Adjunctive Effect of Acupuncture for Advanced Cancer Patients With Palliative Care: a Three-arm Randomized Trial

Advanced Cancer Clinical Trial

Official title:

The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: a Three-arm Pragmatic Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04398875
• Other study ID #: UW 19-822
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2020
• Source: The University of Hong Kong
• Contact: Haiyong CHEN, PhD
• Phone: 852-39176413
• Email: haiyong[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).

Description:

After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage IIIB or IV;

• Aged 18 years or above;

• Expected survival time longer than 16 weeks;

Exclusion Criteria:

• Disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count < 35000/µL; INR > 1.5; hemoglobin = 90 g/dL; white blood cell count = 4x109/L;

• Uncontrolled active skin infection;

• Needle phobia;

• Inability to read and understand Chinese;

• Not signed written informed consent.

• Receiving surgery during the whole study period;

• Receiving acupuncture treatment in the last 3 months

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Other:
• Acupuncture and standard care (ASC)
A semi-standardized treatment protocol and standard care will be employed.
• Sham acupuncture and standard care (SSC)
Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied.
• Standard care (SC)
Standard care will be employed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the symptom improvments	The Edmonton Symptom Assessment System (ESAS) is used to rate the intensity of nine common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)	Change from baseline score at 3 weeks
Secondary	EORTC QLQ-C15-PAL	The European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL)	weeks 0, 3, 7 and 11
Secondary	Numeric Rating Scale	The Numeric Rating Scale measures the pain intensity, which is scored from 0-100mm. (no pain at 0 mm, the worst pain at 100mm)	weeks 0, 3, 7 and 11
Secondary	Fatigue	The Chinese version of Brief Fatigue Inventory (BFI) is a 9-item, 11-point rating scale developed to assess subjective fatigue.	weeks 0, 3, 7 and 11
Secondary	The Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale (HADS) consists of 14 items. Each item is scored from 0-3. Total score ranges between 0 and 21 for either anxiety or depression.	weeks 0, 3, 7 and 11
Secondary	The Insomnia Severity Index	The Insomnia Severity Index (ISI) has 7 items. Each item is sored from 0 to 4. Total scale ranges from 0 t0 28.	weeks 0, 3, 7 and 11
Secondary	Symptom improvments	The Edmonton Symptom Assessment System (ESAS) consists of 9 common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)	weeks 0, 1, 2, 7 and 11