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

University of Indonesia (UI)

Status: Completed

Conditions: Quality of Life; Cancer; Anxiety

Treatments: Procedure: Sham acupuncture and standard therapy; Procedure: Manual acupuncture and standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06768359

24-12-1826

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The manual acupuncture and standard therapy

Treatment:

Procedure: Manual acupuncture and standard therapy

Control Group

Sham Comparator group

Description:

The sham acupuncture and standard therapy

Treatment:

Procedure: Sham acupuncture and standard therapy