Personalized Electroacupuncture Treatment for Chemotherapy-induced Nausea and Vomiting in Breast Cancer (PET)

NCT05275569 | Unknown

• 1 other identifier: AHQU-2022002
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate electroacupuncture as an antiemetic treatment compared with sham acupuncture in patients with breast cancer, receiving highly emetogenic chemotherapy (HEC). Moreover, it will analyze the association between single nucleotide polymorphism and the antiemetic outcomes of electroacupuncture.

Conditions

Cancer

Keywords

electroacupuncture treatment; chemotherapy-induced nausea; chemotherapy-induced vomiting; breast cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Significant Nausea, Rescue Treatment and Number of Times of Vomiting Occurs After chemotherapy (complete protection).

  The proportion of patients achieving complete protection is defined as patients who have no vomiting, no rescue treatment, no significant nausea that was assessed by visual analog scale (VAS, this is a Visual Analogue Scale was used to assess the incidence and intensity of nausea daily, a 100-mm horizontal bar containing no marking except for the anchor point at each end: left, no nausea; right, worst nausea. No nausea was defined as a VAS scores \< 5mm, no significant nausea was defined as a VAS scores \< 25mm), and maximum less than 25 mm during the first 120 hours after the initiation of chemotherapy (The definition is different from the complete response in the "Secondary endpoints" section).

  120 hours

Secondary Outcomes (13)

• The relationship between single nucleotide polymorphism genotypes and the proportion of patients with significant nausea, rescue treatment and number of times of vomiting occurs after chemotherapy (complete protection).

  120 hours

• The proportion of patients who have no vomiting/retching or rescue medications after chemotherapy during 0 to 24 hours (acute complete response)

  24 hours

• The proportion of patients who have no vomiting/retching or rescue medications after chemotherapy during 24 to 120 hours (delayed complete response)

  120 hours

• Number of times of no vomiting in the acute stage (0 to 24 hours) after chemotherapy (no vomiting in the acute stage)

  24 hours

• Number of times of no vomiting in the delayed stage (24 to 120 hours) after chemotherapy (no vomiting in the delayed stage)

  120 hours

Study Arms (2)

True acupuncture + standard antiemetic treatment

EXPERIMENTAL

Procedure: True acupuncture + standard antiemetic treatment

Sham acupuncture + standard antiemetic treatment

PLACEBO COMPARATOR

Procedure: Sham acupuncture + standard antiemetic treatment

Interventions

True acupuncture + standard antiemetic treatment PROCEDURE

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 fosaprepitant 150 mg intravenous IV + palonosetron 0.25 mg IV + dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy.

True acupuncture + standard antiemetic treatment

Sham acupuncture + standard antiemetic treatment PROCEDURE

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 fosaprepitant 150 mg intravenous IV + palonosetron 0.25 mg IV + dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post-chemotherapy(the antiemetic drugs are the same as the true acupuncture group).

Sham acupuncture + standard antiemetic treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, of any nationality;
• Eastern Cooperative Oncology Group performance status of 0-2;
• For patients with breast cancer, molecular typing is not limited, receiving for the first time chemotherapy with anthracyclines+ cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin -based HEC regimen. Patients with previous chemotherapy use could be enrolled if they received it \>3 months;
• 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;
• 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 mental conditions;
• Any allergies to study drug, antiemetics or dexamethasone;
• Significantly abnormal laboratory values (platelets, 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;
• The current use of any drugs with antiemetic activity (e.g. 5-HT3 RA, dopamine receptor antagonist, minor tranquilizer, antihistamine);
• Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, hypercalcemia and symptomatic brain metastasis;

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Jiuda Zhao

Xining, Qinghai, 810000, China

RECRUITING

Related Publications (1)

• Shen G, Ren D, Zhao F, Wang M, Liu Z, Feng X, He Y, Liu X, Ling X, Zhao Y, Song F, Ma J, Li E, She T, Liu Z, Li Z, Huang S, Chen Y, Yang J, Li X, Duan L, Da M, Zheng Y, Li Y, Zhao J. Effect of Adding Electroacupuncture to Standard Triple Antiemetic Therapy on Chemotherapy-Induced Nausea and Vomiting: A Randomized Controlled Clinical Trial. J Clin Oncol. 2024 Dec;42(34):4051-4059. doi: 10.1200/JCO.24.00099. Epub 2024 Sep 6.

  PMID: 39241208 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jiuda Zhao, MD

CONTACT

869716230893; jiudazhao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 11, 2022
• Study Start: March 15, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)