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

NCT ID: NCT05275569

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

True acupuncture + standard antiemetic treatment

Group Type: EXPERIMENTAL

True acupuncture + standard antiemetic treatment

Intervention Type: 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.

Sham acupuncture + standard antiemetic treatment

Group Type: PLACEBO_COMPARATOR

Sham acupuncture + standard antiemetic treatment

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Qinghai University

OTHER

Sponsor Role: lead

Responsible Party

Jiuda Zhao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiuda Zhao

Xining, Qinghai, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiuda Zhao, MD

Role: CONTACT

jiudazhao@126.com

869716230893

Facility Contacts

Jiuda Zhao

Role: primary

jiudazhao@126.com

869716230893

References

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.

Reference Type: DERIVED

PMID: 39241208 (View on PubMed)

Other Identifiers

AHQU-2022002

Identifier Type: -

Identifier Source: org_study_id