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

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Advanced Cancer

Treatments: Other: Standard care (SC); Other: Acupuncture and standard care (ASC); Other: Sham acupuncture and standard care (SSC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04398875

UW 19-822

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

ASC

Experimental group

Description:

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.

Treatment:

Other: Acupuncture and standard care (ASC)

SSC

Sham Comparator group

Description:

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.

Treatment:

Other: Sham acupuncture and standard care (SSC)

SC

Placebo Comparator group

Description:

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

Treatment:

Other: Standard care (SC)