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

Shanghai University of Traditional Chinese Medicine

Status: Completed

Conditions: Cancer-related Fatigue

Treatments: Device: Sham Infrared Laser Moxibustion; Device: Infrared Laser Moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT03553355

81603703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 3 patient groups

Infrared Laser Moxibustion Therapy

Experimental group

Description:

Each patient will receive this treatment twice per week for six weeks (12 sessions total).

Treatment:

Device: Infrared Laser Moxibustion

Sham Infrared Laser Moxibustion Therapy

Sham Comparator group

Description:

The patients will receive treatment from sham laser moxibustion instrument.

Treatment:

Device: Sham Infrared Laser Moxibustion

Waitlist Controls

No Intervention group

Description:

The patients maintain their usual treatment and self-care,