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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553355
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Cancer-related Fatigue Device: Infrared Laser Moxibustion Device: Sham Infrared Laser Moxibustion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : May 28, 2020
Estimated Study Completion Date : July 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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,



Primary Outcome Measures :
  1. Chinese version of the Brief Fatigue Inventory (BFI-C) [ Time Frame: Change from Baseline BFI-C at 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: 0week; 3weeks;6weeks; 12weeks; 18weeks ]
    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.

  2. Depression/Anxiety [ Time Frame: 0week; 3weeks;6weeks; 12weeks; 18weeks ]
    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.

  3. Stress [ Time Frame: 0week; 3weeks;6weeks; 12weeks; 18weeks ]
    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.

  4. Insomnia [ Time Frame: 0week; 3weeks;6weeks; 12weeks; 18weeks ]
    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.

  5. Brief Pain Inventory [ Time Frame: 0week; 3weeks;6weeks; 12weeks; 18weeks ]
    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.

  6. Treatment Expectancy [ Time Frame: 0week; 3weeks;6weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553355


Contacts
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Contact: Huijuan Mao, MD (0086)-021-51322358 maohuijuan1977@hotmail.com

Locations
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China
Yueyang Hospital Recruiting
Shanghai, China
Contact: Huanjun Mao, MD         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Huijuan Mao, MD Shanghai University of TCM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03553355    
Other Study ID Numbers: 81603703
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai University of Traditional Chinese Medicine:
infrared laser moxibustion
cancer-related fatigue
breast cancer
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms