DepressionIDTCPNCT06785623
Improvement of Depression in Terminal Cancer Patients
A study testing Gastrodia elata Blume water extract in people with Depression and Cancer Patients and Depression and Suicide, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Depression, Cancer Patients and Depression and Suicide, Life Quality
- What is being tested?
- Gastrodia elata Blume water extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improvement of Depression in Terminal Cancer Patients (IDTCP)
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.
Read more
Assessments will include:
- General examinations (e.g., height, weight, blood pressure).
- Non-invasive autonomic nervous system analyses.
- 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:
- Alleviate depressive symptoms.
- Enhance autonomic nervous system function.
- 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.
Read the 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.
- Being tested
- Gastrodia elata Blume water extract
- Keywords
- depression, terminal cancer patients, palliative care
- Medical subject headings
- Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrodia elata Blume water extractDietary supplement
Subjects in the experimental group will consume Gastrodia elata Blume water extract daily. The extract is prepared from dried Gastrodia elata Blume, which is processed into a water-soluble form. This dosage is administered orally for a duration of a week. The intervention is designed to evaluate the potential effects of Gastrodia elata Blume on alleviating depressive symptoms, improving autonomic nervous system function, and enhancing overall quality of life in terminal cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Gastrodia elata Blume water extract | Experimental | Subjects will receive Gastrodia elata Blume water extract Receives: Dietary Supplement: Gastrodia elata Blume water extract |
| Gastrodia elata Blume water extract-like | Placebo comparator | Subjects will receive a placebo resembling Gastrodia elata Blume water extract Receives: Dietary Supplement: Gastrodia elata Blume water extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Depressive Symptoms
Hospital Anxiety and Depression Scale (HADS)
Outcome Measure Title: Hospital Anxiety and Depression Scale (HADS) Total Score Description: The HADS is a 14-item questionnaire used to measure anxiety and depression levels in participants. Each item is scored on a 4-point Likert scale ranging from 0 to 3, with separate scores calculated for the Anxiety subscale (HADS-A) and Depression subscale (HADS-D).
Minimum Score: 0 Maximum Score: 21 per subscale (42 total for both subscales combined) Interpretation: Higher scores indicate worse outcomes (greater severity of anxiety or depression).
Measured: 1 week
Improvement in Quality of Life
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Outcome Measure Title: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Description: The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients. It includes multi-item scales that evaluate global health status, functional domains (physical, role, emotional, cognitive, and social functioning), and symptom scales (e.g., fatigue, pain, nausea/vomiting).
Minimum Score: 0 Maximum Score: 100 for each scale (scores are linearly transformed to a 0-100 scale).
Interpretation: For global health status and functional scales, higher scores indicate better outcomes (better functioning or quality of life). For symptom scales, higher scores indicate worse outcomes (greater symptom burden).
Measured: 1 week
Changes in Pain Score
pain score
Outcome Measure Title:Pain Intensity Measurement Using the Numeric Pain Rating Scale (NPRS) Description of the Measurement Tool:The Numeric Pain Rating Scale (NPRS) is a self-reported measure commonly used to assess pain intensity. It asks participants to rate their pain on a scale from 0 (No Pain) to 10 (Worst Pain Possible). The scale is visualized using smiley faces, transitioning from green (mild/no pain) to red (severe pain).
Scoring Details:
Minimum Value: 0 (indicating no pain). Maximum Value: 10 (indicating the worst pain possible).
Interpretation:
Higher scores indicate worse outcomes (i.e., more severe pain). Lower scores indicate better outcomes (i.e., less or no pain).
Measured: 1 week
Changes in heart rate variability
Heart Rate Monitor (GSH751) is a non-invasive device approved by Taiwan's Ministry of Health (Certification No. 006983). It measures heart rate through finger electrodes and uses Bluetooth to transmit data for recording and analysis. The device evaluates heart rate variability (HRV) and autonomic nervous system function, including parameters like heart rate, SDNN (autonomic health indicator), sympathetic (LF), parasympathetic (HF) activity, and LF/HF balance index. Time domain and frequency domain analyses help assess stress, anxiety, sleep disorders, and overall autonomic balance, enabling users to track long-term health trends.
(Model: GSH751, Approved by Taiwan Ministry of Health, Certification No. 006983)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start14 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaw Shiun Tsai, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785623
- Sponsor's protocol ID
- 202409106RIND
- Acronym
- IDTCP
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Depression in Terminal Cancer Patients (IDTCP)
- ClinicalTrials.gov ID
- NCT06785623
- Acronym / sponsor ID
- IDTCP / 202409106RIND
- Keywords
- depression, terminal cancer patients, palliative care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- General examinations (e.g., height, weight, blood pressure).
- Non-invasive autonomic nervous system analyses.
- 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:
- Alleviate depressive symptoms.
- Enhance autonomic nervous system function.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrodia elata Blume water extract | Experimental | Dietary Supplement: Gastrodia elata Blume water extractSubjects will receive Gastrodia elata Blume water extract |
| Gastrodia elata Blume water extract-like | Placebo comparator | Dietary Supplement: Gastrodia elata Blume water extractSubjects will receive a placebo resembling Gastrodia elata Blume water extract |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrodia elata Blume water extractSubjects in the experimental group will consume Gastrodia elata Blume water extract daily. The extract is prepared from dried Gastrodia elata Blume, which is processed into a water-soluble form. This dosage is administered orally for a duration of a week. The intervention is designed to evaluate the potential effects of Gastrodia elata Blume on alleviating depressive symptoms, improving autonomic nervous system function, and enhancing overall quality of life in terminal cancer patients. | Dietary supplement | Gastrodia elata Blume water extract, Gastrodia elata Blume water extract-like |
Primary outcome
Reduction in Depressive Symptoms
Time frame: 1 week
Hospital Anxiety and Depression Scale (HADS) Outcome Measure Title: Hospital Anxiety and Depression Scale (HADS) Total Score Description: The HADS is a 14-item questionnaire used to measure anxiety and depression levels in participants. Each item is scored on a 4-point Likert scale ranging from 0 to 3, with separate scores calculated for the Anxiety subscale (HADS-A) and Depression subscale (HADS-D). Minimum Score: 0 Maximum Score: 21 per subscale (42 total for both subscales combined) Interpretation: Higher scores indicate worse outcomes (greater severity of anxiety or depression).
Improvement in Quality of Life
Time frame: 1 week
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Outcome Measure Title: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Description: The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients. It includes multi-item scales that evaluate global health status, functional domains (physical, role, emotional, cognitive, and social functioning), and symptom scales (e.g., fatigue, pain, nausea/vomiting). Minimum Score: 0 Maximum Score: 100 for each scale (scores are linearly transformed to a 0-100 scale). Interpretation: For global health status and functional scales, higher scores indicate better outcomes (better functioning or quality of life). For symptom scales, higher scores indicate worse outcomes (greater symptom burden).
Changes in Pain Score
Time frame: 1 week
pain score Outcome Measure Title:Pain Intensity Measurement Using the Numeric Pain Rating Scale (NPRS) Description of the Measurement Tool:The Numeric Pain Rating Scale (NPRS) is a self-reported measure commonly used to assess pain intensity. It asks participants to rate their pain on a scale from 0 (No Pain) to 10 (Worst Pain Possible). The scale is visualized using smiley faces, transitioning from green (mild/no pain) to red (severe pain). Scoring Details: Minimum Value: 0 (indicating no pain). Maximum Value: 10 (indicating the worst pain possible). Interpretation: Higher scores indicate worse outcomes (i.e., more severe pain). Lower scores indicate better outcomes (i.e., less or no pain).
Changes in heart rate variability
Time frame: 1 week
Heart Rate Monitor (GSH751) is a non-invasive device approved by Taiwan's Ministry of Health (Certification No. 006983). It measures heart rate through finger electrodes and uses Bluetooth to transmit data for recording and analysis. The device evaluates heart rate variability (HRV) and autonomic nervous system function, including parameters like heart rate, SDNN (autonomic health indicator), sympathetic (LF), parasympathetic (HF) activity, and LF/HF balance index. Time domain and frequency domain analyses help assess stress, anxiety, sleep disorders, and overall autonomic balance, enabling users to track long-term health trends. (Model: GSH751, Approved by Taiwan Ministry of Health, Certification No. 006983)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaw Shiun Tsai study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Gastrodia elata Blume water extract in people with Depression and Cancer Patients and Depression and Suicide, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen Yu Lin (+886-935-812-319, hannahlin1231@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Depressive Symptoms (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.