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

March 22, 2022 updated by: Jiuda Zhao, Affiliated Hospital of Qinghai University

Personalized Electroacupuncture Treatment Combined With Standard Antiemetic Drugs for Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer Receiving Highly Emetogenic Chemotherapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a parallel-group, triple-blinded (participants, evaluators and statisticians), randomized controlled study that investigates the antiemetic role of electroacupuncture combined with standard antiemetic drugs for patients with breast cancer receiving HEC. Neurokinin-1 receptor antagonists (NK-1RAs), serotonin receptor antagonists [5HT3RA] and dexamethasone will be administered prior to initiation of HEC on Day 1 in both groups. Electroacupuncture or sham acupuncture will be randomly administered to the two groups. Subjects will record all events of emesis and the use of rescue antiemetic medication for nausea and/or vomiting. Blood samples will be collected and be analyzed to whether genetic polymorphisms can be used to predict Electroacupuncture outcomes in patients with breast cancer receiving HEC. Primary and secondary outcomes and adverse events will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Recruiting
        • Jiuda Zhao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 18 years of age or older, of any nationality;
  2. Eastern Cooperative Oncology Group performance status of 0-2;
  3. 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;
  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. 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;
  4. Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
  5. Have ongoing emesis or CTCAE grade 2 or greater nausea;
  6. Significant mental conditions;
  7. Any allergies to study drug, antiemetics or dexamethasone;
  8. Significantly abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine);
  9. Patients who are pregnant or breast-feeding;
  10. Inflammatory skin reaction;
  11. Has lymphedema in acupuncture stimulation area;
  12. Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
  13. Received acupuncture treatments for any conditions less than 4 weeks before HEC;
  14. The current use of any drugs with antiemetic activity (e.g. 5-HT3 RA, dopamine receptor antagonist, minor tranquilizer, antihistamine);
  15. Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, hypercalcemia and symptomatic brain metastasis;
  16. Patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy;
  17. Patients receiving concomitant steroids, except when administered at physiologic doses;
  18. Patients receiving concomitant benzodiazepines, except when used for nocturnal sedation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: True acupuncture + standard antiemetic treatment
Procedure: True acupuncture + standard antiemetic treatment
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.
Placebo Comparator: Sham acupuncture + standard antiemetic treatment
Procedure: Sham acupuncture + standard antiemetic treatment
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Significant Nausea, Rescue Treatment and Number of Times of Vomiting Occurs After chemotherapy (complete protection).
Time Frame: 120 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 120 hours
The single nucleotide polymorphism genotypes will be analyzed by detecting different bases (A, T, C and G) in peripheral blood DNA. The proportion of patients with different single nucleotide polymorphism genotypes will be analyzed. 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 VAS as mentioned above, and maximum less than 25 mm during the first 120 hours after the initiation of chemotherapy. We will analyze the relationship between the proportion of patients with different single nucleotide polymorphism genotypes and the proportion of patients with 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)
Time Frame: 24 hours
The proportion of patients achieving acute complete response is defined as patients who have no vomiting/retching or rescue medications during 0 to 24 hours after the initiation of chemotherapy.
24 hours
The proportion of patients who have no vomiting/retching or rescue medications after chemotherapy during 24 to 120 hours (delayed complete response)
Time Frame: 120 hours
The proportion of patients achieving delayed complete response is defined as patients who have no vomiting/retching or rescue medications during delayed 24 to 120 hours after the initiation of chemotherapy.
120 hours
Number of times of no vomiting in the acute stage (0 to 24 hours) after chemotherapy (no vomiting in the acute stage)
Time Frame: 24 hours
The proportion of patients who have no vomiting during the acute stage (0 to 24 hours) after the initiation of chemotherapy.
24 hours
Number of times of no vomiting in the delayed stage (24 to 120 hours) after chemotherapy (no vomiting in the delayed stage)
Time Frame: 120 hours
The proportion of patients who have no vomiting during the delayed stage (24 to 120 hours) after the initiation of chemotherapy.
120 hours
Number of times of no vomiting in the overall stage (0 to 120 hours) after chemotherapy (no vomiting in the overall stage)
Time Frame: 120 hours
The proportion of patients who have no vomiting during 0 to 120 hours after the initiation of chemotherapy.
120 hours
The proportion of no nausea (no nausea in the overall stage)
Time Frame: 120 hours
The proportion of patients who have no nausea (VAS# 5 mm) that was assessed by VAS, and maximum less than 5 mm during the first 120 hours after the initiation of chemotherapy.
120 hours
The proportion of no significant nausea (no significant nausea in the overall stage)
Time Frame: 120 hours
The proportion of patients who have no significant nausea (VAS# 25 mm) that was assessed by VAS, and maximum less than 25 mm during the first 120 hours after the initiation of chemotherapy.
120 hours
The proportion of patients achieving total control (total control in the overall stage)
Time Frame: 120 hours
The proportion of patients achieving total control is defined as patients who have no vomiting, no rescue treatment, no nausea assessed by VAS, and maximum less than 5 mm during the first 120 hours after the initiation of chemotherapy.
120 hours
Constipation
Time Frame: 120 hours
The proportion of patients with constipation evaluated by Common Terminology Criteria for adverse events Version 4.0 during 0 to120 hours after the initiation of chemotherapy.
120 hours
Diarrhea
Time Frame: 120 hours
The proportion of patients with diarrhea evaluated by Common Terminology Criteria for adverse events Version 4.0 during 0 to120 hours after the initiation of chemotherapy.
120 hours
Fatigue
Time Frame: 120 hours
The proportion of patients with fatigue evaluated by Common Terminology Criteria for adverse events Version 4.0 during 0 to120 hours after the initiation of chemotherapy.
120 hours
Insomnia
Time Frame: 120 hours
The proportion of patients with insomnia evaluated by Common Terminology Criteria for adverse events Version 4.0 during 0 to120 hours after the initiation of chemotherapy.
120 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Hospital of Qinghai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHQU-2022002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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