NCT04398875

Brief Summary

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

May 18, 2020

Last Update Submit

May 21, 2020

Conditions

Advanced Cancer

Keywords

advanced cancerpalliative careacupuncture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • EORTC QLQ-C15-PAL

    weeks 0, 3, 7 and 11

  • Numeric Rating Scale

    weeks 0, 3, 7 and 11

  • Fatigue

    weeks 0, 3, 7 and 11

  • The Hospital Anxiety and Depression Scale

    weeks 0, 3, 7 and 11

  • The Insomnia Severity Index

    weeks 0, 3, 7 and 11

  • +1 more secondary outcomes

Study Arms (3)

ASC

EXPERIMENTAL

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)

SSC

SHAM COMPARATOR

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)

SC

PLACEBO COMPARATOR

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

Other: Standard care (SC)

Interventions

Acupuncture and standard care (ASC)OTHER

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

ASC
Sham acupuncture and standard care (SSC)OTHER

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

SSC
Standard care (SC)OTHER

Standard care will be employed.

SC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen H, So TH, Cho WC, Qin Z, Ma CH, Li SG, Yang Z, Jiang F, Wu J, Zhang ZJ, Kong FM, Lao L. The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: Study Protocol for a 3-Arm Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211012749. doi: 10.1177/15347354211012749.

    PMID: 33957783DERIVED

MeSH Terms

Interventions

Acupuncture TherapyStandard of Care

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Haiyong CHEN, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyong CHEN, PhD

CONTACT

852-39176413haiyong@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects randomly assigned to either ASC group or SSC group will be blinded to their group assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

September 1, 2020

Primary Completion

March 31, 2023

Study Completion

August 31, 2023

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share