Status:
UNKNOWN
Personalized Electroacupuncture Treatment for Chemotherapy-induced Nausea and Vomiting in Breast Cancer (PET)
Lead Sponsor:
Affiliated Hospital of Qinghai University
Conditions:
Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
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 wi...
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 an...
Eligibility Criteria
Inclusion
- 18 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.
Exclusion
- 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;
- Patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy;
- Patients receiving concomitant steroids, except when administered at physiologic doses;
- Patients receiving concomitant benzodiazepines, except when used for nocturnal sedation.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT05275569
Start Date
March 15 2022
End Date
December 31 2024
Last Update
April 4 2022
Active Locations (1)
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1
Jiuda Zhao
Xining, Qinghai, China, 810000