The Effectiveness of Electroacupuncture With Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain

Study Overview
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Brief Summary
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Gynecological cancer is cancer that starts in the female reproductive organs. Pain in gynecological cancer can be caused by an underlying malignancy or surgical procedure as well as chronic pain associated with malignancy and sequelae of the therapy given. Gynecological cancer patients often experience moderate to severe pain and use higher levels of opioids than patients diagnosed with other cancers. More than two thirds of patients with advanced cancer experience severe pain and up to half of these patients report that their pain is not well controlled. This study aims to analyze the effectiveness of electroacupuncture plus standard therapy on pain intensity (VAS score), changes in analgesic dose, and quality of life (QLQ C-30 EORTC score) in patients with gynecological cancer pain compared to standard therapy alone.

Detailed Description
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This study was conducted using single blinded randomized control clinical trial, design in 58 patients diagnosed with gynecological cancer, aged 18 to 65 years, who experienced cancer pain, with VAS ≥ 4, pain caused by a tumor, before or while undergoing a therapeutic process (radiation therapy, chemotherapy, or post surgery), side effects or due to the toxicity of cancer treatment, willing to take part in this study and sign informed consent who were randomized into 2 groups, namely group I electroacupuncture with standard therapy and group 2 standard therapy, the acupuncture points used were LI4, PC6, ST36, SP6 and LR3, after the acupuncture needle was inserted, the needle was connected to the electrosimulator. The outputs assessed were pain intensity using the VAS, changes in analgesic dose, and quality of life with the EORTC QLQ C-30 questionnaire, which was assessed on the day before starting therapy, the first day, the second day, the third day, the fifth day and the seventh day.

Official Title
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The Effectiveness of Electroacupuncture With Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain

Conditions
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Gynecologic Cancer, Cancer Related Pain, Cancer Pain

Intervention / Treatment
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* Other: Electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 to 65 years old Gynecocal cancer with pain ≥ 4 acording Visual Analog scale and receive analgetic medicine The pain cause by direct from cancer Treatment proces surgery, radiotherapy, chemotherapy, paliatif treatment, supportive treatment Adverse reaction form treatment and intoxication Exclusion Criteria: Emergency case patient with hemodynamic instable Patient with uncooperative behavior because ith serious psychological disorders, no currently undergoing psychiatric treatment, aggressive behavior, that not allowed for acupuncture. Patients with blood clotting disorders, with platelets <50.000 and in neutropenic condition with <1000 neutrophils. The patient has an allergy to stainless steel acupuncture needles. Wounds at the acupuncture point puncture sites, skin infections in the ears. On patients with eczema on the ears, external otitis or psoriasis. There is a tumor in the area that will be stabbed and stimulated in the stomach pregnant women, close to the heart, or in the area of the carotid sinus lymphedema, insertion into the prosthesis. Patients with heart rhythm disorders. The patient uses a pace maker.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The Patient are cancer patient that experience cancer pain that only receive analgetic drug treatment according to WHO Stepledder of Pain | |
| Experimental: Electroacupuncture and standard Therapy<br>The Patient are cancer patient that experience cancer paint that receive analgetic drug treatement according WHO stepledder of pain and receive electroacupuncture | Other: Electroacupuncture<br>* Patient receive analgetic medicine will get experimental procedure with needle insertion that attach to eletrostimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity with Visual Analog Scale | Rating scale for measuring pain, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes. | Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organisation for Research and Treatment of Cancer Quality of Life C30 | A Quesionaire for measuring quality of Life | before treatment and 7 day after treatment | 
| Analgetic Usage in dosage and frequency | by assessing drug dose reductions and frequency before and after | Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroacupuncture, Cancer pain, Gynecological cancer pain, Acupuncture, VAS, EORTC QLQ C 30, Quality of Life, Analgetic Dose