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

NCT06073496 | Completed DMC

• 1 other identifier: 23-06-0970
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• European Organisation for Research and Treatment of Cancer Quality of Life C30

  before treatment and 7 day after treatment

• Analgetic Usage in dosage and frequency

  Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7

Study Arms (2)

Control

NO INTERVENTION

The Patient are cancer patient that experience cancer pain that only receive analgetic drug treatment according to WHO Stepledder of Pain

Electroacupuncture and standard Therapy

EXPERIMENTAL

The Patient are cancer patient that experience cancer paint that receive analgetic drug treatement according WHO stepledder of pain and receive electroacupuncture

Other: Electroacupuncture

Interventions

Electroacupuncture OTHER

Patient receive analgetic medicine will get experimental procedure with needle insertion that attach to eletrostimulator

Electroacupuncture and standard Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female with gynecology cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (3)

Fatmawati Hospital

Jakarta, DKI Jakarta, 12430, Indonesia

Location

Persahabatan Hospital

Jakarta, DKI Jakarta, 13230, Indonesia

Location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• KEPK FKUI-RSCM

  The Ethics Committee of the Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: asessor
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: August 30, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)