Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care

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 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

, , 

Location Countries

Austria

Location Countries

Austria

NCT ID

NCT04584775

Organization ID

Palliach

Responsible Party

Sponsor

Study Sponsor

Medical University of Graz

Study Sponsor

, , 

Verification Date

December 2020