Clinical trial NCT04584775: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Advanced Cancer
Lung Cancer
Breast Cancer
Colo-rectal Cancer
Pancreas Cancer
Cholangiocarcinoma
Quality of Life
Symptoms and Signs
Keywords: Palliative Care
Traditional Chinese Medicine
Acupuncture
Chinese Herbal Medicine
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Traditional Chinese Medicine plus Standard Care versus Standard Care
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in FACT-G at week 4
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change from baseline in FACT-G at week 8
timeFrame: Baseline and week 8
measure: Change from baseline in PHQ-9 at week 4 and 8
timeFrame: Baseline and week 4 and 8
measure: Change of symptom burden, assessed by ESAS-R
timeFrame: Baseline and weekly until week 8
measure: Change in use of Pro re nata medication (P.R.N.M.), assessed by Pro re nata medication diary
timeFrame: Daily from baseline to week 8
measure: Change from baseline in FAMCARE-2 at week 4 and 8
timeFrame: Baseline and week 4 and 8
Other outcomes:
measure: Change from baseline in Performance Scales at week 4 and 8
timeFrame: Baseline and week 4 and 8
measure: Number of consultations of the mobile palliative care team
timeFrame: From baseline to week 8
measure: Number of hospital referrals
timeFrame: From baseline to week 8
measure: Length of hospitalizations
timeFrame: From baseline to week 8
measure: Overall survival
timeFrame: From baseline to week 8.
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References: