture
group.
Arm group label:
Sham acupuncture + standard quadruple antiemetic therapy
Summary:
This randomized controlled phase III trial aims to evaluate the use of electroacupuncture
in combination with olanzapine-containing standard quadruple antiemetic drugs for the
treatment of nausea and vomiting induced by highly emetogenic chemotherapy (HEC) in
patients with breast cancer. Furthermore, it will analyze the relationship between single
nucleotide polymorphism and electroacupuncture treatment for chemotherapy-induced nausea
and vomiting.
Detailed description:
This study is a parallel-group, blinded (participants, evaluators, and statisticians),
randomized controlled trial exploring the effectiveness of electroacupuncture combined
with standard quadruple antiemetic drugs for breast cancer patients undergoing HEC. Both
groups will receive Olanzapine, Neurokinin-1 receptor antagonists (NK-1RAs), serotonin
receptor antagonists [5HT3RA], and dexamethasone at the start of HEC on Day 1.
Electroacupuncture or sham acupuncture will be randomly administered to each group.
Participants will document all instances of nausea and vomiting and note the use of
rescue antiemetic medications. Blood samples will be collected and analyzed to
investigate whether genetic polymorphisms can predict electroacupuncture outcomes in
breast cancer patients undergoing HEC. Primary and secondary outcomes as well as adverse
events will be assessed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18 years or older and aged 75 years or younger, of any nationality;
2. Eastern Cooperative Oncology Group performance status of 0-2;
3. Patients with breast cancer, with no restrictions on molecular typing; early-stage
patients must not have undergone prior chemotherapy, while advanced-stage patients
must be candidates for first-line chemotherapy and have declined neoadjuvant or
adjuvant chemotherapy for over 3 months. All patients must receive highly emetogenic
chemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC or
AC) or carboplatin (AUC≥4)/cisplatin;
4. Predicted life expectancy of ≥3 months;
5. Adequate bone marrow, kidney, and liver function;
6. Adequate contraception if premenopausal women;
7. Written informed consent by the patient before enrolment.
Exclusion Criteria:
1. Patients already submitted to chemotherapy;
2. Is scheduled to receive any non-HEC on Day 1;
3. Is scheduled to receive any chemotherapy on days 2-4 after HEC;
4. Received or is scheduled to receive radiation therapy to the abdomen, pelvis, head
and neck within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1;
5. Has symptomatic primary or metastatic symptomatic central nervous system malignancy
causing nausea and/or vomiting;
6. Have ongoing emesis or CTCAE grade 2 or greater nausea;
7. Significant medical or mental conditions;
8. Any allergies to study drug, antiemetics or dexamethasone;
9. Significantly abnormal laboratory values (platelets, coagulation indexes, absolute
neutrophils, AST, ALT, bilirubin or creatinine);
10. Patients who are pregnant or breast-feeding;
11. Inflammatory skin reaction;
12. Has lymphedema in acupuncture stimulation area;
13. Patients who are afraid of electroacupuncture stimulation or allergic to stainless
steel needles;
14. Received acupuncture treatments for any conditions less than 4 weeks before HEC;
15. Currently using drugs with antiemetic activity (e.g., 5-HT3 receptor antagonists,
corticosteroids (except when used at physiological doses), dopamine receptor
antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for
nocturnal sedation));
16. Patients with concomitant severe diseases or with a predisposition to emesis such as
gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic
brain metastasis;
17. Has a convulsive disorder requiring anticonvulsant treatment;
18. Patients administered thioridazine as a chronic antipsychotic medication (patients
are allowed to receive prochlorperazine and other phenothiazines as a rescue
antiemetic treatment);
19. Concurrent treatment with quinolone antibiotics;
20. Has a history of chronic alcoholism (determined by the investigator);
21. Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial
infarction within the past six months;
22. Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic
agents).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Qinghai University Affiliated Hospital
Address:
City:
Xining
Zip:
810000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiuda Zhao, Dr
Phone:
869716230893
Email:
jiudazhao@126.com
Start date:
December 20, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Jiuda Zhao
Agency class:
Other
Source:
Affiliated Hospital of Qinghai University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06200168
