Standard Quadruple Antiemetic TherapyPhase 3NCT06952920
Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer
A Phase 3 study testing electroacupuncture and standard quadruple antiemetic therapy in people with Standard Quadruple Antiemetic Therapy and Electroacupuncture, run by Jiuda Zhao at 1 site in China.
Trial summary
This study aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Standard Quadruple Antiemetic Therapy, Electroacupuncture, Chemotherapy-induced Gastrointestinal Symptom Cluster
- What is being tested?
- electroacupuncture and standard quadruple antiemetic therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2025to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologically and pathologically confirmed stage I-III breast cancer;
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- Age between 18 and 75 years;
- Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy;
- No prior acupuncture treatment within one month before enrollment;
- Voluntary participation in the study with written informed consent obtained; (7) An expected survival of at least 3 months;
- Premenopausal women must agree to use contraception during the study period; (9) Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria.
Who cannot join
- Patients with advanced-stage cancer;
- Those undergoing concurrent chemoradiotherapy;
- Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy;
- Patients with contraindications to acupuncture, such as active skin infections;
- Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment;
- Patients with a history of xerostomia;
Show all 12Show fewer
- Individuals with known allergies to the study drugs;
- Pregnant or breastfeeding patients;
- Individuals currently using medications with antiemetic activity, such as 5-HT3 receptor antagonists, corticosteroids (except at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nighttime sedation);
- Patients with seizure disorders requiring anticonvulsant therapy;
- Those receiving thiazides as chronic antipsychotic medications;
- Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Jiuda Zhao，Dr, 869716230893, jiudazhao@126.com
About this study
Official title: Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer
This study aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of electroacupuncture on gastrointestinal symptoms. Ultimately, genomic studies will be performed to further clarify the key targets of electroacupuncture intervention, thereby providing high-level evidence-based medical support and theoretical foundations for optimizing electroacupuncture strategies in addressing chemotherapy-induced gastrointestinal symptoms in patients with cancer.
Read the detailed description
This prospective, multicenter, randomized, double-blind, sham-controlled trial investigates the efficacy of electroacupuncture (EA) combined with standard quadruple antiemetic therapy (olanzapine + dexamethasone + 5-HT3 receptor antagonist + NK-1 receptor antagonist) versus sham EA plus identical antiemetic regimen for chemotherapy-induced gastrointestinal symptom clusters (nausea, vomiting, poor appetite, and xerostomia ). The EA group receives true acupuncture with continuous wave stimulation (2Hz frequency, ≤10mA intensity as tolerated, 30min/session) administered: (1) 1-2h pre-chemotherapy on Day 1, and (2) daily at 9:00-10:00 from Days 2-4. Controls receive sham EA with an identical treatment schedule and the same antiemetics. Assessments during Days 1-5 include: Researchers record the incidence of nausea, vomiting, poor appetite, and xerostomia; Collection of weight, ECOG scores, and EQ-5D-5L questionnaires; documentation of antiemetic/chemotherapy use, concomitant medications, and adverse events; laboratory tests per cycle; and imaging when indicated. Blood samples are preserved every two cycles. Primary/secondary outcomes and adverse events are systematically evaluated.
- Conditions
- Standard Quadruple Antiemetic Therapy, Electroacupuncture, Chemotherapy-induced Gastrointestinal Symptom Cluster
- Being tested
- electroacupuncture, standard quadruple antiemetic therapy, sham electroacupuncture
- Keywords
- breast cancer, chemotherapy, standard quadruple antiemetic therapy, electroacupuncture, chemotherapy-induced gastrointestinal symptom cluster
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
The acupuncturist applied needles at four acupoints: Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6), with insertion depths of approximately 20 mm, 15 mm, 20 mm, and 5 mm respectively. Electrical stimulation was delivered in continuous wave mode at 2 Hz frequency with current intensity ≤10 mA (adjusted according to patient tolerance), administered for 30 minutes per session.
standard quadruple antiemetic therapyDrug
Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1).
sham electroacupunctureDevice
The same acupoints as the electroacupuncture group were referenced, but with sham acupuncture (minimal insertion at non-acupoint locations) and sham electrical stimulation, while maintaining the same treatment duration and course as the electroacupuncture group.
standard quadruple antiemetic therapyDrug
Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). All the antiemetic drugs used are the same as those in the true acupuncture group.
| Study group | Role | What they receive |
|---|---|---|
| true acupuncture + standard quadruple antiemetic therapy | Experimental | The experimental group received electroacupuncture (EA) combined with a standard quadruple antiemetic regimen comprising Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). EA was applied at Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6) with insertion depths of 20 mm, 15 mm, 20 mm, and 5 mm respectively, using continuous wave mode at 2 Hz and current intensity ≤10 mA (tolerance-adjusted) for 30 minutes per session. Treatment started 1-2 hours pre-chemotherapy on day 1 and continued daily at 9:00-10:00 on days 2-4, totaling four sessions per cycle. Receives: Device: electroacupuncture; Drug: standard quadruple antiemetic therapy |
| sham acupuncture + standard quadruple antiemetic therapy | Placebo comparator | The control group received sham electroacupuncture combined with the identical standard quadruple antiemetic regimen (drug components and dosages identical to the experimental group). The sham intervention protocol consisted of: (1) superficial needle insertion at non-acupoint locations adjacent to the authentic acupoints (ST36, PC6, LI4, and KI6); (2) attachment of non-functional electrodes using deactivated electroacupuncture devices with identical appearance to active units; while maintaining identical treatment duration (30 minutes/session) and schedule (pre-chemotherapy on day 1 followed by daily sessions on days 2-4) as the true electroacupuncture group. Receives: Device: sham electroacupuncture; Drug: standard quadruple antiemetic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy.
Measured: 120 hours
Secondary outcomes (6)
Improvement in other gastrointestinal symptom clusters after the first cycle of chemotherapy.
Measured: 120 hours
The incidence of no nausea during the acute and delayed phases following the first chemotherapy cycle.
Measured: 120 hours
The incidence of no vomiting during the overall, acute, and delayed phases following the first chemotherapy cycle.
Measured: 120 hours
Complete response rates in the overall, acute, and delayed phases following the first chemotherapy cycle.
Measured: 120 hours
Complete protection rates in the overall, acute, and delayed phases following the first chemotherapy cycle.
Measured: 120 hours
Quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L).
The EQ-5D-5L evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored from 1 ("no problems") to 5 ("extreme problems"), with health states expressed as 5-digit codes (e.g., 11111=no impairment; 55555=extreme impairment across all dimensions). Index scores were calculated using the Chinese value set (Luo et al., 2017), yielding a theoretical range of -0.391 (worse than death) to 1.0 (perfect health). The visual analogue scale (VAS) component records self-rated health status from 0 ("worst imaginable health") to 100 ("best imaginable health").
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 posted1 May 2025
- Study start21 Aug 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (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 Standard Quadruple Antiemetic TherapyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiuda Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952920
- Sponsor's protocol ID
- AHQU-2025002
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tao X, Liu Z, Wang M, Ren D, Zhao F, Wang H, Yang G, Zhang G, Li Z, Liu Z, Huang S, Chen Y, Da M, Ma X, Liang H, Li Y, Ye Y, Zheng Y, Liang X, Shen G, Bai X, Zhao J. Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer: Study Protocol for a Randomized Controlled Trial. Health Care Sci. 2026 Feb 17;5(1):85-94. doi: 10.1002/hcs2.70056. eCollection 2026 Feb.
PubMed 41767166
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06952920
- Acronym / sponsor ID
- AHQU-2025002
- Conditions
- Standard Quadruple Antiemetic Therapy, Electroacupuncture, Chemotherapy-induced Gastrointestinal Symptom Cluster
- Keywords
- breast cancer, chemotherapy, standard quadruple antiemetic therapy, electroacupuncture, chemotherapy-induced gastrointestinal symptom cluster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Jiuda ZhaoUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 May 2025 (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 elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of electroacupuncture on gastrointestinal symptoms. Ultimately, genomic studies will be performed to further clarify the key targets of electroacupuncture intervention, thereby providing high-level evidence-based medical support and theoretical foundations for optimizing electroacupuncture strategies in addressing chemotherapy-induced gastrointestinal symptoms in patients with cancer.
Detailed description
This prospective, multicenter, randomized, double-blind, sham-controlled trial investigates the efficacy of electroacupuncture (EA) combined with standard quadruple antiemetic therapy (olanzapine + dexamethasone + 5-HT3 receptor antagonist + NK-1 receptor antagonist) versus sham EA plus identical antiemetic regimen for chemotherapy-induced gastrointestinal symptom clusters (nausea, vomiting, poor appetite, and xerostomia ). The EA group receives true acupuncture with continuous wave stimulation (2Hz frequency, ≤10mA intensity as tolerated, 30min/session) administered: (1) 1-2h pre-chemotherapy on Day 1, and (2) daily at 9:00-10:00 from Days 2-4. Controls receive sham EA with an identical treatment schedule and the same antiemetics. Assessments during Days 1-5 include: Researchers record the incidence of nausea, vomiting, poor appetite, and xerostomia; Collection of weight, ECOG scores, and EQ-5D-5L questionnaires; documentation of antiemetic/chemotherapy use, concomitant medications, and adverse events; laboratory tests per cycle; and imaging when indicated. Blood samples are preserved every two cycles. Primary/secondary outcomes and adverse events are systematically evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| true acupuncture + standard quadruple antiemetic therapy | Experimental | Device: electroacupuncture, Drug: standard quadruple antiemetic therapyThe experimental group received electroacupuncture (EA) combined with a standard quadruple antiemetic regimen comprising Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). EA was applied at Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6) with insertion depths of 20 mm, 15 mm, 20 mm, and 5 mm respectively, using continuous wave mode at 2 Hz and current intensity ≤10 mA (tolerance-adjusted) for 30 minutes per session. Treatment started 1-2 hours pre-chemotherapy on day 1 and continued daily at 9:00-10:00 on days 2-4, totaling four sessions per cycle. |
| sham acupuncture + standard quadruple antiemetic therapy | Placebo comparator | Device: sham electroacupuncture, Drug: standard quadruple antiemetic therapyThe control group received sham electroacupuncture combined with the identical standard quadruple antiemetic regimen (drug components and dosages identical to the experimental group). The sham intervention protocol consisted of: (1) superficial needle insertion at non-acupoint locations adjacent to the authentic acupoints (ST36, PC6, LI4, and KI6); (2) attachment of non-functional electrodes using deactivated electroacupuncture devices with identical appearance to active units; while maintaining identical treatment duration (30 minutes/session) and schedule (pre-chemotherapy on day 1 followed by daily sessions on days 2-4) as the true electroacupuncture group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Radiologically and pathologically confirmed stage I-III breast cancer;
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- Age between 18 and 75 years;
- Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy;
- No prior acupuncture treatment within one month before enrollment;
Key exclusion criteria (12 listed)
- Patients with advanced-stage cancer;
- Those undergoing concurrent chemoradiotherapy;
- Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy;
- Patients with contraindications to acupuncture, such as active skin infections;
- Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment;
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 |
|---|---|---|
| electroacupunctureThe acupuncturist applied needles at four acupoints: Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6), with insertion depths of approximately 20 mm, 15 mm, 20 mm, and 5 mm respectively. Electrical stimulation was delivered in continuous wave mode at 2 Hz frequency with current intensity ≤10 mA (adjusted according to patient tolerance), administered for 30 minutes per session. | Device | true acupuncture + standard quadruple antiemetic therapy |
| standard quadruple antiemetic therapyOlanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). | Drug | true acupuncture + standard quadruple antiemetic therapy |
| sham electroacupunctureThe same acupoints as the electroacupuncture group were referenced, but with sham acupuncture (minimal insertion at non-acupoint locations) and sham electrical stimulation, while maintaining the same treatment duration and course as the electroacupuncture group. | Device | sham acupuncture + standard quadruple antiemetic therapy |
| standard quadruple antiemetic therapyOlanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). All the antiemetic drugs used are the same as those in the true acupuncture group. | Drug | sham acupuncture + standard quadruple antiemetic therapy |
Primary outcome
The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy.
Time frame: 120 hours
6 secondary outcomes
Improvement in other gastrointestinal symptom clusters after the first cycle of chemotherapy.
Time frame: 120 hours
The incidence of no nausea during the acute and delayed phases following the first chemotherapy cycle.
Time frame: 120 hours
The incidence of no vomiting during the overall, acute, and delayed phases following the first chemotherapy cycle.
Time frame: 120 hours
Complete response rates in the overall, acute, and delayed phases following the first chemotherapy cycle.
Time frame: 120 hours
Complete protection rates in the overall, acute, and delayed phases following the first chemotherapy cycle.
Time frame: 120 hours
Quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L).
Time frame: 120 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 41767166Tao X, Liu Z, Wang M, Ren D, Zhao F, Wang H, Yang G, Zhang G, Li Z, Liu Z, Huang S, Chen Y, Da M, Ma X, Liang H, Li Y, Ye Y, Zheng Y, Liang X, Shen G, Bai X, Zhao J. Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer: Study Protocol for a Randomized Controlled Trial. Health Care Sci. 2026 Feb 17;5(1):85-94. doi: 10.1002/hcs2.70056. eCollection 2026 Feb.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing electroacupuncture and standard quadruple antiemetic therapy in people with Standard Quadruple Antiemetic Therapy and Electroacupuncture, run by Jiuda Zhao 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 12 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy. (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 NCT06952920, 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 10 Jul 2026.