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

NCT ID: NCT06070363

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-29
• Study Completion Date: 2023-12-19

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

1. The patient is diagnosed with gynecological cancer

2. Women over 18 years to 65 years

3. 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)

4. 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

Conditions

Gynecologic Cancer; Cancer Related Pain; Cancer Pain; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

The Patient are cancer patient that experience cancer pain that only receive analgetic drug treatment according to WHO Stepledder of Pain

Group Type: NO_INTERVENTION

No interventions assigned to this group

Manual acupuncture and standard Therapy

The Patient are cancer patient that experience cancer paint that receive analgetic drug treatement according WHO stepledder of pain and receive manual acupuncture

Group Type: EXPERIMENTAL

Manual Acupuncture

Intervention Type: OTHER

Acupuncture Needle Insertion

Interventions

Manual Acupuncture

Acupuncture Needle Insertion

Intervention Type: OTHER

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

1. direct from cancer

2. Treatment proces surgery, radiotherapy, chemotherapy, paliatif treatment, supportive treatment

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Suryamin Suryamin

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suryamin Suryamin

Role: STUDY_DIRECTOR

Indonesia University

Locations

Fatmawati Hospital

Jakarta, Dki Jakarta, Indonesia

Persahabatan Hospital

Jakarta, Dki Jakarta, Indonesia

Suryamin Hung

Jakarta, DKI Jakarta, Indonesia

Cipto Mangunkusumo Hospital

Jakarta Pusat, Dki Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

23-06-1047

Identifier Type: -

Identifier Source: org_study_id