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

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.

Study Overview

• Status: Completed
• Conditions: Cancer-related Fatigue
• Intervention / Treatment: Device: Infrared Laser Moxibustion; Device: Sham Infrared Laser Moxibustion

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Yueyang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infrared Laser Moxibustion Therapy; Each patient will receive this treatment twice per week for six weeks (12 sessions total).	Device: Infrared Laser Moxibustion; We will use SX10-C1 laser moxibustion devices (Shanghai Wonderful Opto-Electrics Tech Co Ltd, Shanghai, China) for the ILM and SILM groups. Four laser probes will be synchronously aligned with 4 points (tST36 (bilateral), CV4, and CV6 acupoints) and we will irradiate each acupoint 2 cm away from the skin surface for 20 minutes. Each patient will receive this treatment twice per week for six weeks (12 sessions total).
Sham Comparator: Sham Infrared Laser Moxibustion Therapy; The patients will receive treatment from sham laser moxibustion instrument.	Device: Sham Infrared Laser Moxibustion; The sham laser moxibustion instrument appears to be identical as the real one.
No Intervention: Waitlist Controls; The patients maintain their usual treatment and self-care,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline BFI-C at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0week; 3weeks；6weeks; 12weeks; 18weeks
Depression/Anxiety	The Chinese version of the Hospital Anxiety and Depression Scale (HADS): The HADS is a brief 14-item instrument, with seven items in each of the anxiety and depression scales that are scored from 0 to 3, resulting in scale scores that range from 0 to 21 Established cutoffs are: 0-7 not significant, 8-10 subclinical, and 11-21 clinically significant depression/anxiety.	0week; 3weeks；6weeks; 12weeks; 18weeks
Stress	The Chinese version of 10-Item Perceived Stress Scale (PSS-10) : It is a 10-item instrument and each question is rated on a 5-point Likert scale (0 = never to 4 = very often). A higher score indicates greater stress.	0week; 3weeks；6weeks; 12weeks; 18weeks
Insomnia	The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) : It is a 19-item self-report instrument that includes 7 component scores. The scores for these components range from 0 (no difficulty) to 3 (severe difficulty) and a higher score denoting poorer sleep quality (range: 0-21). It suggested a cut-off of the global score at ⩾8 for the presence of sleep disturbance in cancer patients.	0week; 3weeks；6weeks; 12weeks; 18weeks
Brief Pain Inventory	Chinese version of the Brief Pain Inventory (BPI)：It is a 11-item self-administered questionnaire that includes two main scores: a pain severity score (scored from 0 to 10, range from 0 to 40) and a pain interference score (scored from 0 to 10, range from 0 to 70). Higher scores represent worse pain.	0week; 3weeks；6weeks; 12weeks; 18weeks
Treatment Expectancy	Acupuncture Expectancy Scale (AES)：It is a 4-item instrument designed to assess outcome expectancy in acupuncture clinical trials, each with a 5-point Likert scale ranging from 1 to 5. The scores range between 4 and 20, with a higher score indicating greater expectancy.	0week; 3weeks；6weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Huijuan Mao, MD, Shanghai University of TCM

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; cancer-related fatigue; infrared laser moxibustion
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 81603703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No