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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-08-31

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).

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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.

Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture and standard care (ASC)

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Sham acupuncture and standard care (SSC)

Intervention Type OTHER

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

SC

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

Group Type PLACEBO_COMPARATOR

Standard care (SC)

Intervention Type OTHER

Standard care will be employed.

Interventions

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Acupuncture and standard care (ASC)

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

Intervention Type OTHER

Sham acupuncture and standard care (SSC)

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

Intervention Type OTHER

Standard care (SC)

Standard care will be employed.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No