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

NCT06070363 | Completed DMC

• 1 other identifier: 23-06-1047
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Gynecologic Cancer; Cancer Related Pain; Cancer Pain; Acupuncture

Keywords

acupuncture; Manual Acupuncture; Cancer Pain; Cancer Related Pain; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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

  before treatment and 7 day after treatment

• Analgetic Usage in dosage and frequency

  Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7

Study Arms (2)

Control

NO INTERVENTION

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

Manual acupuncture and standard Therapy

EXPERIMENTAL

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

Other: Manual Acupuncture

Interventions

Manual Acupuncture OTHER

Acupuncture Needle Insertion

Manual acupuncture and standard Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female with gynecology cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (4)

Fatmawati Hospital

Jakarta, Dki Jakarta, 10430, Indonesia

Location

Persahabatan Hospital

Jakarta, Dki Jakarta, 13230, Indonesia

Location

Suryamin Hung

Jakarta, DKI Jakarta, 14250, Indonesia

Location

Cipto Mangunkusumo Hospital

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suryamin Suryamin

  Indonesia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator blind the participant allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: October 6, 2023
• Study Start: August 29, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)