Improvement of Depression in Terminal Cancer Patients

NCT06785623 | Not Yet Recruiting

• 1 other identifier: 202409106RIND
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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. 1.General examinations (e.g., height, weight, blood pressure).
2. 2.Non-invasive autonomic nervous system analyses.
3. 3.Patient-reported measures: Quality of Life Scale (EORTC QLQ-C30), Pain Score, and Hospital Anxiety and Depression Scale (HADS).
4. 4.Alleviate depressive symptoms.
5. 5.Enhance autonomic nervous system function.
6. 6.Improve the quality of life for terminal cancer patients.

Conditions

Depression; Cancer Patients and Depression and Suicide; Life Quality

Keywords

depression; terminal cancer patients; palliative care

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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)

  1 week

Study Arms (2)

Gastrodia elata Blume water extract

EXPERIMENTAL

Subjects will receive Gastrodia elata Blume water extract

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

Dietary Supplement: Gastrodia elata Blume water extract

Interventions

Gastrodia elata Blume water extract DIETARY_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.

Gastrodia elata Blume water extract; Gastrodia elata Blume water extract-like

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Depression; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior

Study Officials

• Jaw Shiun Tsai

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Yen Yu Lin

CONTACT

+886-935-812-319; hannahlin1231@gmail.com

Jaw Shiun Tsai

CONTACT

+886-223123456; jawshiun@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 21, 2025
• Study Start: January 14, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share