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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Cancer Pain; Cancer Related Pain
• Intervention / Treatment: Other: Electroacupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zulaika Rosalin; Phone Number: +628129720146; Email: zulaika.rosalin@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 13230
      • Persahabatan Hospital
    • Jakarta, DKI Jakarta, Indonesia, 12430
      • Fatmawati Hospital
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; The Patient are cancer patient that experience cancer paint that receive analgetic drug treatement according WHO stepledder of pain and receive electroacupuncture	Other: Electroacupuncture; Patient receive analgetic medicine will get experimental procedure with needle insertion that attach to eletrostimulator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI-RSCM, The Ethics Committee of the Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Acupuncture; VAS; Cancer pain; Electroacupuncture; Gynecological cancer pain; EORTC QLQ C 30; Analgetic Dose
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: 23-06-0970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No