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Effectiveness of Manual Acupuncture and 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
Manual Acupuncture
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer focused on measuring acupuncture, Manual Acupuncture, Cancer Pain, Cancer Related Pain, Gynecologic Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

  • Suryamin HungRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Manual acupuncture 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 manual acupuncture

Outcomes

Primary Outcome Measures

Pain severity with Visual Analog Scale
Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse pain A higher scale means worse outcomes

Secondary Outcome Measures

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
Analgetic Usage in dosage and frequency
Description of analagetic dosage and frequency during observation that will be describe as medicine category opioid non opioid, dosage and frequency

Full Information

First Posted
August 31, 2023
Last Updated
October 4, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT06070363
Brief Title
Effectiveness of Manual Acupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Official Title
Effectiveness of Manual Acupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
November 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
Cancer patients experience cancer pain as much as 66%. Cancer pain is pain that occurs in patients with neoplastic/malignancy and the source of the pain can come from malignant processes, treatments such as radiotherapy, chemotherapy, and surgery as well as other causes that are not related to malignancy processes. Unresolved pain can reduce the quality and life expectancy of cancer pain patients. The prevalence of cancer itself in Indonesia, the case of cervical cancer itself ranks second after breast cancer. In recent decades, acupuncture analgesics have been widely used to relieve cancer pain, and can also reduce the dose and side effects of analgesics. However, substantially the use of acupuncture in cancer pain is still very rare.
Detailed Description
The main outcome is to analyze the effectiveness of manual acupuncture therapy (LI4,PC6, LR3,ST36, and SP6 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. The patient will attempt 3-day manual acupuncture therapy with seven days follow up Patient will receive acupuncture therapy daily for 3 days, for 15 minute each day. The research design in this study was a single-blinded randomized control clinical trial. With outcome measures for With Subject criteria: Inclusion Criteria The patient is diagnosed with gynecological cancer Women over 18 years to 65 years Subjects experiencing cancer pain, with VAS ≥4, namely pain caused by: tumors, before or during a therapeutic process (radiation therapy, chemotherapy, or post-surgery) side effect or the result of toxicity of cancer treatment Supportive therapy (palliative therapy, painkillers, antidepressants) Willing to participate in this study and sign an informed consent Exclusion Criteria 1) The patient has a medical emergency / hemodynamically unstable 2) Patients with contraindications for manual acupuncture procedures such as wounds and infections at the point where the puncture will be performed, patients allergic to stainless steel62 3) Uncooperative patients (patients with negative and aggressive affect, who do not allow acupuncture therapy) 4) There is a tumor in the area that will be stabbed and stimulated in the pregnant woman's abdomen, close to the heart, or around the carotid sinus, lymphedema, needle insertion into the prosthesis 5) Patients with heart rhythm disorders 6) The patient uses a pacemaker 7) Patients with disorders of the auricle such as eczema, external otitis, and psoriasis 8) Patients with blood clotting disorders, with platelets <50,000, and in neutropenic conditions with neutrophils <1000

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, Acupuncture
Keywords
acupuncture, Manual Acupuncture, Cancer Pain, Cancer Related Pain, Gynecologic Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigator blind the participant allocation
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
Manual acupuncture 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 manual acupuncture
Intervention Type
Other
Intervention Name(s)
Manual Acupuncture
Intervention Description
Acupuncture Needle Insertion
Primary Outcome Measure Information:
Title
Pain severity with Visual Analog Scale
Description
Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse 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
Quality of Life with European Organisation for Research and Treatment of Cancer Quality of Life C30
Description
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
Time Frame
before treatment and 7 day after treatment
Title
Analgetic Usage in dosage and frequency
Description
Description of analagetic dosage and frequency during observation that will be describe as medicine category opioid non opioid, dosage and frequency
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
Suryamin Suryamin
Phone
82194624281
Ext
+62
Email
rem1que@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suryamin Suryamin
Phone
21315 7008
Ext
+62
Email
ec_fkui@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suryamin Suryamin
Organizational Affiliation
Indonesia University
Official's Role
Study Director
Facility Information:
Facility Name
Suryamin Hung
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
14250
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suryamin Suryamin, dr
Phone
82194624281
Ext
+62
Email
rem1que@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Manual Acupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain

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