Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life; Breast Cancer; Lung Cancer; Cholangiocarcinoma; Advanced Cancer; Pancreas Cancer; Colo-rectal Cancer; Symptoms and Signs
• Intervention / Treatment: Other: Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics); Other: Standard care

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Chinese Medicine plus Standard Care; 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); 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.; Other: Standard care; 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.
Other: Standard Care; The standard care will include any established medical intervention according to currently available guidelines in palliative care.	Other: Standard care; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Performance Scales at week 4 and 8	The Karnofsky Performance Scale describes a patient's ability to perform daily activities without restrictions due to disease through to death on a scale of 100 to 0, in steps of 10. Additionally, the ECOG (Eastern Cooperative Oncology Group) Performance Scale, which is a six-grade scale that assesses the level of functioning in terms of self-care, activity, and physical ability, will be assessed.	Baseline and week 4 and 8
Number of consultations of the mobile palliative care team	Throughout the course of the study, the number of consultations of the mobile palliative care team will be documented and compared between the two groups.	From baseline to week 8
Number of hospital referrals	Throughout the course of the study, hospital referrals will be documented and compared between the two groups.	From baseline to week 8
Length of hospitalizations	Throughout the course of the study, the length of hospitalizations will be documented and compared between the two groups.	From baseline to week 8
Overall survival	All deaths throughout the course of the study will be documented to calculate the overall survival.	From baseline to week 8.

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2021
• Primary Completion (Estimated): April 1, 2022
• Study Completion (Estimated): July 1, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture; Chinese Herbal Medicine; Palliative Care; Traditional Chinese Medicine
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Cholangiocarcinoma
• Other Study ID Numbers: Palliach

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No