Advanced CancerNCT04584775
Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care
A study testing Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics) in people with Advanced Cancer and Lung Cancer, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Cancer, Lung Cancer, Breast Cancer
- What is being tested?
- Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- o Exception: palliative anti-hormonal therapy or palliative radiotherapy
- Performance status: ECOG 0 to 2
- Estimated life expectancy > 4 months
Who cannot join
- Any serious concomitant systemic disorder
- Pregnancy or breast-feeding
- Impossibility to attend TCM practices in Graz
- Incapacity to comply/consent
- Language barrier
- Brain metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Cancer, Lung Cancer, Breast Cancer, Colo-rectal Cancer, Pancreas Cancer, Cholangiocarcinoma
- Being tested
- Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics), Standard care
- Keywords
- Palliative Care, Traditional Chinese Medicine, Acupuncture, Chinese Herbal Medicine
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Cholangiocarcinoma, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)Other
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.
Standard careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine plus Standard Care | Experimental | 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. Receives: Other: Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics); Other: Standard care |
| Standard Care | Other | The standard care will include any established medical intervention according to currently available guidelines in palliative care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study startFeb 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Covid19 Pandemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Traditional Chinese Medicine plus Standard Care versus Standard Care
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584775
- Sponsor's protocol ID
- Palliach
- Status last verified
- Jun 2024
- First submitted
- 6 Oct 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care: A Randomized Controlled Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT04584775
- Acronym / sponsor ID
- Palliach
- Conditions
- Advanced Cancer, Lung Cancer, Breast Cancer, Colo-rectal Cancer, Pancreas Cancer, Cholangiocarcinoma
- Keywords
- Palliative Care, Traditional Chinese Medicine, Acupuncture, Chinese Herbal Medicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid19 Pandemia
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Traditional Chinese Medicine plus Standard Care versus Standard Care
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine plus Standard Care | Experimental | Other: Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics), Other: Standard careParticipants 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. |
| Standard Care | Other | Other: Standard careThe standard care will include any established medical intervention according to currently available guidelines in palliative care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- One of the following tumor entities
- 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
Key exclusion criteria (6 listed)
- Any serious concomitant systemic disorder
- Pregnancy or breast-feeding
- Impossibility to attend TCM practices in Graz
- Incapacity to comply/consent
- Language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Traditional Chinese Medicine plus Standard Care |
| Standard careStandard 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, Traditional Chinese Medicine plus Standard Care |
Primary outcome
Change from baseline in FACT-G at week 4
Time frame: Baseline and 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.
5 secondary outcomes
Change from baseline in FACT-G at week 8
Time frame: Baseline and week 8
Change from baseline in PHQ-9 at week 4 and 8
Time frame: Baseline and week 4 and 8
Change of symptom burden, assessed by ESAS-R
Time frame: 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
Time frame: Daily from baseline to week 8
Change from baseline in FAMCARE-2 at week 4 and 8
Time frame: Baseline and week 4 and 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics) in people with Advanced Cancer and Lung Cancer, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in FACT-G at week 4 (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.