Improvement of Depression in Terminal Cancer Patients

NCT ID: NCT06785623

Last Updated: 2025-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2025-12-31

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.

Conditions

Depression; Cancer Patients and Depression and Suicide; Life Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Gastrodia elata Blume water extract

Subjects will receive Gastrodia elata Blume water extract

Group Type: EXPERIMENTAL

Gastrodia elata Blume water extract

Intervention Type: 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-like

Subjects will receive a placebo resembling Gastrodia elata Blume water extract

Group Type: PLACEBO_COMPARATOR

Gastrodia elata Blume water extract

Intervention Type: 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.

Interventions

Gastrodia elata Blume water extract

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaw Shiun Tsai

Role: STUDY_CHAIR

National Taiwan University Hospital

Central Contacts

Yen Yu Lin

Role: CONTACT

hannahlin1231@gmail.com

+886-935-812-319

Jaw Shiun Tsai

Role: CONTACT

jawshiun@ntu.edu.tw

+886-223123456 ext. 265147

Other Identifiers

202409106RIND

Identifier Type: -

Identifier Source: org_study_id