- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06115330
The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain
The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy Compared With Standard Therapy in Gynecological Cancer Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alvita Ratnasari
- Phone Number: +6282256108070
- Email: alvitaratnasari@gmail.com
Study Locations
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-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 13230
- Persahabatan Hospital
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Jakarta, DKI Jakarta, Indonesia, 12430
- Fatmawati Hospital
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ear Acupuncture with Standard Medical Therapy
The intervention group was give a press needle acupuncture with standard medical therapy for gynecological cancer pain
|
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
|
No Intervention: Standard Medical Therapy
The control group was given standard medical therapy for gynecological cancer pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Severity with Visual Analog Scale
Time Frame: 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. 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life with European Organisation for Research and Treatment of Cancer Quality of Life C30
Time Frame: before treatment and 7 day after treatment
|
European Organisation for Research and Treatment of Cancer Quality of Life C30, that include two item of review functional scale and the global health scale both scale the higher the score the outcome will be better
|
before treatment and 7 day after treatment
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Analgetic Usage
Time Frame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
|
Analgetic used during the treatment measured in miligram
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Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: KEPK FKUI-RSCM, The Ethics Committee of the Faculty of Medicine, University of Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-06-0971
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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