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Trial registered on ANZCTR


Registration number
ACTRN12619001672145p
Ethics application status
Submitted, not yet approved
Date submitted
19/11/2019
Date registered
28/11/2019
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
LANTERN - LAser Nerve ThERapy for chemotherapy Neurotoxicity
Scientific title
LANTERN (LAser Nerve ThERapy for chemotherapy Neurotoxicity):
Randomized controlled phase 2 trial evaluating laser photobiomodulation for the treatment of chemotherapy-induced peripheral neuropathy (CIPN)
Secondary ID [1] 299859 0
Nil known
Universal Trial Number (UTN)
U1111-1243-9403
Trial acronym
LANTERN
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
chemotherapy-induced peripheral neuropathy 315264 0
cancer 315265 0
neurotoxicity 315266 0
Condition category
Condition code
Cancer 313563 313563 0 0
Any cancer
Neurological 313564 313564 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Photobiomodulation (PBM) involves non-ionising, low power, laser light which has anti-inflammatory and regenerative effects. Laser PBM is the study intervention in this trial. Patients receive laser PBM twice per week for 6 consecutive weeks, a total of 12 sessions. During the intervention the laser is applied to the interdigital spaces of the hands and feet and the C6-T1 and L5-S1 nerve roots bilaterally.
Duration of the treatment will be approximately 30 minutes, twice a week for 6 weeks. Each point will receive a starting dose of 1 Joule for the first session, then escalated to 2 Joules per point for subsequent sessions as tolerated. The intervention will be administered by a medical professional accredited in laser safety. Each treatment, including any adverse effects, will be recorded on a case report form.
Laser treatment will be given to patients at least 3 months following completion of their systemic chemotherapy. Patients who have not completed chemotherapy are not eligible to participate.
Intervention code [1] 316118 0
Treatment: Devices
Comparator / control treatment
Sham therapy intervention consists of the same procedures as the laser intervention but with the laser aperture occluded by an opaque cover.
Control group
Placebo

Outcomes
Primary outcome [1] 322019 0
CIPN response is defined as the proportion of patients in each arm who experience either:
• resolution of symptoms from any score to zero on FACT/GOG-Ntx 13 subscale
• reduction in FACT/GOG-Ntx 13 subscale by 4 points (the minimally important difference)
Timepoint [1] 322019 0
End of treatment visit - 6 weeks after first treatment.
Secondary outcome [1] 377033 0
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)-13
Timepoint [1] 377033 0
Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.
Secondary outcome [2] 377034 0
Chemotherapy induced peripheral neuropathy, as measured by European Organisation for Research and Treatment of Cancer (EORTC QLQ-CIPN20)
Timepoint [2] 377034 0
Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.
Secondary outcome [3] 377035 0
Total Neuropathy Score (clinical).
Timepoint [3] 377035 0
Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.
Secondary outcome [4] 377036 0
Grade of peripheral neuropathy measured by Common Terminology Criteria for Adverse Events (CTC-AE v5).
Timepoint [4] 377036 0
Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.
Secondary outcome [5] 377038 0
Safety of PBM, assessed by number and severity of adverse events of interest, (eg. symptom flare, fatigue, local irritation) to be recorded on case report forms.
Timepoint [5] 377038 0
Assessment of adverse events throughout study
Secondary outcome [6] 377039 0
Physical function measured by Karnofsky Performance Status
Timepoint [6] 377039 0
Compare baseline to end of treatment (6 weeks)
Secondary outcome [7] 377040 0
Acceptability of treatment by participants.
Timepoint [7] 377040 0
End of treatment questionnaire answered by patients at end of treatment (6 weeks). Questionnaire is not validated and is designed specifically for the study.

Eligibility
Key inclusion criteria
1. Males or females with chemotherapy-induced peripheral neuropathy symptoms;
2. At least 3 months following last exposure to neurotoxic chemotherapy, including taxane and platinum classes
3. Age >18 years
4. Agree not to undertake any complementary therapy for peripheral neuropathy for the duration of participation on the study
5. Speak and read sufficient English to answer the questionnaires
6. Available for treatment and follow up visits
7. Signed, written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to lie supine for a 30-minute period
2. Open wound or ulcer over the treatment area
3. Clinical diagnosis of peripheral neuropathy from another cause, eg. diabetic peripheral neuropathy, B12 or folate deficiency, alcoholic neuropathy, or demyelination. Note diabetes is not a specific exclusion.
4. Uncontrolled psychiatric illness, dementia or cognitive dysfunction that in the opinion of the principal investigator may interfere with the ability to complete neurotoxicity assessments
5. Life expectancy of <3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allcoation via email randomised by NHMRC clinical trials centre
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The total sample size will be 45 patients allowing for 10% attrition. This calculation is based on Simon's two-stage design (Simon, 1989). The null hypothesis that the true response rate is 5% will be tested against a one-sided alternative. In the first stage, 13 participants will be accrued to the intervention arm. If there are no responses in these 13 patients, the study will be stopped. Otherwise, 14 additional participants will be accrued for a total of 27 in the intervention arm. The null hypothesis will be rejected if 4 or more responses are observed in 27 patients. This design yields a type I error rate of 5% and power of 80% when the rate of response on treatment is 20%. Control participants will be recruited in a 2:1 (intervention: control) ratio until the target of 27 active participants is achieved. The estimated number of participants recruited to the control arm is 15.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15268 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 28577 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 304321 0
Hospital
Name [1] 304321 0
Concord Cancer Centre
Address [1] 304321 0
Hospital Rd, Concord NSW 2139
Country [1] 304321 0
Australia
Primary sponsor type
Hospital
Name
Concord Cancer Centre
Address
Hospital Rd, Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 304565 0
None
Name [1] 304565 0
Address [1] 304565 0
Country [1] 304565 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304770 0
Sydney Local Health District HREC - Concord Repatriation General Hospital
Ethics committee address [1] 304770 0
Hospital Road, Concord NSW 2139
Ethics committee country [1] 304770 0
Australia
Date submitted for ethics approval [1] 304770 0
25/11/2019
Approval date [1] 304770 0
Ethics approval number [1] 304770 0

Summary
Brief summary
The study aims to assess whether laser treatment (also called photobiomodulation) can help with neurotoxicity from chemotherapy. Photobiomodulation is the use of a low-power laser to improve the nerve damage.

Who is it for?
You may be eligible for this study if you are male or female, aged 18 years or older with chemotherapy-induced peripheral neuropathy symptoms. There must be at least 3 months following last exposure to neurotoxic chemotherapy, including taxane and platinum classes.

Study details
All participants in the study will be randomly allocated (50/50) chance to one of the following treatments:
1. Laser treatment to the hands, feet and back for 6 weeks.
2. The control treatment, which is the same (including laser treatment), however the laser source is covered up. This means people in the control group do not know which treatment they are getting. During the study, the participants wear black goggles to prevent them from identifying their treatment. While on the study, participants will be asked about their symptoms, their day-to-day function and have a physical exam focused on nerves.

It is hoped this laser treatment will improve nerve symptoms in the patient population and help inform a larger study with more patients.
Trial website
Trial related presentations / publications
Public notes
2-minute video containing general study information available via the link below:
https://youtu.be/kvC4i5qaepQ

Contacts
Principal investigator
Name 98146 0
Dr Christina Teng
Address 98146 0
Concord Repatriation General Hospital
Department of Medical Oncology
Hospital Rd,
Concord NSW 2139
Country 98146 0
Australia
Phone 98146 0
+61 2 97676354
Fax 98146 0
+61 2 97675764
Email 98146 0
christina.teng1@health.nsw.gov.au
Contact person for public queries
Name 98147 0
Dr Christina Teng
Address 98147 0
Concord Repatriation General Hospital
Department of Medical Oncology
Hospital Rd,
Concord NSW 2139
Country 98147 0
Australia
Phone 98147 0
+61 2 97676354
Fax 98147 0
+61 2 97675764
Email 98147 0
christina.teng1@health.nsw.gov.au
Contact person for scientific queries
Name 98148 0
Dr Christina Teng
Address 98148 0
Concord Repatriation General Hospital
Department of Medical Oncology
Hospital Rd,
Concord NSW 2139
Country 98148 0
Australia
Phone 98148 0
+61 2 97676354
Fax 98148 0
+61 2 97675764
Email 98148 0
christina.teng1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De identified patient reported outcome and toxicity data on request and by agreement of investigators.
When will data be available (start and end dates)?
Following analysis and publication, estimated June - December 2021, and for 12 months after publication.
Available to whom?
Researchers on request
Available for what types of analyses?
At discretion of investigators, to achieve aims as stated in the protocol.
How or where can data be obtained?
Access subject to approval by investigators - email principal investigator, Christina.teng1@health.nsw.gov.au
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 5889 0
Informed consent form
Citation [1] 5889 0
Link [1] 5889 0
Email [1] 5889 0
Christina.teng1@health.nsw.gov.au
Other [1] 5889 0
Attachment [1] 5889 0
Summary results
No Results