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Enrolling by invitation NCT07747194

Acupuncture to Prevent Nausea and Vomiting After Stem Cell Transplant

No phase Interventional Chemotherapy-Induced Nausea and Vomiting (CINV) Hematopoietic Stem Cell Transplantation (HSCT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupuncture, Conventional care.
Who it may be relevant to
Registry conditions: Chemotherapy-Induced Nausea and Vomiting (CINV), Hematopoietic Stem Cell Transplantation (HSCT). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Study and Mechanism Exploration of Acupuncture at Neiguan (PC6) for Preventing Nausea and Vomiting in Patients Undergoing Hematopoietic Stem Cell Transplantation

Overview

This study is testing whether acupuncture at a point on the wrist called "Neiguan" can help reduce nausea and vomiting in patients undergoing stem cell transplantation. Participants will receive either real acupuncture or standard care. We hope to find a safe way to improve comfort during cancer treatment.

Interventions

  • Procedure Acupuncture
    Add-on manual acupuncture at bilateral Neiguan (PC6) to standard quadruple anti-emetic prophylaxis. Disposable sterile acupuncture needles inserted perpendicularly 0.5-1 cun (approximately 10-25 mm) into Neiguan with even reinforcing-reducing manipulation; needles retained for 30 minutes. Administered once daily throughout the conditioning (preparative) regimen. This distinguishes the intervention from: (1) the active comparator arm in this study, which receives identical pharmacological prophy
  • Drug Conventional care
    Standard quadruple pharmacological anti-emetic prophylaxis comprising a 5-HT3 receptor antagonist, an NK-1 receptor antagonist, dexamethasone, and olanzapine, administered per institutional HSCT supportive care protocol. No acupuncture or sham procedure is provided. This distinguishes the arm from the experimental arm, which receives the identical pharmacological regimen plus add-on manual acupuncture at Neiguan (PC6).

Primary outcome measures

  • Incidence and severity of nausea and vomiting during the conditioning regimen for hematopoietic stem cell transplantation [Time frame: Throughout the conditioning period (approximately 3-7 days)]
Secondary outcome measures (1)
  • Nutritional status assessed by serum albumin and prealbumin levels [Time frame: Baseline (pre-conditioning), Day 7, Day14, and Day 28 of conditioning, and Day 30 post-transplant]

Eligibility criteria

Inclusion criteria

Age 18-65 years, either sex. Patients scheduled to receive a conditioning (preparative) regimen for hematopoietic stem cell transplantation (HSCT).

Life expectancy ≥ 3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment.

Voluntary participation with signed informed consent.

Exclusion criteria

Received chemotherapy with highly emetogenic agents within 14 days prior to enrollment.

Received radiotherapy within 7 days prior to enrollment, or planned radiotherapy during the study period.

Known hypersensitivity to any study drug or its excipients. Complicated with gastrointestinal obstruction, brain metastasis with symptoms of increased intracranial pressure, or any other condition that may cause and/or exacerbate nausea and vomiting.

Active infection. Unable to take oral medications. Use of any anti-emetic medication (including corticosteroids) within 48 hours or 5 half-lives of the drug (whichever is longer) prior to enrollment.

Any episode of nausea, vomiting, or retching within 24 hours prior to the first administration.

Severe psychiatric illness or cognitive impairment that precludes understanding, reading, and completing patient diaries.

Any other condition that the investigator deems would make the patient unsuitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • The General Hospital of Western Theater Command — Chengdu

Identifiers

NCT: NCT07747194 · PC6-HSCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗