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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Other: Acupuncture and standard care (ASC)
* Other: Sham acupuncture and standard care (SSC)
* Other: Standard care (SC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC<br>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. | Other: Acupuncture and standard care (ASC)<br>* A semi-standardized treatment protocol and standard care will be employed.<br>|
| Sham Comparator: SSC<br>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. | Other: Sham acupuncture and standard care (SSC)<br>* Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied.<br>|
| Placebo Comparator: SC<br>Standard care alone (SC) will be provided. Subjects in the SC group will standard care for 3 weeks. | Other: Standard care (SC)<br>* Standard care will be employed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced cancer, palliative care, acupuncture