Clinical trial NCT06073496: The Effectiveness of Electroacupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Official title: The Effectiveness of Electroacupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Cancer Related Pain
Cancer Pain
Keywords: Electroacupuncture
Cancer pain
Gynecological cancer pain
Acupuncture
VAS
EORTC QLQ C 30
Quality of Life
Analgetic Dose
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

  1. direct from cancer
  2. Treatment proces surgery, radiotherapy, chemotherapy, paliatif treatment, supportive treatment
  3. 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.

Primary outcomes:
measure: Pain severity with Visual Analog Scale
timeFrame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Secondary outcomes:
measure: European Organisation for Research and Treatment of Cancer Quality of Life C30
timeFrame: before treatment and 7 day after treatment
measure: Analgetic Usage in dosage and frequency
timeFrame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Fatmawati Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Persahabatan Hospital
state: DKI Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: