A Phase 2 interventional study of Memantine-HCl and Placebo Oral Tablet in Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Ain Shams University · Phase 2, Interventional, and Prevention
Cancer is currently a leading cause of morbidity and mortality worldwide. Chemotherapeutic agents, despite being effective in arresting the progression of cancer by targeting and eliminating rapidly dividing cancer cells, are associated with various adverse effects. Chemotherapy-induced peripheral neuropathy (CIPN) is a serious clinical adverse effect of certain chemotherapeutic agents. For many patients, CIPN symptoms could be severe, disabling, and significantly impairing the activities of daily living (ADL) and diminishing the quality of life (QoL). Paclitaxel-induced peripheral neuropathy may affect up to 97% of paclitaxel-treated patients and become chronic in more than 60% of cases. The initial symptoms of paclitaxel-induced peripheral neuropathy (PIPN) include numbness, tingling, and allodynia (painful sensations in response to normally non-painful stimuli) that can be manifested in the patient's fingers and toes within 24-72 h post-injection. These symptoms may later progress to affect the patient's lower leg and wrists in a "glove and stocking" pattern. Symptoms typically begin distally and continue proximally as the situation worsens. Memantine is a non-competitive NMDA receptor antagonist that inhibits the prolonged influx of Ca2+, responsible for neuronal excitotoxicity while maintaining the physiological NMDA receptor's function and avoiding psychotropic adverse events. Although memantine has been the main treatment option for moderate and severe Alzheimer's disease in the last two decades, numerous studies have investigated its other potential uses. Some studies showed that memantine diminished chronic pain in complex regional pain syndrome, phantom limb pain, and fibromyalgia. Most in vivo and in vitro studies attributed the neuroprotective effects of memantine to the blockade of NMDA receptors on neurons as well as inhibition of microglia activation with subsequent reduction of pro-inflammatory mediators' production such as extracellular superoxide anion, intracellular ROS, nitric oxide, prostaglandin E2, and TNF-α, and stimulation of neurotrophic factor release from astroglia.
Up till now, no treatment options are available for prevention of PIPN. Several options have been investigated for treatment of CIPN with only duloxetine had proven benefits. Additional investigations are needed to develop preventive and ameliorative therapy of PIPN.
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Forty patients who will receive memantine 20 mg once daily in addition to weekly 80 mg/m2 of paclitaxel for 12 weeks.
Drug: Memantine-HCl
Forty patients who will receive placebo once daily in addition to weekly 80 mg/m2 of paclitaxel for 12 weeks.
Drug: Placebo Oral Tablet
Memantine hydrochloride 20 mg once daily for 12 weeks.
Also known as: Memantine 20 mg
A once daily matched tablet of placebo for 12 weeks
Also known as: Placebo comparator
Incidence and grading of paclitaxel induced peripheral neuropathy (PIPN)
Patients will be subjected to neurological examination every cycle to identify the presence and severity of PIPN. Grading of PIPN will be determined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5 published in November 2017 (NCI, 2017). The NCI-CTCAE grades the adverse events based on their severity on a 5-point scale where "Grade 1" is defined as: Mild or asymptomatic symptoms requiring clinical or diagnostic observations only; Intervention not indicated. "Grade 2": Moderate symptoms limiting age-appropriate ADL; minimal, local or noninvasive intervention is indicated. "Grade 3": Severe symptoms or medically significant but not life-threatening that are disabling or limiting self-care in ADL; hospitalization or prolongation of hospitalization is indicated. "Grade 4": Life threatening consequences; urgent or emergent intervention is needed. "Grade 5": Death related to adverse event. The primary outcome will be the difference i
Time frame: Weekly for 12 weeks.
Pain severity
Pain severity will be quantified using the Brief Pain Inventory Short Form (BPI-SF) (Cleeland and Ryan, 1994). It is widely used in both research and clinical settings. Patients will be asked to rate their pain on a numerical scale every cycle. Each scale is presented as a row of equidistant numbers from zero to ten, where zero indicates "no pain" and ten indicates "pain as bad as you can imagine".
Time frame: Weekly for 12 weeks.
Patients' QoL
Patients' QoL will be assessed through The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx) questionnaire. The Ntx subscale is a reliable and valid instrument for assessing the impact of neuropathy on QoL that demonstrates sensitivity to meaningful clinical distinctions and change over time. It is an eleven-item subscale that evaluates sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with CIPN for the previous 7 days. Each question in the Ntx subscale is represented by a Likert scale ranging from zero to four, where zero represents "not at all" and four represents "very much". The Ntx subscale generates a total score that is obtained by the summation of the composing question's scores. The total score ranges from 0 to 44 with higher scores indicating more severe neurotoxicity and worse QoL. The FACT/GOG-Ntx subscale will be evaluated at baseline, at 6 weeks, and 12 weeks.
Time frame: baseline, at 6 weeks, and 12 weeks.
Serum levels of nerve growth factor (NGF)
Nerve growth factor, one of major neurotrophins, is known to regulate the growth, maintenance, and survival of neurons. Clinical evidence supports that depletion of NGF occurs during the development of CIPN. In cancer patients receiving taxanes, serum levels of NGF levels were shown to decrease after four to six cycles and decline was associated with the severity of PIPN. For the determination of serum levels of NGF, a blood sample of 4 ml will be collected from every patient.
Time frame: Baseline and at 12 weeks.
Severity of depressive symptoms
The effect of memantine on depressive symptoms will be assessed through the nine-items Patient Health Questionnaire (PHQ-9). It is an easy-to-use self-administered questionnaire that reflects each of the nine criteria that the diagnosis of depression is based on according to the Diagnostic and Statistical Manual of Mental Disorders version V (DSM-V) criteria. The score for each question ranges from 0-3, as "0" (not at all) to "3" (nearly every day). The total score is obtained by adding up the individual items' scores. Scores range from 0 to 27 with scores from 0-4 indicating minimal depressive symptoms, 5-9: Mild, 10-14: Moderate, 15-19: Moderately severe, 20-27: Severe.
Time frame: Baseline, at 6 weeks, and 12 weeks.
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 12 months after the start.
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Studies of the drug tested here: Memantine