Brief Title
Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care
Official Title
Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care: A Randomized Controlled Open-label Clinical Trial
Brief Summary
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
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
Primary Outcome
Change from baseline in FACT-G at week 4
Secondary Outcome
Change from baseline in FACT-G at week 8
Condition
Advanced Cancer
Intervention
Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)
Study Arms / Comparison Groups
Traditional Chinese Medicine plus Standard Care
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
80
Start Date
February 2021
Completion Date
July 2022
Primary Completion Date
April 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT04584775
Organization ID
Palliach
Responsible Party
Sponsor
Study Sponsor
Medical University of Graz
Study Sponsor
, ,
Verification Date
December 2020