The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain

NCT06115330 | Completed DMC

• 1 other identifier: 23-06-0971
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

Pain is one of the most important symptoms of cancer patients, with nearly 40% of all cancer patients experiencing moderate to severe pain. Gynecological oncology patients on palliative care have a chief complaint of pain or significant nausea/vomiting, contrary to the patient's initial complaints on admission such as fever, infection, dyspnea, changes, altered consciousness, bleeding, pancytopenia. Strong recommendations by WHO regarding the use of non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol and opioids either alone or in combination in adults, including the elderly and adolescents with cancer-related pain in the early stages, pain relief depending on clinical judgment and severity to achieve pain treatment which is fast and safe. Ear acupuncture is a simple and safe method that can be used alone or in combination with other forms of medical care, which is effective in treating a variety of conditions as well as painful conditions. Based on the previous 2020 systematic review regarding ear acupuncture in its benefits in cancer pain, it was stated that ear acupuncture was effective in treating pain in cancer patients with moderate pain levels, effective for reducing pain scores, faster onset, and longer duration of analgesics. Ear acupuncture is also more effective when compared to standard therapy without acupuncture, so it can be used as an additional modality for cancer pain. Currently there is no research on the effectiveness of BFA ear acupuncture therapy in the treatment of gynecological cancer pain to treat it based on the consistency of point selection, so it is necessary to conduct research on the effectiveness of BFA ear acupuncture therapy in the treatment of gynecological cancer pain. This study aim to analyze the effectiveness of BFA ear acupuncture therapy plus standard therapy on pain intensity (VAS score), changes in analgesic dose, and quality of life (EORTC QLQ C-30 score) in patients with gynecological cancer pain compared to standard therapy alone.

Conditions

Gynecologycal Cancer; Cancer Related Pain; Cancer Pain

Keywords

Battlefield acupuncture; Ear acupuncture; Cancer pain; Gynecologycal cancer pain; Quality of life

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. assessment used to assess intensity of certain sensations and feelings, like pain.

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

Secondary Outcomes (2)

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

  before treatment and 7 day after treatment

• Analgetic Usage

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

Study Arms (2)

Ear Acupuncture with Standard Medical Therapy

EXPERIMENTAL

The intervention group was give a press needle acupuncture with standard medical therapy for gynecological cancer pain

Device: Press Needle Acupuncture

Standard Medical Therapy

NO INTERVENTION

The control group was given standard medical therapy for gynecological cancer pain

Interventions

Press Needle Acupuncture DEVICE

Ear acupuncture using Pyonex press needles were installed with a diameter of 0.17mm, 0.9mm deep. The needles were retained for three days and stimulated at the installation site of the patch needle by means of pressure on the acupuncture point ears that have been attached needles on both sides, 1 minute at each point, four times a day, for 3 consecutive days and the patch was removed on the 3rd day

Ear Acupuncture with Standard Medical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with gynecological cancer.
• Women over 18 years to 65 years
• Subjects experiencing pain in cancer, with VAS ≥4, namely pain that caused by
• tumors,
• before or during a therapeutic process (radiation therapy, chemotherapy or postoperatively).
• side effect or the result of toxicity of cancer treatment.
• Willing to participate in this research and sign informed consent

You may not qualify if:

• The patient has a medical emergency / hemodynamically unstable.
• Uncooperative patients, with serious psychological disorders, no currently undergoing psychiatric treatment, aggressive behavior, no allow for acupuncture.
• Patients with blood clotting disorders, with platelets \<50.000114 and in neutropenic condition with \<1000 neutrophils. 114
• 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

Condition Hierarchy (Ancestors)

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

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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: November 3, 2023
• Study Start: August 30, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)