CancerNCT05275569
Personalized Electroacupuncture Treatment for Chemotherapy-induced Nausea and Vomiting in Breast Cancer (PET)
A study testing True acupuncture + standard antiemetic treatment in people with Cancer, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cancer
- What is being tested?
- True acupuncture + standard antiemetic treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiuda Zhao
Xining, Qinghai, 810000
Jiuda Zhao, 869716230893, jiudazhao@126.com
About this study
Official title: 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.
Read the 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
- Being tested
- True acupuncture + standard antiemetic treatment, Sham acupuncture + standard antiemetic treatment
- Keywords
- electroacupuncture treatment, chemotherapy-induced nausea, chemotherapy-induced vomiting, breast cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True acupuncture + standard antiemetic treatmentProcedure or surgery
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 treatmentProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| True acupuncture + standard antiemetic treatment | Experimental | Not described Receives: Procedure: True acupuncture + standard antiemetic treatment |
| Sham acupuncture + standard antiemetic treatment | Placebo comparator | Not described Receives: Procedure: Sham acupuncture + standard antiemetic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
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.
Measured: 120 hours
The proportion of patients who have no vomiting/retching or rescue medications after chemotherapy during 0 to 24 hours (acute complete response)
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.
Measured: 24 hours
The proportion of patients who have no vomiting/retching or rescue medications after chemotherapy during 24 to 120 hours (delayed complete response)
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.
Measured: 120 hours
Number of times of no vomiting in the acute stage (0 to 24 hours) after chemotherapy (no vomiting in the acute stage)
The proportion of patients who have no vomiting during the acute stage (0 to 24 hours) after the initiation of chemotherapy.
Measured: 24 hours
Number of times of no vomiting in the delayed stage (24 to 120 hours) after chemotherapy (no vomiting in the delayed stage)
The proportion of patients who have no vomiting during the delayed stage (24 to 120 hours) after the initiation of chemotherapy.
Measured: 120 hours
Number of times of no vomiting in the overall stage (0 to 120 hours) after chemotherapy (no vomiting in the overall stage)
The proportion of patients who have no vomiting during 0 to 120 hours after the initiation of chemotherapy.
Measured: 120 hours
The proportion of no nausea (no nausea in the overall stage)
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.
Measured: 120 hours
The proportion of no significant nausea (no significant nausea in the overall stage)
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.
Measured: 120 hours
The proportion of patients achieving total control (total control in the overall stage)
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.
Measured: 120 hours
Constipation
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.
Measured: 120 hours
Diarrhea
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.
Measured: 120 hours
Fatigue
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.
Measured: 120 hours
Insomnia
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.
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start15 Mar 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275569
- Sponsor's protocol ID
- AHQU-2022002
- Status last verified
- Mar 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39241208
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Electroacupuncture Treatment Combined With Standard Antiemetic Drugs for Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer Receiving Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT05275569
- Acronym / sponsor ID
- AHQU-2022002
- Conditions
- Cancer
- Keywords
- electroacupuncture treatment, chemotherapy-induced nausea, chemotherapy-induced vomiting, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True acupuncture + standard antiemetic treatmentParticipants 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. | Procedure or surgery | True acupuncture + standard antiemetic treatment |
| Sham acupuncture + standard antiemetic treatmentThe 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). | Procedure or surgery | Sham acupuncture + standard antiemetic treatment |
Primary outcome
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).
13 secondary outcomes
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 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 who have no vomiting/retching or rescue medications after chemotherapy during 24 to 120 hours (delayed complete response)
Time frame: 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
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
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 no nausea (no nausea in the overall stage)
Time frame: 120 hours
The proportion of no significant nausea (no significant nausea in the overall stage)
Time frame: 120 hours
The proportion of patients achieving total control (total control in the overall stage)
Time frame: 120 hours
Constipation
Time frame: 120 hours
Diarrhea
Time frame: 120 hours
Fatigue
Time frame: 120 hours
Insomnia
Time frame: 120 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 39241208Shen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True acupuncture + standard antiemetic treatment in people with Cancer, run by Affiliated Hospital of Qinghai University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiuda Zhao, MD (869716230893, jiudazhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Significant Nausea, Rescue Treatment and Number of Times of Vomiting Occurs After chemotherapy (complete protection). (time frame: 120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.