Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy

NCT05199389 | Active Not Recruiting DMC

• 1 other identifier: 2021/155
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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 (three 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 (three 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 (three 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 (three weeks post-baseline)

• Quality of life score

  Three weeks post-PBM

• Satisfaction score

  Baseline

• Satisfaction score

  End of PBM (three weeks post-baseline)

Other Outcomes (8)

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

  Baseline

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

  End of PBM (three weeks post-baseline)

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

  Three weeks post-PBM

Study Arms (2)

PBM1 group

EXPERIMENTAL

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

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

PBM2 group

EXPERIMENTAL

The patients allocated to the first PBM-group will receive six PBM sessions of 8 J/cm² over three 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.

PBM1 group; PBM2 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Study Officials

• Jeroen Mebis, Prof. Dr.

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

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: January 6, 2022
• First Posted: January 20, 2022
• Study Start: January 31, 2022
• Primary Completion: November 15, 2023
• Study Completion (Estimated): November 10, 2028
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

BE (1)