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Cancer-related FatigueNCT03553355

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

A study testing Infrared Laser Moxibustion in people with Cancer-related Fatigue, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cancer-related Fatigue
What is being tested?
Infrared Laser Moxibustion
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteChina
Study dates
20 Jun 2018to 27 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Yueyang Hospital

    Shanghai

Other trials in China

About this study

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.

Read the 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.

Being tested
Infrared Laser Moxibustion, Sham Infrared Laser Moxibustion
Keywords
infrared laser moxibustion, cancer-related fatigue, breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infrared Laser MoxibustionDevice

    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 MoxibustionDevice

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

Study groups in NCT03553355
Study groupRoleWhat they receive
Infrared Laser Moxibustion TherapyExperimentalEach patient will receive this treatment twice per week for six weeks (12 sessions total).
Receives: Device: Infrared Laser Moxibustion
Sham Infrared Laser Moxibustion TherapySham comparatorThe patients will receive treatment from sham laser moxibustion instrument.
Receives: Device: Sham Infrared Laser Moxibustion
Waitlist ControlsNo interventionThe patients maintain their usual treatment and self-care,

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from Baseline BFI-C at 6 weeks

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

    Measured: 0week; 3weeks；6weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study start20 Jun 2018
  3. Primary completion23 Mar 2021
  4. Study completion27 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03553355
Sponsor's protocol ID
81603703
Status last verified
Aug 2021
First submitted
4 May 2018
Last updated
11 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31441863

Questions about this trial

What is this clinical trial studying?

A study testing Infrared Laser Moxibustion in people with Cancer-related Fatigue, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chinese version of the Brief Fatigue Inventory (BFI-C) (time frame: Change from Baseline BFI-C at 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03553355, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.

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