Clinical trial NCT06785623: Improvement of Depression in Terminal Cancer Patients
Official title: Improvement of Depression in Terminal Cancer Patients (IDTCP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Cancer Patients and Depression and Suicide
Life Quality
Keywords: depression
terminal cancer patients
palliative care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigates the potential of the water extract of Gastrodia elata Blume (WGE) to alleviate depressive symptoms in terminal cancer patients. In Taiwan, cancer accounts for 25-30% of annual deaths, with terminal patients often experiencing physical pain and psychological distress, including depression. Addressing both physical and psychological challenges is vital in palliative care.

Gastrodia elata Blume is a traditional dietary medicine known for its antidepressant, anti-inflammatory, antioxidant, neurotransmitter-regulating, and neuroprotective properties. This trial will recruit 60 hospice patients, randomly divided into two groups: a control group and a WGE experimental group.

Assessments will include:

1. General examinations (e.g., height, weight, blood pressure).
2. Non-invasive autonomic nervous system analyses.
3. Patient-reported measures: Quality of Life Scale (EORTC QLQ-C30), Pain Score, and Hospital Anxiety and Depression Scale (HADS).

The study hypothesizes that WGE can:

1. Alleviate depressive symptoms.
2. Enhance autonomic nervous system function.
3. Improve the quality of life for terminal cancer patients.

This research aims to demonstrate the therapeutic potential of WGE, improving psychological and physiological outcomes for hospice patients.

Detailed description: In Taiwan, the annual number of cancer-related deaths constitutes approximately 25-30% of the overall mortality rate. Terminal cancer patients often endure physical pain and psychological distress, leading to varying degrees of depression. Aligning with the objectives of palliative care, it is crucial to address both the physical pain and psychological well-being of patients. Gastrodia elata Blume (GE), a key component in traditional dietary medicine, has been extensively studied for its diverse biological activities, including antidepressant effects, anti-inflammatory properties, antioxidant capabilities, neurotransmitter regulation, and neuroprotection. This study aims to harness the antidepressant properties of GE to alleviate depression among hospice patients. The trial plans to recruit 60 subjects from the hospice ward, randomly assigning them to either a non-GE group or a GE experimental group (where subjects will consume water extract from 8 g of dried GE daily). Prior to and post each assessment, medical professionals will conduct general examinations (height, weight, blood pressure) and non-invasive autonomic nervous system analyses. Additionally, subjects will complete the Quality of Life Scale (EORTC QLQ-C30), Pain Score, and Hospital Anxiety and Depression Scale (HADS) to facilitate subsequent statistical analysis and evaluate the antidepressant efficacy of GE water extract. This experiment aims to demonstrate that GE water extract can improve depression in hospice patients, enhancing their autonomic nervous system function and overall quality of life.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years
* Diagnosis of terminal cancer, with an expected life expectancy of less than 6 months-
* Patients with sufficient cognitive status to respond to the research staff's evaluation questions

Exclusion Criteria:

* Patients or their families who refuse to participate
* Patients who withdraw from the study
* Patients who have participated in other research studies within one month before or during the trial
* Patients with suicidal tendencies

Primary outcomes:
measure: Reduction in Depressive Symptoms
timeFrame: 1 week
measure: Improvement in Quality of Life
timeFrame: 1 week
measure: Changes in Pain Score
timeFrame: 1 week
measure: Changes in heart rate variability
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Jaw Shiun Tsai
role: STUDY_CHAIR
References: