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

The University of Hong Kong30 enrolled

Overview

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.

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 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, 10, 14. Secondary outcomes: Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer Therapy-Breast Cancer, 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Insomnia, Secondary Breast Cancer Female Chemotherapy

Interventions

AcupunctureDEVICE

Electroacupuncture (EA) and Auricular Acupuncture (AA)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female patients between 18 and 75 years of age; 2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer; 3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months; 4. Insomnia onset after the diagnosis of breast cancer; 5. 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; 6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks; 7. Expected survival time of more than 6 months; 8. Ability to understand the nature of the study and willingness to give informed consent; 9. Ability to provide responses during outcome measurement. Exclusion Criteria: 1. Insomnia before the diagnosis of breast cancer; 2. Other sleep disorder (e.g., obstructive sleep apnoea); 3. Shift work or irregular sleep pattern; 4. Severe visual, hearing or language defects; 5. Severe hematological dysfunction (platelet count \<60,000/μL, haemoglobin \<8 g/dL or absolute neutrophil count \<1000/μL); 6. With pacemakers or other electronic implants that could interfere with electroacupuncture; 7. History of acupuncture use in the previous 3 months; 8. Participation in other clinical trials with intervention within 3 months of the beginning of the trial.

Locations (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Change in Insomnia Severity Index (ISI)

Time frame: week 0, 3, 6 (primary outcome), 10, 14

Secondary Outcomes

Pittsburgh Sleep Quality Index

Time frame: week 0, 3, 6, 10, 14

Sleep diary

Time frame: week 0, 6

Actigraphy

Time frame: week 0, 6

Functional Assessment of Cancer Therapy-Breast Cancer

Time frame: week 0, 6, 10, 14

Adverse events

Time frame: week 0 to week 6

Data from ClinicalTrials.gov

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