Clinical trial NCT03553355: Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients
Official title: Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Fatigue
Keywords: infrared laser moxibustion
cancer-related fatigue
breast cancer
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Chinese version of the Brief Fatigue Inventory (BFI-C)
timeFrame: Change from Baseline BFI-C at 6 weeks
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: 0week; 3weeks；6weeks; 12weeks; 18weeks
measure: Depression/Anxiety
timeFrame: 0week; 3weeks；6weeks; 12weeks; 18weeks
measure: Stress
timeFrame: 0week; 3weeks；6weeks; 12weeks; 18weeks
measure: Insomnia
timeFrame: 0week; 3weeks；6weeks; 12weeks; 18weeks
measure: Brief Pain Inventory
timeFrame: 0week; 3weeks；6weeks; 12weeks; 18weeks
measure: Treatment Expectancy
timeFrame: 0week; 3weeks；6weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yueyang Hospital
Study officials:
affiliation: Shanghai University of TCM
name: Huijuan Mao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mao H, Mao JJ, Chen J, Li Q, Chen X, Shen X, Zhao L, Wei J, Shen X. Effects of infrared laser moxibustion on cancer-related fatigue in breast cancer survivors: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Aug;98(34):e16882. doi: 10.1097/MD.0000000000016882.