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

NCT ID: NCT03553355

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2021-07-27

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.

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.

Conditions

Cancer-related Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Infrared Laser Moxibustion Therapy

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

Group Type: EXPERIMENTAL

Infrared Laser Moxibustion

Intervention Type: 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).

Sham Infrared Laser Moxibustion Therapy

The patients will receive treatment from sham laser moxibustion instrument.

Group Type: SHAM_COMPARATOR

Sham Infrared Laser Moxibustion

Intervention Type: DEVICE

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

Waitlist Controls

The patients maintain their usual treatment and self-care,

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Sham Infrared Laser Moxibustion

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huijuan Mao, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai University of TCM

Locations

Yueyang Hospital

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31441863 (View on PubMed)

Other Identifiers

81603703

Identifier Type: -

Identifier Source: org_study_id