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

May 21, 2020 updated by: The University of Hong Kong

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Haiyong CHEN, PhD
  • Phone Number: 852-39176413
  • Email: haiyong@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the symptom improvments
Time Frame: 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)
Change from baseline score at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-C15-PAL
Time Frame: 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)
weeks 0, 3, 7 and 11
Numeric Rating Scale
Time Frame: 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)
weeks 0, 3, 7 and 11
Fatigue
Time Frame: 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.
weeks 0, 3, 7 and 11
The Hospital Anxiety and Depression Scale
Time Frame: 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.
weeks 0, 3, 7 and 11
The Insomnia Severity Index
Time Frame: 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.
weeks 0, 3, 7 and 11
Symptom improvments
Time Frame: 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)
weeks 0, 1, 2, 7 and 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

March 31, 2023

Study Completion (ANTICIPATED)

August 31, 2023

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (ACTUAL)

May 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 19-822

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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