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

Cancer-related Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553355
• Other study ID #: 81603703
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: July 27, 2021

Study information

• Verified date: August 2021
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 27, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

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 Infrared Laser Moxibustion
The sham laser moxibustion instrument appears to be identical as the real one.

Locations

Country	Name	City	State
China	Yueyang Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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