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

NCT03553355 | Completed

• 1 other identifier: 81603703
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Fatigue

Keywords

infrared laser moxibustion; cancer-related fatigue; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of Life (QOL)

  0week; 3weeks；6weeks; 12weeks; 18weeks

• Depression/Anxiety

  0week; 3weeks；6weeks; 12weeks; 18weeks

• Stress

  0week; 3weeks；6weeks; 12weeks; 18weeks

• Insomnia

  0week; 3weeks；6weeks; 12weeks; 18weeks

• Brief Pain Inventory

  0week; 3weeks；6weeks; 12weeks; 18weeks

Study Arms (3)

Infrared Laser Moxibustion Therapy

EXPERIMENTAL

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

Device: Infrared Laser Moxibustion

Sham Infrared Laser Moxibustion Therapy

SHAM COMPARATOR

The patients will receive treatment from sham laser moxibustion instrument.

Device: Sham Infrared Laser Moxibustion

Waitlist Controls

NO INTERVENTION

The patients maintain their usual treatment and self-care,

Interventions

Infrared Laser Moxibustion DEVICE

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).

Infrared Laser Moxibustion Therapy

Sham Infrared Laser Moxibustion DEVICE

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

Sham Infrared Laser Moxibustion Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Yueyang Hospital

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 31441863 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Huijuan Mao, MD

  Shanghai University of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 12, 2018
• Study Start: June 20, 2018
• Primary Completion: March 23, 2021
• Study Completion: July 27, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Locations

CN (1)