Gynecologycal CancerNCT06115330
The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain
A study testing Press Needle Acupuncture in people with Gynecologycal Cancer and Cancer Related Pain, run by Universitas Indonesia at 3 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Gynecologycal Cancer, Cancer Related Pain, Cancer Pain
- What is being tested?
- Press Needle Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesIndonesia
- Study dates
- 30 Aug 2023to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Fatmawati Hospital
Jakarta, DKI Jakarta, 12430
Persahabatan Hospital
Jakarta, DKI Jakarta, 13230
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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.
Read the 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
- Conditions
- Gynecologycal Cancer, Cancer Related Pain, Cancer Pain
- Being tested
- Press Needle Acupuncture
- Keywords
- Battlefield acupuncture, Ear acupuncture, Cancer pain, Gynecologycal cancer pain, Quality of life
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press Needle AcupunctureDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Ear Acupuncture with Standard Medical Therapy | Experimental | The intervention group was give a press needle acupuncture with standard medical therapy for gynecological cancer pain Receives: Device: Press Needle Acupuncture |
| Standard Medical Therapy | No intervention | The control group was given standard medical therapy for gynecological cancer pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: before treatment and 7 day after treatment
Analgetic Usage
Analgetic used during the treatment measured in miligram
Measured: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start30 Aug 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologycal CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvita Ratnasari, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115330
- Sponsor's protocol ID
- 23-06-0971
- Status last verified
- Feb 2024
- First submitted
- 29 Aug 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy Compared With Standard Therapy in Gynecological Cancer Pain
- ClinicalTrials.gov ID
- NCT06115330
- Acronym / sponsor ID
- 23-06-0971
- Conditions
- Gynecologycal Cancer, Cancer Related Pain, Cancer Pain
- Keywords
- Battlefield acupuncture, Ear acupuncture, Cancer pain, Gynecologycal cancer pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ear Acupuncture with Standard Medical Therapy | Experimental | Device: Press Needle AcupunctureThe intervention group was give a press needle acupuncture with standard medical therapy for gynecological cancer pain |
| Standard Medical Therapy | No intervention | –The control group was given standard medical therapy for gynecological cancer pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Willing to participate in this research and sign informed consent
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Press Needle AcupunctureEar 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 | Device | Ear Acupuncture with Standard Medical Therapy |
Primary outcome
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.
2 secondary outcomes
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
Analgetic Usage
Time frame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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First-line Carboplatin and Paclitaxel in Combination With Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient (pMMR) Endometrial Cancer
Endometrial Cancer, Recurrent Endometrial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KEPK FKUI-RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Press Needle Acupuncture in people with Gynecologycal Cancer and Cancer Related Pain, run by Universitas Indonesia at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity with Visual Analog Scale (time frame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.