Trial · NCT07889115
Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
NCT07889115, Phase 2, Not yet recruiting, Al-Azhar University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients. Trials, record NCT07889115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07889115
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
- NCT number
- NCT07889115
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Al-Azhar University
- Conditions
- Breast Cancer, Peripheral Neuropathy Due to Chemotherapy, VAS Score
- Interventions
- Amantadine (oral)
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of PIPN | Weekly from base line to week 12 | All enrolled patients will receive education regarding the clinical manifestations of PIPN and will be encouraged to report any emerging symptoms. Additionally, a comprehensive neurological assessment will be conducted every cycle to evaluate the presence and severity of PIPN. The severity of PIPN will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5, published in November 2017 (NCI, 2017). The NCI-CTCAE classifies adverse events on a 5-point severity scale, as summarized in Table 1. Table 1. NCI-CTCAE v5.0 Grading Scale for Peripheral Neuropathy Grade Description Grade 1 Mild or asymptomatic symptoms necessitating clinical or diagnostic observation only; no intervention required. Grade 2 Moderate symptoms that limit age-appropriate activities of daily living (ADL); minimal, local, or noninvasive intervention is indicated. Grade 3 Severe or medically significant but not life-threatening symptoms th |
| Secondary | Time to Neuropathy | Weekly from base line to week12 | Time to neuropathy is defined as the interval from the initiation of paclitaxel therapy (first dose) to the first occurrence of Grade ≥ 2 PIPN, as determined by the NCI-CTCAE v5.0 criteria. This outcome reflects the duration for which the patient remains free from clinically significant neuropathy. Patients who do not develop Grade ≥ 2 PIPN by the end of the 12-week treatment period, or who withdraw from the study before developing this endpoint, will be censored at their last assessment visit. |
| Secondary | Change in Pain Intensity (vas) | Weekly from base line to week 12 | Pain intensity will be assessed using the Visual Analogue Scale (VAS), a unidimensional measure of pain intensity originally validated by Huskisson (1974). The VAS consists of a 100-mm horizontal line, where the left end represents "no pain" (0 mm) and the right end represents "worst imaginable pain" (100 mm). Patients will be asked to mark the point on the line that best reflects their current level of pain. The score is determined by measuring the distance in millimeters from the left anchor to the patient's mark. Figure 1. Visual Analogue Scale (VAS) for Pain Assessment No pain Worst imaginable pain 0 mm 100 mm The VAS will be administered at baseline and weekly during the 12-week treatment period. The change in VAS score from baseline to Week 12 will be calculated for each patient, with a reduction in score indicating an improvement in pain intensity |
| Secondary | Change in Patient Quality of Life | at Base line,week6,week12 | 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 (Calhoun et al., 2003) . 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 summation of the composing questions' scores. The total score ranges from 0 to 44 with higher scores indicating more severe neurotoxicity and worse QoL (HUANG et al., 2007) . The FACT/GOG-Ntx subscale will be evaluated at baseline, Week |
| Secondary | Change in serum NGF level | At base line and week12 | Nerve growth factor (NGF), one of the major neurotrophins, is known to regulate the growth, maintenance, and survival of neurons, and its signalling interacts closely with glutamatergic N-methyl-D-aspartate (NMDA) receptor pathways. Clinical evidence supports that depletion of NGF occurs during the development of CIPN. In cancer patients receiving taxanes, serum levels of NGF were shown to decrease after four to six cycles, and this decline was associated with the severity of PIPN (Rodwin et al., 2022; Youk et al., 2017) . Given that paclitaxel-induced NMDA receptor hyperactivation contributes to excitotoxicity and neurotrophic dysregulation, the NMDA-antagonistic effect of amantadine may help preserve endogenous NGF levels, thereby mitigating neurotoxicity. For determination of serum levels of NGF, a blood sample of 4 ml will be collected from every patient at baseline and at Week 12 (end of paclitaxel treatment) by means of a venous puncture and will be placed in gel vacutainer tub |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07889115
GET https://conductscience.org/api/trials/v1/NCT07889115/registered