Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732455
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2021-01-16
Brief Title:
Lidocaine Versus Duloxetine for the Prevention of Taxane-Induced Peripheral Neuropathy In Breast Cancer Patients
Sponsor:
Gamal Mohamed Taha Abouelmagd
Organization:
Alexandria University
Study Overview
Official Title:
Intravenous Lidocaine Infusion Versus Oral Duloxetine For The Prevention And Treatment Of Chemotherapy Induced Peripheral Neuropathy Among Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIPN
Brief Summary:
The aim of the study is to evaluate the effect of intravenous IV lidocaine versus oral duloxetine on the onset and severity of TIPN in patient with breast cancer as well as evaluation of Patients quality of life and estimation the cell mediated immunity
The current study is a single blinded randomized controlled study assumed that lidocaine could prevent and reduce TIPN similar to duloxetine in patient with breast cancer
Method of randomization The allocation sequence was generated using permuted block randomization technique and the block size was variable Allocation sequencecode was concealed from the person allocating the participants to the intervention arms using sealed opaque envelopes
Primary outcome Degree of neuropathic pain measured by neuropathy pain scale NPS among breast cancer patients on Taxane chemotherapy after the pretreatment with either lidocaine or duloxetine
Secondary outcomes are The incidence of TIPN using DN4 questionnaire and nerve conduction study and Patients quality of life using The European Organization for Research and Treatment of Cancer EORTC QLQ-CIPN20 as well as the Change in serum level natural killer cell to estimate cell mediated immunity
The current study is a single blinded randomized controlled study assumed that lidocaine could prevent and reduce TIPN similar to duloxetine in patient with breast cancer
Method of randomization The allocation sequence was generated using permuted block randomization technique and the block size was variable Allocation sequencecode was concealed from the person allocating the participants to the intervention arms using sealed opaque envelopes
Primary outcome Degree of neuropathic pain measured by neuropathy pain scale NPS among breast cancer patients on Taxane chemotherapy after the pretreatment with either lidocaine or duloxetine
Secondary outcomes are The incidence of TIPN using DN4 questionnaire and nerve conduction study and Patients quality of life using The European Organization for Research and Treatment of Cancer EORTC QLQ-CIPN20 as well as the Change in serum level natural killer cell to estimate cell mediated immunity
Detailed Description:
Patients assessment
Medical history Previous diseases and medications
Clinical examination and laboratory investigations according to patient condition
Each patient will be informed with the study its expected result and its possible side effects The patients will be trained to use neuropathic pain scale NPS Additionally DN4 questionnaire will be explained to all participants IV line will be inserted for all participants Vital signs including heart rate and mean arterial blood pressure will be measured
The participants will be randomly allocated into three groups as follows
Group control C 20 adult breast cancer patients on Taxane chemo protocol will receive 200 ml normal saline over forty minutes pre each chemotherapy session until end of the cycle
Group lidocaine infusion L 20 adult breast cancer patients on Taxane chemo protocol will receive lidocaine IV infusion 2 mgkg in 200ml saline over forty minutes with a maximum upper limit of 200 mg pre each chemotherapy session until end of the cycle If any selected patient reported neuropathic pain DN4 4 during the course of chemotherapy lidocaine 2 mgkg re-infused after each session If lidocaine side effects such as circumoral numbness twitches metal test tachy or bradycardia recorded at any time lidocaine infusion will be reduced to 1mgkg if side effects persist the patients will be managed accordingly as well as lidocaine infusion will be stopped and patient will be excluded from the study
Group duloxetine D 20 adult breast cancer patients on chemotherapy will take oral duloxetine tablet 30 mg once per day starting from the night pre chemotherapy session until the end of cycle If any selected patient reported neuropathic pain DN4 4 during the course of chemotherapy the duloxetine dose will be adjusted to 60 mg daily till the end of the cycle They also will receive 200 ml normal saline over forty minutes before each chemotherapy session until end of the cycle
Measurements
Demographic features of the patients
-Age years Weight kg
Neuropathic pain characters and severity
-Intensity and characters of neuropathic pain will be measured by neuropathic pain scale 0-10cm after each chemotherapy session which is expected to be one session every week for 12 weeks
Chemotherapy induced peripheral neuropathy
Nerve conduction study will be performed to detect sensory peripheral neuropathy pre and immediately after the end of chemo protocol cycle
Detection of TIPN will be measured using DN4 questionnaire before starting chemotherapy protocol and after each chemotherapy session which is expected to be one session every week for 12 weeks
Patients quality of life -The European Organization for Research and Treatment of Cancer EORTC QLQ-CIPN20 questionnaire for quality of life will be taken from patient before starting chemotherapy protocol one month two month after the treatment and at the end of treatment
Cell mediated immunity Natural killer cell isolation and cytotoxicity assay
-Sample of 1ml of patients peripheral blood will be collected on EDTA for flow cytometry to enumerate for both cytotoxic lymphocytes population NK cells and cytotoxic lymphocytes ctls CD 56 will be used as a market for NK cells while CD8 will be used as a marker for Ctls Cytotoxic assay will be done by measuring the release of lactate dehydrogenase LDH from non-viable cells Cytotoxicity Detection kit 630117 Clontech laboratories Mountain View California according to manufacturers instructions Then ratio of LDH released specifically from NK cells will be carried according to the result of flow cytometry Blood Sample will be collected at the start and the end of chemo protocol cycle of breast cancer patients
Complications
-Any complications will occur during or after the treatment with lidocaine or duloxetine will be reported and managed accordingly
Medical history Previous diseases and medications
Clinical examination and laboratory investigations according to patient condition
Each patient will be informed with the study its expected result and its possible side effects The patients will be trained to use neuropathic pain scale NPS Additionally DN4 questionnaire will be explained to all participants IV line will be inserted for all participants Vital signs including heart rate and mean arterial blood pressure will be measured
The participants will be randomly allocated into three groups as follows
Group control C 20 adult breast cancer patients on Taxane chemo protocol will receive 200 ml normal saline over forty minutes pre each chemotherapy session until end of the cycle
Group lidocaine infusion L 20 adult breast cancer patients on Taxane chemo protocol will receive lidocaine IV infusion 2 mgkg in 200ml saline over forty minutes with a maximum upper limit of 200 mg pre each chemotherapy session until end of the cycle If any selected patient reported neuropathic pain DN4 4 during the course of chemotherapy lidocaine 2 mgkg re-infused after each session If lidocaine side effects such as circumoral numbness twitches metal test tachy or bradycardia recorded at any time lidocaine infusion will be reduced to 1mgkg if side effects persist the patients will be managed accordingly as well as lidocaine infusion will be stopped and patient will be excluded from the study
Group duloxetine D 20 adult breast cancer patients on chemotherapy will take oral duloxetine tablet 30 mg once per day starting from the night pre chemotherapy session until the end of cycle If any selected patient reported neuropathic pain DN4 4 during the course of chemotherapy the duloxetine dose will be adjusted to 60 mg daily till the end of the cycle They also will receive 200 ml normal saline over forty minutes before each chemotherapy session until end of the cycle
Measurements
Demographic features of the patients
-Age years Weight kg
Neuropathic pain characters and severity
-Intensity and characters of neuropathic pain will be measured by neuropathic pain scale 0-10cm after each chemotherapy session which is expected to be one session every week for 12 weeks
Chemotherapy induced peripheral neuropathy
Nerve conduction study will be performed to detect sensory peripheral neuropathy pre and immediately after the end of chemo protocol cycle
Detection of TIPN will be measured using DN4 questionnaire before starting chemotherapy protocol and after each chemotherapy session which is expected to be one session every week for 12 weeks
Patients quality of life -The European Organization for Research and Treatment of Cancer EORTC QLQ-CIPN20 questionnaire for quality of life will be taken from patient before starting chemotherapy protocol one month two month after the treatment and at the end of treatment
Cell mediated immunity Natural killer cell isolation and cytotoxicity assay
-Sample of 1ml of patients peripheral blood will be collected on EDTA for flow cytometry to enumerate for both cytotoxic lymphocytes population NK cells and cytotoxic lymphocytes ctls CD 56 will be used as a market for NK cells while CD8 will be used as a marker for Ctls Cytotoxic assay will be done by measuring the release of lactate dehydrogenase LDH from non-viable cells Cytotoxicity Detection kit 630117 Clontech laboratories Mountain View California according to manufacturers instructions Then ratio of LDH released specifically from NK cells will be carried according to the result of flow cytometry Blood Sample will be collected at the start and the end of chemo protocol cycle of breast cancer patients
Complications
-Any complications will occur during or after the treatment with lidocaine or duloxetine will be reported and managed accordingly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None