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

NCT06768359 | Completed

• 1 other identifier: 24-12-1826
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 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?

Conditions

Anxiety; Quality of Life; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score

  6 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

The manual acupuncture and standard therapy

Procedure: Manual acupuncture and standard therapy

Control Group

SHAM COMPARATOR

The sham acupuncture and standard therapy

Procedure: Sham acupuncture and standard therapy

Interventions

Manual acupuncture and standard therapy PROCEDURE

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.

Intervention Group

Sham acupuncture and standard therapy PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

RS Kanker Dharmais

Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants, and outcome assessors will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: The manual acupuncture and standard therapy will be designed as the intervention group, while the sham acupuncture and standard therapy will be designed as the control group

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 10, 2025
• Study Start: March 24, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)