- ICH GCP
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- Essai clinique NCT07644533
Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Advanced Cancer
Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Advanced Cancer: A Randomized Controlled Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jiuda Zhao
- Numéro de téléphone: 869716162732
- E-mail: jiudazhao@126.com
Sauvegarde des contacts de l'étude
- Nom: Fuxing Zhao
- Numéro de téléphone: 18797349621
- E-mail: 18797349621@163.com
Lieux d'étude
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Qinghai
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Xining, Qinghai, Chine, 810000
- Qinghai University Affiliated Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age ≥ 18 years.
- Pathological and imaging examinations confirmed the diagnosis of advanced cancer(IV stage), including: breast cancer, gastric cancer, intestinal cancer, non-small cell lung cancer or ovarian cancer;
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Scheduled to receive chemotherapy containing a taxane, utidelone, or oxaliplatin, with no significant pre-existing neurological symptoms prior to chemotherapy. Specific regimens include: Colorectal cancer: Oxaliplatin-containing regimen. Gastric cancer: Oxaliplatin-containing or taxane-containing regimen. Breast cancer: Taxane-containing or utidelone-containing regimen. NSCLC or Ovarian cancer: Taxane-containing regimen.
- No history of acupuncture treatment within one month prior to study initiation.
- Adequate major organ function, meeting the following laboratory criteria: Hematology: Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; White blood cell count 3.5 - 9.5 × 10^9/L; Hemoglobin ≥ 100 g/L. Hepatic Function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase and alanine aminotransferase ≤ 3 × ULN; Serum bilirubin concentration < 1.5 mg/dL; Serum albumin > 2.5 g/dL. Renal Function: Serum creatinine ≤ 1.5 × ULN, OR calculated creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula). Coagulation: International normalized ratio ≤ 1.5, AND activated partial thromboplastin time ≤ 1.5 × ULN.
- Willing to receive acupuncture intervention and undergo subsequent follow-up assessments.
- Voluntarily agree to participate in the study and sign an informed consent form.
Exclusion Criteria:
- Patients with early-stage cancer.
- Pre-existing peripheral neuropathy prior to the initiation of chemotherapy.
- Severe impairment of major organ function, rendering the patient unable to tolerate standard-dose chemotherapy.
- Presence of active skin infection or other conditions unsuitable for acupuncture treatment.
- Coexisting underlying diseases associated with peripheral neuropathy, such as diabetes mellitus, Guillain-Barré syndrome, or chronic inflammatory demyelinating polyradiculoneuropathy.
- Current use of medications for neuropathic pain (e.g., gabapentin, pregabalin).
- Pregnant or lactating patients.
- Presence of dermatological conditions, as assessed by the clinician, that may interfere with the study procedures or outcomes.
- Patients with active brain metastases.
- Patients with a history of implanted cardiac pacemakers or defibrillators, or a history of epilepsy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: True electroacupuncture combined with true thumbtack needle group
Electroacupuncture will be administered on days 1, 2 and 3 of chemotherapy, followed by thumbtack needle therapy on days 4, 5, and 6 of chemotherapy, and no intervention will be given at other times.
For electroacupuncture, we will choose the following acupoints: Zusanli, Hegu, Taichong, Quchi, and Yanglingquan.
After achieving 'deqi', electrodes will be connected bilaterally as follows: Quchi to Yanglingquan, and Hegu to Zusanli.
Stimulation will be delivered at 2/10Hz with a current of ≤10mA for 30 minutes.
For thumbtack needle therapy, bilateral Zusanli, Hegu, and Taichong points will be sterilized with 75% alcohol before inserting and embedding the thumbtack needles.
On the day of thumbtack needle therapy, patients will be instructed to press each thumbtack for one minute at 9:00, 13:00, and 17:00, to induce a mild sensation of soreness and fullness.
The electroacupuncture and thumbtack needle therapy will be given for each chemotherapy cycle.
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The acupoints Zusanli, Hegu, Taichong, Quchi, and Yanglingquan will be selected for treatment.
After inserting the needle with a 'deqi', electrodes will be connected bilaterally as follows: Quchi to Yanglingquan, and Hegu to Zusanli.
The electroacupuncture parameters adopt a sparse wave type, with a frequency of 2/10Hz and a current intensity not exceeding 10mA.
The treatment time is 30 minutes, based on the patient's tolerance.
The Zusanli, Hegu, and Taichong on both sides will be selected for thumbtack needle therapy, clean the skin with a 75% alcohol cotton swab, and quickly insert the thumbtack needle into the skin and into the selected acupoints.
On the day of thumbtack needle therapy, patients will be instructed to press each thumbtack for one minute at 9:00, 13:00, and 17:00, to induce a mild sensation of soreness and fullness.
If fainting or skin allergies occur during the thumbtack needle therapy, the thumbtack needle will be promptly removed.
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Comparateur factice: Sham electroacupuncture combined with sham thumbtack needle group
Sham electroacupuncture will be administered on days 1, 2, and 3 of chemotherapy, followed by sham thumbtack needle therapy on days 4, 5, and 6 of chemotherapy, and no intervention will be given at other times.
Sham electroacupuncture operation: Select the same acupoints as the experimental group, select 1-2cm near the Zusanli, Hegu, Taichong, Quchi, and Yanglingquan acupoints, shallow subcutaneous puncture, no electricity, 30 minutes.
Sham thumbtack needle operation: Select 1-2cm near the Zusanli, Hegu, and Taichong acupoints on both sides to apply fake snap needles(remove the needle tip) without pressing.
The same sham electroacupuncture and sham thumbtack needle therapy will be given for each chemotherapy cycle.
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Select Zusanli, Hegu, Taichong, Quchi, and Yanglingquan on both sides will be selected for sham electroacupuncture therapy, select 1-2cm near the Zusanli, Hegu, Taichong, Quchi, and Yanglingquan acupoints, shallow subcutaneous puncture, no electricity, 30 minutes.
Select Zusanli, Hegu, and Taichong on both sides will be selected for sham thumbtack needle therapy.
Select 1-2cm near the Zusanli, Hegu, and Taichong acupoints on both sides and apply sham thumbtack needle (remove the needle tip) without pressing.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The incidence of CIPN during chemotherapy (from the beginning of chemotherapy to the end of chemotherapy for any reason) .
Délai: 1 year
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The number of cases of CIPN occurring during chemotherapy/Total number of cases
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The incidence of CIPN at 3, 6, 9, and 12 months after the start of chemotherapy
Délai: 1 year
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Number of CIPN cases at 3, 6, 9, and 12 months after the start of chemotherapy/Total number of cases
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1 year
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The incidence of ≥ grade 3 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy
Délai: 1 year
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Number of cases of ≥ grade 3 sensory CIPN occurring at 3, 6, 9, and 12 months after the start of chemotherapy/Total number of cases
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1 year
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The incidence of ≥ grade 2 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy
Délai: 1 year
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Number of cases of ≥ grade 2 sensory CIPN occurring at 3, 6, 9, and 12 months after the start of chemotherapy/Total number of cases
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1 year
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The time of occurrence of all levels and levels 3 and above CIPN
Délai: 1 year
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The time of occurrence of all levels and levels 3 and above CIPN
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1 year
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EORTC-CIPN20 evaluation score
Délai: 1 year
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The scale consists of 20 questions, each divided into 4 levels: 1 point: completely none, 2 points: a little, 3 points: quite a lot, 4 points: very much.
The total score is converted into a standard rating score (0-100 points) through linear conversion, and there is only one unit of score.
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1 year
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EQ-5D-5L evaluation score
Délai: 1 year
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For the Descriptive System(Health State Index): A single summary index value(often called a 'utility' score) is calculated by applying a country-specific or region-specific value set(or 'tariff') to the 5-digit health state code. These value sets, derived from general population studies, assign weights to each possible health state. The index typically ranges from values less than 0(where 0=dead, and states worse than dead have negative values) to 1(full health). There is no single global scoring formula; the appropriate national value set must be used. For the EQ VAS: The score is the self-reported number between 0 and 100, representing the respondent's perception of their overall health at that moment. It is reported as a raw score, and there is only one unit of score. |
1 year
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AHQU-2026002
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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