Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer

NCT06200168 | Recruiting Phase 3 DMC

• 1 other identifier: AHQU-2023002
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electroacupuncture; Olanzapine-contained Four-drug Antiemetic; Nausea and Vomiting

Keywords

electroacupuncture; olanzapine-contained four-drug antiemetic; nausea and Vomiting; breast cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with no nausea during the overall stage

  The proportion of patients achieving no nausea is defined as patients who have a response of 0 on the Visual Analog Scale for nausea during the overall stage (0 to 120 hours) after the initiation of chemotherapy.

  120 hours

Secondary Outcomes (13)

• Proportion of patients with no nausea during the early stage

  24 hours

• Proportion of patients with no nausea during the delayed stage

  96 hours

• The relationship between single nucleotide polymorphism genotypes and the proportion of patients with no nausea

  120 hours

• The proportion of patients achieving total control in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours).

  120 hours

• The proportion of patients achieving complete protection in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)

  120 hours

Study Arms (2)

True acupuncture + standard quadruple antiemetic therapy

EXPERIMENTAL

Participants will receive electroacupuncture once daily from day 1 to day 4. 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. They will receive 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 or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, 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.

Device: Electroacupuncture; Drug: Standard antiemetic treatment

Sham acupuncture + standard quadruple antiemetic therapy

PLACEBO COMPARATOR

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. They will receive olanzapine-contained four-drug antiemetic therapy. All the antiemetic drugs used are the same as those in the true acupuncture group.

Device: Sham electroacupuncture; Drug: Standard antiemetic treatment

Interventions

Electroacupuncture DEVICE

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.

True acupuncture + standard quadruple antiemetic therapy

Standard antiemetic treatment DRUG

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 or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, 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.

True acupuncture + standard quadruple antiemetic therapy

Sham electroacupuncture DEVICE

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.

Sham acupuncture + standard quadruple antiemetic therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older and aged 75 years or younger, of any nationality;
• Eastern Cooperative Oncology Group performance status of 0-2;
• 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;
• Predicted life expectancy of ≥3 months;
• Adequate bone marrow, kidney, and liver function;
• Adequate contraception if premenopausal women;
• Written informed consent by the patient before enrolment.

You may not qualify if:

• Patients already submitted to chemotherapy;
• Is scheduled to receive any non-HEC on Day 1;
• Is scheduled to receive any chemotherapy on days 2-4 after HEC;
• 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;
• Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
• Have ongoing emesis or CTCAE grade 2 or greater nausea;
• Significant medical or mental conditions;
• Any allergies to study drug, antiemetics or dexamethasone;
• Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine);
• Patients who are pregnant or breast-feeding;
• Inflammatory skin reaction;
• Has lymphedema in acupuncture stimulation area;
• Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
• Received acupuncture treatments for any conditions less than 4 weeks before HEC;
• 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));

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting; Breast Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Breast Disease Diagnosis and Treatment Center

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 10, 2024
• Study Start: January 16, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)