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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06073496
• Other study ID #: 23-06-0970
• Status: Completed
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: January 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Cancer Related Pain
• Gynecologic Cancer

Intervention

Other:
• Electroacupuncture
Patient receive analgetic medicine will get experimental procedure with needle insertion that attach to eletrostimulator

Locations

Country	Name	City	State
Indonesia	Fatmawati Hospital	Jakarta	DKI Jakarta
Indonesia	Persahabatan Hospital	Jakarta	DKI Jakarta
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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