Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care

Study Overview
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Brief Summary
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In this clinical trial we want to investigate the clinical benefit of a complementary therapy using therapeutical modalities of the traditional chinese medicine in patients suffering from advanced cancer.

Detailed Description
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After giving informed consent, the participants will be randomized into two groups (1:1). Both groups will receive standard care while one group will additionally be assigned to a practitioner of traditional Chinese medicine (TCM) who will deliver a individual treatment according to the needs of the participant (pragmatic approach). Outcome measures will be monitored over the course of eight weeks.

Official Title
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Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care: A Randomized Controlled Open-label Clinical Trial

Conditions
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Advanced Cancer, Lung Cancer, Breast Cancer, Colo-rectal Cancer, Pancreas Cancer, Cholangiocarcinoma, Quality of Life, Symptoms and Signs

Intervention / Treatment
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* Other: Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One of the following tumor entities Colorectal cancer (CRC) Lung cancer (SCLC, NSCLC) Breast cancer (BC) Pancreas/Cholangiocellular cancer Best supportive care (i.e., no currently ongoing tumor-specific therapy) o Exception: palliative anti-hormonal therapy or palliative radiotherapy Performance status: ECOG 0 to 2 Estimated life expectancy > 4 months Exclusion Criteria: Any serious concomitant systemic disorder Pregnancy or breast-feeding Impossibility to attend TCM practices in Graz Incapacity to comply/consent Language barrier Brain metastases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Traditional Chinese Medicine plus Standard Care versus Standard Care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Chinese Medicine plus Standard Care<br>Participants in this group will receive standard Palliative Care and will additionally see a practitioner of Traditional Chinese Medicine. No strict protocol for the actual intervention exists (pragmatic approach). The participants will at least receive acupuncture and/or chinese herbal medicine. The standard care will include any established medical intervention according to currently available guidelines in palliative care. | Other: Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)<br>* Acupuncture is a physical treatment modality that uses thin needles to stimulate specific points on the body in order to manipulate neurologic mechanisms to control specific symptoms and/or physiologic processes. Chinese herbal medicine is a phytotherapeutic treatment modality that uses herbs, minerals and rarely animal products which are orally administered. Tuina is a form of massage and physical therapy. Chinese dietetics is a nutritional therapy according to the theoretical principle of traditional Chinese medicine.<br>Other: Standard care<br>* Standard care includes any medical intervention in palliative care that aims to promote and/or sustain the quality of life of patients suffering from advanced disease (in this case cancer). These may be of pharmaceutical, surgical, psychological and/or spiritual nature.<br>|
| Other: Standard Care<br>The standard care will include any established medical intervention according to currently available guidelines in palliative care. | Other: Standard care<br>* Standard care includes any medical intervention in palliative care that aims to promote and/or sustain the quality of life of patients suffering from advanced disease (in this case cancer). These may be of pharmaceutical, surgical, psychological and/or spiritual nature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FACT-G at week 4 | FACT-G ((Functional Assessment of Cancer Therapy - General) is a validated multi-dimensional quality of life (QoL) questionnaire. It consists of 26 items and addresses four dimensions of QoL, including physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), and social wellbeing (SWB). The scoring system is a five-point Likert scale assessing the QoL of the past seven days. The FACT-G total score has a range of 0-108, whereas higher scores indicate a higher QoL. | Baseline and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FACT-G at week 8 | FACT-G is a validated multi-dimensional quality of life questionnaire. It consists of 26 items and addresses four dimensions of QoL, including physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), and social wellbeing (SWB). The scoring system is a five-point Likert scale assessing the QoL of the past seven days. The FACT-G total score has a range of 0-108, whereas higher scores indicate a higher QoL. | Baseline and week 8 | 
| Change from baseline in PHQ-9 at week 4 and 8 | The PHQ-9 (Patient Health Questionnaire) aims at depressive disorders in medically ill populations. It is a 9-item diagnostic tool based upon the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders IV) criteria for major depressive disorder. The PHQ-9 score has a range of 0-27, whereas a score above 10 indicates major depression, This questionnaire will also be completed by a close caregiver (family or friend). | Baseline and week 4 and 8 | 
| Change of symptom burden, assessed by ESAS-R | The ESAS-R (Edmonton Symptom Assessment Scale revised) was established specifically for palliative care patients and is a nine-item patient-rated symptom visual analog scale. Each item is rated by a numerical rating scale (0-10), whereas higher numbers indicate a more severe symptom experience. The total score of all symptoms represents the total symptom-burden, whereas a higher score indicates a higher total symptom-burden. | Baseline and weekly until week 8 | 
| Change in use of Pro re nata medication (P.R.N.M.), assessed by Pro re nata medication diary | To assess the use of pro re nata medication, the participants will document their usage in a diary. P.R.N.M. may be antiemetics, analgetics, tranquilizers or any other drug used for acute symptom relieve. | Daily from baseline to week 8 | 
| Change from baseline in FAMCARE-2 at week 4 and 8 | To evaluate the satisfaction of advanced cancer care in family or friends caregivers, the family satisfaction with end-of-life care two questionnaire (FAMCARE-2) will be used. It is a 17-item assessment tool using a Likert scale (score: 0-68), including subscales for information giving, physical patient care, psychosocial care, and availability of care. A high score on the FAMCARE-2 is associated with a high satisfaction with the palliative care service. This questionnaire will only be completed by a close caregiver (family or friend). | Baseline and week 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Traditional Chinese Medicine, Acupuncture, Chinese Herbal Medicine