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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06073496

Collaborator

(none)

Enrollment

Locations

Arms

3.1

Anticipated Duration (Months)

19.3

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer Cancer Related Pain Cancer Pain	Other: Electroacupuncture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

asessor

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 30, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain severity with Visual Analog Scale [Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430
2	Fatmawati Hospital	Jakarta	DKI Jakarta	Indonesia	12430
3	Persahabatan Hospital	Jakarta	DKI Jakarta	Indonesia	13230