Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients

Shanghai University of Traditional Chinese Medicine140 enrolled

Overview

Cancer-related fatigue (CRF) is the most common and distressing symptom associated with tumor or cancer treatment that breast cancer survivors (BCS) experience.The investigators previously found the laser moxibustion was potentially efficacious for CRF; however, more rigorously designed study is needed to confirm its benefit. The primary aim of this study is to determine the efficacy of 10.6µm infrared laser moxibustion and its long-term effects on CRF. Secondary aims are to evaluate the effect of infrared laser moxibustion on co-existing symptoms such as among BCS experiencing CRF.

The randomized, placebo-controlled, three-arm trial will be conducted to evaluate the efficacy of infrared laser moxibustion (ILM) and sham ILM (SILM) compared to waitlist control (WLC) for moderately to severely fatigued BCS. The two intervention groups will receive real/sham infrared laser moxibustion on four acupoints (e.g. ST36 (bilateral), CV4, and CV6) for 20 minutes each session for six weeks (two times per week). The primary endpoint is the change in fatigue scores from Baseline to Week 6 as measured by the Chinese version of the Brief Fatigue Inventory (BFI-C). Our secondary aims are to compare the severity of comorbidities (e.g. depression, insomnia, and pain) and biological outcomes (e.g. telomere length) among the three groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Cancer-related Fatigue

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 years and 75 years * Breast cancer survivors with a diagnosis of stage I-IIIa * Cessation of cancer-related treatments (e.g. surgery, chemotherapy, radiotherapy) at least 12 weeks before the trial, with the exception of hormonal and trastuzumab therapy * Complaint of fatigue starting on or after their cancer diagnosis,Brief Fatigue Inventory score of ≥ 4 Exclusion Criteria: * Severe anemia (platelet count \<60,000/μL,hemoglobin \<8 g/dL, or leukocyte count\<3000/μL) * Abnormal findings in a thyroid function test (abnormal level of free thyroxine and thyroid stimulating hormone \<0.1 μIU/ml or TSH\> 5.1 μIU/ml) * Having received acupuncture for any indication in the previous 4 weeks or having received acupuncture test within the past 6 months. * Untreated major depressive disorder and suicidal ideations. * Pregnant or planning to become pregnant

Outcomes

Primary Outcomes

Chinese version of the Brief Fatigue Inventory (BFI-C)

The Chinese version of the Brief Fatigue Inventory (BFI) : It uses 10-point numeric descriptions: scores of 1 to 3 represent mild levels of fatigue, scores of 4 to 6 represent moderate levels of fatigue, and scores of 7 to 10 represent severe levels of fatigue.

Time frame: Change from Baseline BFI-C at 6 weeks

Secondary Outcomes

Quality of Life (QOL)

The Chinese version of the Functional Assessment of Cancer Therapy-Breast (FACT-B) : It is a 37-item instrument and each question is rated on a 5-point Likert scale. Higher scores represent improved global quality of life.