The Effect of Manual Acupuncture and Standard Therapy on Anxiety and Quality of Life Scores in Cancer Patients

The goal of this clinical trial is to prove that the combination of acupuncture therapy and standard therapy is more effective in reducing anxiety and improving the quality of life of cancer patients. The main questions it aims to answer are:

1. Can the combination of manual acupuncture and standard therapy reduce anxiety based on Hamilton Anxiety Rating Scale (HAM-A) scores in cancer patients compared to the sham acupuncture and standard therapy group?
2. Can the combination of manual acupuncture and standard therapy improve the quality of life of cancer patients based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) compared to the sham acupuncture and standard therapy group?

Participants will:

Get manual acupuncture therapy and also standard therapy, such as oral Benzodiazepin and supportive psychotherapy or sham acupuncture therapy and the standard therapy (Benzodiazepin and supportive psychotherapy) every day for 6 days.

Researchers will compare the changes of anxiety scores and quality of life between cancer patients who received manual acupuncture therapy and standard therapy, and cancer patients who received sham acupuncture and standard therapy.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cancer; Anxiety
• Intervention / Treatment: Procedure: Manual acupuncture and standard therapy; Procedure: Sham acupuncture and standard therapy

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 11420
    • RS Kanker Dharmais
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-59 years.
• Diagnosed with cancer in the last 6 months
• Experiencing moderate to severe anxiety (assessed by HAM-A Score > 14)
• Willing to participate in this study until completion and sign an informed consent.

Exclusion Criteria:

• Cancer patients with unstable hemodynamics
• Cancer patients with brain metastases
• Patients who have been diagnosed with anxiety disorders and have received pharmacological therapy from psychiatrists before.
• Patients who have contraindications to manual acupuncture (there are wounds or infections at the point to be punctured, patients are allergic to stainless steel, patients are phobic of needles)
• Patients who are uncooperative and do not allow acupuncture therapy (patients who are restless, angry)
• Patients with poor liver function (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (serum glutamate pyruvate transaminase)values increase 2-3 times the normal value)
• Patients with blood clotting disorders (platelets <50,000, INR (International Normalized Ratio) > 2)
• Patients with neutropenia (Absolute neutrophil count <1000)
• Patients with overt DIC (disseminated intravascular coagulation) and acute venous or arterial thrombosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The manual acupuncture and standard therapy	Procedure: Manual acupuncture and standard therapy; Manual acupuncture is acupuncture needle insertion was done perpendicularly to the acupuncture points GV20, EXHN3, HT7, and PC6 using Huanqiu needle measuring 0.25 x 25mm with mild stimulation rotation technique at a speed of 60x/minute and needle retention for 30 minutes. Therapy was performed every day for 6 days. Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient.
Sham Comparator: Control Group; The sham acupuncture and standard therapy	Procedure: Sham acupuncture and standard therapy; Sham acupuncture is when acupuncture needles are inserted into acupuncture points, but do not actually penetrate the skin, only attached to the plaster. Therapy was performed every day for 6 days. Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton anxiety rating scale (HAM-A) score	One tool to measure the degree of anxiety symptoms is a questionnaire. Scores range from 0-56.	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score	Questionnaire to assess the quality of life of cancer patients with anxiety. Scores range from 0-100	6 days

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI-RSCM, The Health Research Ethics Commitee of Faculty of Medicine; Principal Investigator: KEPK RS Kanker Dharmais, The Health Research Ethics Commitee of Dharmais Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Actual): November 15, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Anxiety Disorders; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 24-12-1826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No