ANZCTR - Registration

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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]

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

cancer

neurotoxicity

Condition category

Condition code

Cancer

Any cancer

Neurological

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]

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]

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]

End of treatment visit - 6 weeks after first treatment.

Secondary outcome [1]

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)-13

Timepoint [1]

Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.

Secondary outcome [2]

Chemotherapy induced peripheral neuropathy, as measured by European Organisation for Research and Treatment of Cancer (EORTC QLQ-CIPN20)

Timepoint [2]

Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.

Secondary outcome [3]

Total Neuropathy Score (clinical).

Timepoint [3]

Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.

Secondary outcome [4]

Grade of peripheral neuropathy measured by Common Terminology Criteria for Adverse Events (CTC-AE v5).

Timepoint [4]

Compare baseline, end of treatment (6 weeks) and 6 weeks after completion of treatment.

Secondary outcome [5]

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]

Assessment of adverse events throughout study

Secondary outcome [6]

Physical function measured by Karnofsky Performance Status

Timepoint [6]

Compare baseline to end of treatment (6 weeks)

Secondary outcome [7]

Acceptability of treatment by participants.

Timepoint [7]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2020

Actual

Date of last participant enrolment

Anticipated

1/09/2020

Actual

Date of last data collection

Anticipated

1/01/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Concord Repatriation Hospital - Concord

Recruitment postcode(s) [1]

2139 - Concord

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Concord Cancer Centre

Address [1]

Hospital Rd, Concord NSW 2139

Country [1]

Australia

Primary sponsor type

Hospital

Name

Concord Cancer Centre

Address

Hospital Rd, Concord NSW 2139

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Sydney Local Health District HREC - Concord Repatriation General Hospital

Ethics committee address [1]

Hospital Road, Concord NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/11/2019

Approval date [1]

Ethics approval number [1]

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

Dr Christina Teng

Address

Concord Repatriation General Hospital
Department of Medical Oncology
Hospital Rd,
Concord NSW 2139

Country

Australia

Phone

+61 2 97676354

Fax

+61 2 97675764

[email protected]

Contact person for public queries

Name

Dr Christina Teng

Address

Concord Repatriation General Hospital
Department of Medical Oncology
Hospital Rd,
Concord NSW 2139

Country

Australia

Phone

+61 2 97676354

Fax

+61 2 97675764

[email protected]

Contact person for scientific queries

Name

Dr Christina Teng

Address

Concord Repatriation General Hospital
Department of Medical Oncology
Hospital Rd,
Concord NSW 2139

Country

Australia

Phone

+61 2 97676354

Fax

+61 2 97675764

[email protected]

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, [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5889	Informed consent form			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Evaluating laser photobiomodulation for chemotherapy-induced peripheral neuropathy: a randomised phase II trial.	2023	https://dx.doi.org/10.1007/s00520-022-07463-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically