NCT05763706

Brief Summary

This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Mar 2023Mar 2030

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2030

Expected
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 28, 2023

Last Update Submit

March 28, 2023

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Photobiomodulation therapy

Outcome Measures

Primary Outcomes (9)

  • Modified total neuropathy score (mTNS)

    The mTNS is a clinically applicable, sensitive screening tool for CIPN. The score ranges from 0 to 24, with a higher score indicating a higher level of neuropathy.

    Baseline

  • Modified total neuropathy score (mTNS)

    The mTNS is a clinically applicable, sensitive screening tool for CIPN. The score ranges from 0 to 24, with a higher score indicating a higher level of neuropathy.

    End of PBM (six weeks post-baseline)

  • Modified total neuropathy score (mTNS)

    The mTNS is a clinically applicable, sensitive screening tool for CIPN. The score ranges from 0 to 24, with a higher score indicating a higher level of neuropathy.

    Three weeks post-PBM

  • Pain score

    The patients' pain due to CIPN will be evaluated by using a numerical rating scale (NRS). The score ranges from 0 to 10, with a higher score indicating a higher level of pain.

    Baseline

  • Pain score

    The patients' pain due to CIPN will be evaluated by using a numerical rating scale (NRS). The score ranges from 0 to 10, with a higher score indicating a higher level of pain.

    End of PBM (six weeks post-baseline)

  • Pain score

    The patients' pain due to CIPN will be evaluated by using a numerical rating scale (NRS). The score ranges from 0 to 10, with a higher score indicating a higher level of pain.

    Three weeks post-PBM

  • Mobility score

    The mobility of the patients will be measured using the six minute walk test. This test measures the distance the patient can walk in six minutes and compares it to the normal value for their age and BMI.

    Baseline

  • Mobility score

    The mobility of the patients will be measured using the six minute walk test. This test measures the distance the patient can walk in six minutes and compares it to the normal value for their age and BMI.

    End of PBM (six weeks post-baseline)

  • Mobility score

    The mobility of the patients will be measured using the six minute walk test. This test measures the distance the patient can walk in six minutes and compares it to the normal value for their age and BMI.

    Three weeks post-PBM

Secondary Outcomes (6)

  • Quality of life score

    Baseline

  • Quality of life score

    End of PBM (six weeks post-baseline)

  • Quality of life score

    Three weeks post-PBM

  • Satisfaction score

    Baseline

  • Satisfaction score

    End of PBM (six weeks post-baseline)

  • +1 more secondary outcomes

Other Outcomes (8)

  • General patient-, disease-, and treatment-related information

    Baseline

  • General patient-, disease-, and treatment-related information

    End of PBM (six weeks post-baseline)

  • General patient-, disease-, and treatment-related information

    Three weeks post-PBM

  • +5 more other outcomes

Study Arms (2)

Experimental: PBM1 group

EXPERIMENTAL

The patients allocated to the first PBM-group will receive twelve PBM sessions of 6 J/cm² over six weeks (2x/week).

Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)

Experimental: PBM2 group

EXPERIMENTAL

The patients allocated to the second PBM-group will receive twelve PBM sessions of 8 J/cm² over six weeks (2x/week).

Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)

Interventions

Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)DEVICE

MLS® Laser M6 is a PBM device that allows the patients to be treated in various positions, either sitting, lying down or at a distance, without risk of contamination. Treatment times are carefully calibrated to deliver the best possible energy dose to the tissue being treated.

Experimental: PBM1 groupExperimental: PBM2 group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib.
  • Diagnosed with CIPN
  • Age 18 years or above
  • Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
  • Dutch-speaking
  • Signed informed consent

You may not qualify if:

  • Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.
  • Severe or unstable cardio- respiratory or musculoskeletal disease
  • Interruption of more than two consecutive laser treatments
  • Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

Study Officials

  • Jeroen mebis, Prof. Dr.

    Jessa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Mebis, Prof. Dr.

CONTACT

011 33 72 21jeroen.mebis@jessazh.be

Marithé Claes, MSc

CONTACT

011 33 72 39marithe.claes@uhasselt.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

March 27, 2023

Primary Completion

March 15, 2025

Study Completion (Estimated)

March 15, 2030

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

BE(1)