Clinical trial NCT02808624: L-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients
Official title: The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Neuropathy
Cancer
Keywords: Oxaliplatin, peripheral neuropathy, L-CARNOSINE
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Misr International University
name: Ain Shams University
First posted: 2016-06-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .

Detailed description: Oxaliplatin causes peripheral neuropathy , L-CARNOSINE is supposed to prevent this side effect possibly by reducing oxidative stress and enhancing the growth of nerves.This study is intended to clarify the effect and mechanism of action of L-CARNOSINE in preventing Oxaliplatin induced peripheral neuropathy in cancer patients.

Blood samples will be collected from the patients before starting the chemotherapy and at the end of treatment duration (3 months) and then oxidative stress markers will be measured in these samples

Eligibility criteria: Inclusion Criteria:

Patients are eligible to be enrolled in this study, if they meet the following criteria

1. Elderly males and females with age (˃18 and ˂60).
2. Cancer patients treated with oxaliplatin for the first time (dose 85- 135mg/m2) administered every two to three weeks for 3 months.

Exclusion Criteria:

Excluded from this study are the patients with the following Criteria:

* Suffering from diabetes mellitus.
* Suffering from peripheral neuropathy as a result of any other disease or drug.
* Suffering from severe renal impairment (CrCl ˂ 30 ml/min).
* Suffering from epilepsy.
* Taking vitamin B.
* Who previously took Oxaliplatin or any other chemotherapeutic agent that causes peripheral neuropathy.
* Taking antidepressants or MAOI's.
* Taking NSAIDs, paracetamol, opiates or any other analgesics or pain killers.
* Pregnant or lactating patients.

Primary outcomes:
measure: Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.
timeFrame: Three months
Secondary outcomes:
measure: Assessment of tumor markers (CA,CEA) in blood.
timeFrame: Three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Kasr el Aini
Study officials:
affiliation: Cairo University
name: Samira Saleh, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Hanan elabhar, Professor
role: STUDY_CHAIR
affiliation: Misr International University
name: Mona Schaalan, assoc. prof.
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Amr Shafik, Assoc. Prof
role: STUDY_CHAIR
References: