Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJessa Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
DeviceMLS® 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.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: Experimental: PBM1 groupExperimental treatment 1 intervention
Group B: Experimental: PBM2 groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
End of PBM (six weeks post-baseline)3
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.
Time frame
Three weeks post-PBM4
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.
Time frame
BaselineSecondary outcomes
1
Quality of life score
The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT/GOG-NTX) is a validated patient questionnaire to test the quality of life of the patients with CIPN. The score ranges from 0 to 152, with a higher score indicating a lower quality of life.
Time frame
Baseline2
Quality of life score
The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT/GOG-NTX) is a validated patient questionnaire to test the quality of life of the patients with CIPN. The score ranges from 0 to 152, with a higher score indicating a lower quality of life.
Time frame
End of PBM (six weeks post-baseline)3
Quality of life score
The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT/GOG-NTX) is a validated patient questionnaire to test the quality of life of the patients with CIPN. The score ranges from 0 to 152, with a higher score indicating a lower quality of life.
Time frame
Three weeks post-PBM4
Satisfaction score
The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).
Time frame
BaselineOther outcomes
1
General patient-, disease-, and treatment-related information
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).
Time frame
Baseline2
General patient-, disease-, and treatment-related information
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).
Time frame
End of PBM (six weeks post-baseline)3
General patient-, disease-, and treatment-related information
General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).
Time frame
Three weeks post-PBM4
Cancer relapse or recurrence
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Time frame
One year post chemotherapySponsors and contacts
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Source ClinicalTrials.gov