Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care

NCT ID: NCT04584775

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-07-31

Brief Summary

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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

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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

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Advanced Cancer Lung Cancer Breast Cancer Colo-rectal Cancer Pancreas Cancer Cholangiocarcinoma Quality of Life Symptoms and Signs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Traditional Chinese Medicine plus Standard Care versus Standard Care
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)

Intervention Type 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 care

Intervention Type OTHER

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.

Standard Care

The standard care will include any established medical intervention according to currently available guidelines in palliative care.

Group Type OTHER

Standard care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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Palliach

Identifier Type: -

Identifier Source: org_study_id

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