Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03553355|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer-related Fatigue||Device: Infrared Laser Moxibustion Device: Sham Infrared Laser Moxibustion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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,
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Huijuan Mao, MD||(0086)-firstname.lastname@example.org|
|Contact: Huanjun Mao, MD|
|Principal Investigator:||Huijuan Mao, MD||Shanghai University of TCM|