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

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Quality of Life; Cancer

• Registration Number: NCT06768359
• Lead Sponsor: Indonesia University

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-23
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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 > 24)
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia