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The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy

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ClinicalTrials.gov Identifier: NCT03762694
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Professor LAO Lixing, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Insomnia, Secondary Breast Cancer Female Chemotherapy Device: Acupuncture Not Applicable

Detailed Description:

Hypothesis:

Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a wait-list control.

Objective:

To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the wait-list control group.

Design and strategy:

This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list control. All patients in the 2 groups will receive routine Western medical care for symptom management.

Study instrument:

Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.

Intervention:

In the treatment group, 12 sessions acupuncture treatment (electroacupuncture & auricular acupressure) will be given twice a week for 6 weeks (2 chemotherapy cycle) after randomization. In the wait-list control group, no treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as treatment group.

Main outcome measures:

Primary outcome: ISI scores will be measured at week 0, 3, 6, 9, 12.

Secondary outcomes:

Pittsburgh Sleep Quality Index, Sleep diary, Actigraphy, Functional Assessment of Cancer Therapy-Breast Cancer, EQ-5D-5L, and adverse events will be documented and compared between groups.

Data analysis: The primary endpoint will be the continuous ISI score. For the primary analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test on the average ISI score will be performed to access the significance of the treatment effects; otherwise, a nonparametric approach will be taken.

Expected outcome: ISI score of the acupuncture group is expected to be significantly lower than wait-list control group after 6 weeks of treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electroacupuncture (EA) and Auricular Acupuncture (AA)
12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks (2 chemotherapy cycle) after randomization.
Device: Acupuncture
Electroacupuncture (EA) and Auricular Acupuncture (AA)

No Intervention: Wait-list control
No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.



Primary Outcome Measures :
  1. Change in Insomnia Severity Index (ISI) [ Time Frame: week 0, 3, 6, 9, 12 ]

Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index [ Time Frame: week 0, 3, 6, 9, 12 ]
  2. Sleep diary [ Time Frame: week 0, 3, 6, 9, 12 ]
  3. Actigraphy [ Time Frame: week 0, 6 ]
  4. Functional Assessment of Cancer Therapy-Breast Cancer [ Time Frame: week 0, 6, 9, 12 ]
  5. EQ-5D-5L [ Time Frame: week 0, 6, 9, 12 ]
  6. Adverse events [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients between 18 and 75 years of age;
  2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-III nonmetastatic breast cancer;
  3. Completion of breast cancer removal surgery and current adjuvant chemotherapy including doxorubicin, cyclophosphamide, taxotere or paclitxe;
  4. Insomnia symptoms as defined by an ISI score of no less than 8 in the past 2 weeks;
  5. Insomnia onset after chemotherapy;
  6. Expected survival time of more than 6 months;
  7. Ability to understand the nature of the study and willingness to give informed consent;
  8. Ability to provide responses during outcome measurement.

Exclusion Criteria:

  1. Insomnia before chemotherapy;
  2. Other sleep disorder (e.g., obstructive sleep apnoea);
  3. Shift work or irregular sleep pattern;
  4. Major depressive disorder, generalised anxiety disorder, panic disorder, manic or hypomanic episodes, substance use disorders aside from caffeine or nicotine use, organic mental disorder, schizophrenia or any other psychotic disorder;
  5. Cognitive impairment with score lower than 18 (the score is adjusted according to the level of educational attainment) on Cantonese version of Mini-Mental Status Examination;
  6. Severe visual, hearing or language defects;
  7. Severe anaemia (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);
  8. BMI > 35 kg/m2;
  9. Pregnancy, lactation or planning to become pregnant;
  10. History of acupuncture use in the previous 6 months;
  11. Participation in other clinical trials within 3 months of the beginning of the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762694


Contacts
Contact: Jialing Zhang +852 9249 3025 zhangjl0@hku.hk

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

Responsible Party: Professor LAO Lixing, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03762694     History of Changes
Other Study ID Numbers: UW 18-526
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor LAO Lixing, The University of Hong Kong:
Acupuncture
Insomnia
Breast cancer
Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders