Clinical trial NCT06115330: The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain
Official title: The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy Compared With Standard Therapy in Gynecological Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologycal Cancer
Cancer Related Pain
Cancer Pain
Keywords: Battlefield acupuncture
Ear acupuncture
Cancer pain
Gynecologycal cancer pain
Quality of life
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study was conducted using a single blinded randomized control clinical trial design in 58 female patients who are hospitalized aged 18-65 years, have a diagnosis of gynecological cancer, with a VAS score≥4 caused by tumor, before or during a therapeutic process (radiation therapy, chemotherapy, or after surgery), agree to participate in the study, sign the informed consent form who were randomized into 2 groups, namely group I BFA ear acupuncture with standard therapy and group 2 standard therapy, the acupuncture points used were placed at points MA-IT1 Cingulate Gyrus, MA-AT2 Thalamus, MA-H2 Omega 2, MA-H1 Point Zero, MA-TF1 Shenmen on both sides of the ear using Pyonex needles were placed with a diameter of 0.17mm, depth of 0.9mm. the pyonex press needle. were retained for three days The outcome 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain Severity with Visual Analog Scale
timeFrame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Secondary outcomes:
measure: Quality of Life with European Organisation for Research and Treatment of Cancer Quality of Life C30
timeFrame: before treatment and 7 day after treatment
measure: Analgetic Usage
timeFrame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Fatmawati Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Persahabatan Hospital
state: DKI Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: