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CompletedNCT06768359Updated Jan 8, 2026

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

An interventional study of Manual acupuncture and standard therapy and Sham acupuncture and standard therapy in Anxiety, Quality of Life and Cancer, sponsored by Indonesia University. Completed at 2 sites in Indonesia. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety
  • Quality of Life
  • Cancer
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 38 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Intervention Group

    The manual acupuncture and standard therapy

    Procedure: Manual acupuncture and standard therapy

  • Sham comparator
    Control Group

    The sham acupuncture and standard therapy

    Procedure: Sham acupuncture and standard therapy

Interventions

  • ProcedureManual 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.

  • ProcedureSham 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.

06

What researchers measure

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.

    Time frame: 6 days

Secondary outcomes

  1. 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

    Time frame: 6 days

07

Study locations

2 sites
  • Universitas Indonesia
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
  • RS Kanker Dharmais
    Jakarta, 11420, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06768359
Lead sponsor
Indonesia University
Responsible party
Deity Indrayati Nugraha (Medical doctor, Indonesia University) — Principal investigator
First posted
Jan 10, 2025
Start date
Mar 24, 2025
Primary completion
Nov 15, 2025
Completion
Nov 30, 2025
Last update
Jan 8, 2026

Study contacts

KEPK FKUI-RSCM
principal investigator · The Health Research Ethics Commitee of Faculty of Medicine
KEPK RS Kanker Dharmais
principal investigator · The Health Research Ethics Commitee of Dharmais Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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