- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jiuda Zhao
- Telefonní číslo: 869716162732
- E-mail: jiudazhao@126.com
Studijní záloha kontaktů
- Jméno: Fuxing Zhao
- Telefonní číslo: 18797349621
- E-mail: 18797349621@163.com
Studijní místa
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Qinghai
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Xining, Qinghai, Čína, 810000
- Qinghai University Affiliated Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Falešný srovnávač: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The incidence of CIPN during chemotherapy (from the beginning of chemotherapy to the end of chemotherapy for any reason) .
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The incidence of CIPN at 3, 6, 9, and 12 months after the start of chemotherapy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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