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.

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.

Standard care alone (SC) will be provided. Subjects in the SC group will standard care for 3 weeks.

A semi-standardized treatment protocol and standard care will be employed.

Acupuncture and standard care (ASC)

Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied.

Sham acupuncture and standard care (SSC)

Standard care (SC)

Haiyong CHEN, PhD

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).

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.

Subjects randomly assigned to either ASC group or SSC group will be blinded to their group assignment

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

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

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)

The European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL)

The Numeric Rating Scale measures the pain intensity, which is scored from 0-100mm. (no pain at 0 mm, the worst pain at 100mm)

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 (HADS) consists of 14 items. Each item is scored from 0-3. Total score ranges between 0 and 21 for either anxiety or depression.

The Insomnia Severity Index (ISI) has 7 items. Each item is sored from 0 to 4. Total scale ranges from 0 t0 28.

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjunctive Effect of Acupuncture for Advanced Cancer Patients With Palliative Care: a Three-arm Randomized Trial	NCT04398875	Advanced Cancer	Acupuncture and... Sham acupunctur... Standard care (...	18 Years -	The University of Hong Kong
Adjunctive Effect of Acupuncture for Advanced Cancer Patients With Palliative Care: a Three-arm Randomized Trial	NCT04398875	Advanced Cancer	Acupuncture and... Sham acupunctur... Standard care (...	18 Years -	The University of Hong Kong

Spots Global Cancer Trial Database for acupuncture and standard care (asc)