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

Not Applicable

• Conditions: Advanced Cancer
• Interventions: Other: Sham acupuncture and standard care (SSC); Other: Standard care (SC); Other: Acupuncture and standard care (ASC)

• Registration Number: NCT04398875
• Lead Sponsor: The University of Hong Kong

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-21
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-21
• Study Start: 2020-09-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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;

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSC	Sham acupuncture and standard care (SSC)	Sham acupuncture plus standard care (SSC) will be provided. Subjects in the SSC group will receive 9 sessions of sham acupuncture and standard care for 3 weeks. The Streitberger sham acupuncture will be employed. The selection of acupoints is the same as ASC.
SC	Standard care (SC)	Standard care alone (SC) will be provided. Subjects in the SC group will standard care for 3 weeks.
ASC	Acupuncture and standard care (ASC)	Traditional manual acupuncture with standard care (ASC) will be provided. Subjects in the ASC group will receive 9 sessions of acupuncture and standard care for 3 weeks. A semi-standardized acupuncture treatment protocol (combined fixed acupoints with additional acupoints by symptom differentiation) will be employed. The fixed acupuncture points including, Guanyuan (CV4), Xuanzhong(GB39), Sanyinjiao (SP6), Yinlingquan (SP9), Zusanli (ST36), Yingtang (EX-HN3), Baihui (GV20), and Qihai (CV6) will be used in every session.

Primary Outcome Measures

Name	Time	Method
Change of the symptom improvments	Change from baseline score at 3 weeks	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)

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C15-PAL	weeks 0, 3, 7 and 11	The European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL)
Numeric Rating Scale	weeks 0, 3, 7 and 11	The Numeric Rating Scale measures the pain intensity, which is scored from 0-100mm. (no pain at 0 mm, the worst pain at 100mm)
Symptom improvments	weeks 0, 1, 2, 7 and 11	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)
The Insomnia Severity Index	weeks 0, 3, 7 and 11	The Insomnia Severity Index (ISI) has 7 items. Each item is sored from 0 to 4. Total scale ranges from 0 t0 28.
Fatigue	weeks 0, 3, 7 and 11	The Chinese version of Brief Fatigue Inventory (BFI) is a 9-item, 11-point rating scale developed to assess subjective fatigue.
The Hospital Anxiety and Depression Scale	weeks 0, 3, 7 and 11	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.