Clinical trial NCT06070363: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Cancer Related Pain
Cancer Pain
Acupuncture
Keywords: acupuncture
Manual Acupuncture
Cancer Pain
Cancer Related Pain
Gynecologic Cancer
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Pain severity with Visual Analog Scale
timeFrame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Secondary outcomes:
measure: Quality of Life with European Organisation for Research and Treatment of Cancer Quality of Life C30
timeFrame: before treatment and 7 day after treatment
measure: Analgetic Usage in dosage and frequency
timeFrame: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Dki Jakarta
city: Jakarta
country: Indonesia
facility: Fatmawati Hospital
state: Dki Jakarta
city: Jakarta
country: Indonesia
facility: Persahabatan Hospital
state: Dki Jakarta
city: Jakarta
country: Indonesia
facility: Suryamin Hung
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Suryamin Suryamin
role: STUDY_DIRECTOR
References: