Back to resultsThe Effectiveness of Electroacupuncture With Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Primary Purpose
Gynecologic Cancer, Cancer Related Pain, Cancer Pain
Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
About this trial
This is an interventional supportive care trial for Gynecologic Cancer focused on measuring Electroacupuncture, Cancer pain, Gynecological cancer pain, Acupuncture, VAS, EORTC QLQ C 30, Quality of Life, Analgetic Dose
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Cipto Mangunkusumo HospitalRecruiting
- Fatmawati HospitalRecruiting
- Persahabatan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Electroacupuncture and standard Therapy
Arm Description
The Patient are cancer patient that experience cancer pain that only receive analgetic drug treatment according to WHO Stepledder of Pain
The Patient are cancer patient that experience cancer paint that receive analgetic drug treatement according WHO stepledder of pain and receive electroacupuncture
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
European Organisation for Research and Treatment of Cancer Quality of Life C30
A Quesionaire for measuring quality of Life
Analgetic Usage in dosage and frequency
by assessing drug dose reductions and frequency before and after
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06073496
Brief Title
The Effectiveness of Electroacupuncture With Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Official Title
The Effectiveness of Electroacupuncture With Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This study was conducted using single blinded randomized control clinical trial, design in 58 patients diagnosed with gynecological cancer, aged 18 to 65 years, who experienced cancer pain, with VAS ≥ 4, pain caused by a tumor, before or while undergoing a therapeutic process (radiation therapy, chemotherapy, or post surgery), side effects or due to the toxicity of cancer treatment, willing to take part in this study and sign informed consent who were randomized into 2 groups, namely group I electroacupuncture with standard therapy and group 2 standard therapy, the acupuncture points used were LI4, PC6, ST36, SP6 and LR3, after the acupuncture needle was inserted, the needle was connected to the electrosimulator. The outputs 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
asessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Patient are cancer patient that experience cancer pain that only receive analgetic drug treatment according to WHO Stepledder of Pain
Arm Title
Electroacupuncture and standard Therapy
Arm Type
Experimental
Arm Description
The Patient are cancer patient that experience cancer paint that receive analgetic drug treatement according WHO stepledder of pain and receive electroacupuncture
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Intervention Description
Patient receive analgetic medicine will get experimental procedure with needle insertion that attach to eletrostimulator
Primary Outcome Measure Information:
Title
Pain severity with Visual Analog Scale
Description
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.
Time Frame
Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Secondary Outcome Measure Information:
Title
European Organisation for Research and Treatment of Cancer Quality of Life C30
Description
A Quesionaire for measuring quality of Life
Time Frame
before treatment and 7 day after treatment
Title
Analgetic Usage in dosage and frequency
Description
by assessing drug dose reductions and frequency before and after
Time Frame
Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female with gynecology cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zulaika Rosalin
Phone
+628129720146
Email
zulaika.rosalin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KEPK FKUI-RSCM
Organizational Affiliation
The Ethics Committee of the Faculty of Medicine, University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
Phone
1 500 135
Facility Name
Fatmawati Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
12430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
Phone
(021) 7501524
Facility Name
Persahabatan Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
13230
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
Phone
(021) 4891708
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Electroacupuncture With Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
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