Clinical trial NCT06768359: The Effect of Manual Acupuncture and Standard Therapy on Anxiety and Quality of Life Scores in Cancer Patients
Official title: The Effect of Manual Acupuncture and Standard Therapy on Anxiety and Quality of Life Scores in Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Quality of Life
Cancer
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hamilton anxiety rating scale (HAM-A) score
timeFrame: 6 days
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score
timeFrame: 6 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: The Health Research Ethics Commitee of Faculty of Medicine
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: