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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Infrared Laser Moxibustion

Sham Infrared Laser Moxibustion

About this trial

This is an interventional treatment trial for Cancer-related Fatigue focused on measuring infrared laser moxibustion, cancer-related fatigue, breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Yueyang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Infrared Laser Moxibustion Therapy

Sham Infrared Laser Moxibustion Therapy

Waitlist Controls

Arm Description

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

The patients will receive treatment from sham laser moxibustion instrument.

The patients maintain their usual treatment and self-care,

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03553355

First Posted

May 4, 2018

Last Updated

August 10, 2021

Sponsor

Shanghai University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03553355

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

June 20, 2018 (Actual)

Primary Completion Date

March 23, 2021 (Actual)

Study Completion Date

July 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer-related Fatigue

Keywords

infrared laser moxibustion, cancer-related fatigue, breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Infrared Laser Moxibustion Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Infrared Laser Moxibustion Therapy

Arm Type

Sham Comparator

Arm Description

The patients will receive treatment from sham laser moxibustion instrument.

Arm Title

Waitlist Controls

Arm Type

No Intervention

Arm Description

The patients maintain their usual treatment and self-care,

Intervention Type

Device

Intervention Name(s)

Infrared Laser Moxibustion

Intervention Description

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

Intervention Name(s)

Sham Infrared Laser Moxibustion

Intervention Description

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

Primary Outcome Measure Information:

Title

Chinese version of the Brief Fatigue Inventory (BFI-C)

Description

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.

Time Frame

Change from Baseline BFI-C at 6 weeks

Secondary Outcome Measure Information:

Title

Quality of Life (QOL)

Description

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.

Time Frame