PBMT for the Prevention of CIPN

NCT03391271 | Completed

• 1 other identifier: CIPN-112017
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

ne of the most common cancers in women worldwide is breast cancer. A common used therapy in early-stage and metastatic breast cancer involves chemotherapy. Taxanes, microtubule-targeting agents (MTAs), are one of the most used chemotherapeutic agents in breast cancer patients. Unfortunately, this treatment comes with many unfortunate side effects. Chemotherapy-induced peripheral neuropathy (CIPN) is one of these common side effects. This condition involves paresthesia, numbness and/or burning pain in distal limbs. Eventually, loss of temperature sensation, loss of tendon reflexes and pain sensation can occur. Yet, no therapies have been developed to treat CIPN. At the moment, only symptom management is possible. Not only will this condition affect the patients' daily activities, but a chemotherapy dose reduction could also be necessary, influencing the outcome and overall survival rate of the patient. A new and emerging treatment for CIPN is photobiomodulation therapy (PBMT) or low-level laser therapy. During PBMT, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves. Studies have shown positive results for patients with diabetic neuropathy. However, no studies have been undertaken specifically for taxane-induced neuropathy (TIN). We hypothesize that PBMT is an effective treatment strategy to prevent sensory symptoms associated with TIN. This can lead to an improved quality of life for the patient and no need for a chemotherapy dose reduction.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• The modified total neuropathy score (mTNS)

  he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN.

  baseline

• The modified total neuropathy score (mTNS)

  he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN.

  week 6

• The modified total neuropathy score (mTNS)

  he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN.

  week 12

• The modified total neuropathy score (mTNS)

  he mTNS is a composite scale that includes patient report of sensory and motor symptoms, pin sensibility, quantitative vibration thresholds, strength using manual muscle tests, and deep tendon reflexes. The higher the score, the more severe the peripheral neuropathy. The mTNS is a clinically applicable, sensitive screening tool for CIPN.

  week 15

Secondary Outcomes (8)

• Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)

  baseline

• Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)

  week 6

• Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)

  week 12

• Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Taxane scale (FACT/GOG-Taxane)

  week 15

• Pain evaluation

  baseline

Study Arms (2)

photobiomodulation therapy (PBMT)

EXPERIMENTAL

During photobiomodulation therapy (PBMT) or low-level laser therapy, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves

Other: photobiomodulation therapy (PBMT)

Placebo group

PLACEBO COMPARATOR

No PBMT

Other: sham laser sessions

Interventions

photobiomodulation therapy (PBMT) OTHER

Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy) • The PBMT-group will receive twice-weekly laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy)

photobiomodulation therapy (PBMT)

sham laser sessions OTHER

• The control group will undergo twice-weekly sham laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy). The laser device will be placed on the same manner and for the same period of time on the identified body sites, but the device will not be switched on.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
• Age 18 years or above
• Are planned to undergo at least 3 cycles of taxane treatment (i.e. paclitaxel or docetaxel)
• Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis).
• Signed informed consent

You may not qualify if:

• Have a history of neuropathy before taxane treatment due to other medical conditions: diabetes, peripheral vascular disease, HIV infection, significant degenerative or familial neurologic disorder, nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression)
• Taking stable doses of medication on prescription or dietary supplements for peripheral neuropathy. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12; Patients need to agree not to initiate a new therapy two weeks before and during the study period.
• Metastatic disease
• Have a diagnosis of ethanol addiction or dependence within the past 10 years.
• Concurrent chemotherapy with neurotoxic chemotherapeutic agents (i.e. platinum compounds or vinca alcaloids)
• Severe or unstable cardio- respiratory or musculoskeletal disease

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Related Publications (1)

• Joy L, Jolien R, Marithe C, Stijn E, Laura S, Hilde L, Sandra B, Wendy N, Ruth H, Liesbeth R, Sylvana S, Sylvia H, Jeroen M. The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial). Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21.

  PMID: 35312857 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• jeroen Mebis, prof. dr.

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: January 5, 2018
• Study Start: November 13, 2017
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

BE (1)