NCT03762694

Brief Summary

This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

December 2, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 26, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

December 2, 2018

Last Update Submit

April 24, 2022

Conditions

Insomnia, SecondaryBreast Cancer FemaleChemotherapy

Keywords

AcupunctureInsomniaBreast cancerChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in Insomnia Severity Index (ISI)

    week 0, 3, 6 (primary outcome), 10, 14

Secondary Outcomes (5)

  • Pittsburgh Sleep Quality Index

    week 0, 3, 6, 10, 14

  • Sleep diary

    week 0, 6

  • Actigraphy

    week 0, 6

  • Functional Assessment of Cancer Therapy-Breast Cancer

    week 0, 6, 10, 14

  • Adverse events

    week 0 to week 6

Study Arms (2)

Electroacupuncture (EA) and Auricular Acupuncture (AA)

EXPERIMENTAL

12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.

Device: Acupuncture

Wait-list control

NO INTERVENTION

No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.

Interventions

AcupunctureDEVICE

Electroacupuncture (EA) and Auricular Acupuncture (AA)

Electroacupuncture (EA) and Auricular Acupuncture (AA)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients between 18 and 75 years of age;
  • Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;
  • Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;
  • Insomnia onset after the diagnosis of breast cancer;
  • Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder;
  • Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;
  • Expected survival time of more than 6 months;
  • Ability to understand the nature of the study and willingness to give informed consent;
  • Ability to provide responses during outcome measurement.

You may not qualify if:

  • Insomnia before the diagnosis of breast cancer;
  • Other sleep disorder (e.g., obstructive sleep apnoea);
  • Shift work or irregular sleep pattern;
  • Severe visual, hearing or language defects;
  • Severe hematological dysfunction (platelet count \<60,000/μL, haemoglobin \<8 g/dL or absolute neutrophil count \<1000/μL);
  • With pacemakers or other electronic implants that could interfere with electroacupuncture;
  • History of acupuncture use in the previous 3 months;
  • Participation in other clinical trials with intervention within 3 months of the beginning of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Zhang J, Qin Z, So TH, Chen H, Lam WL, Yam LL, Yan Chan P, Lao L, Zhang ZJ. Electroacupuncture Plus Auricular Acupressure for Chemotherapy-Associated Insomnia in Breast Cancer Patients: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019103. doi: 10.1177/15347354211019103.

    PMID: 34036813DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersBreast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2018

First Posted

December 4, 2018

Study Start

March 26, 2019

Primary Completion

June 9, 2020

Study Completion

October 31, 2020

Last Updated

April 26, 2022

Record last verified: 2022-04

Locations

HK(1)