Trial · NCT06551051
ADC-induced Neurotoxicity Treated With Duloxetine
NCT06551051, Phase 2, Unknown, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ADC-induced Neurotoxicity Treated With Duloxetine. Trials, record NCT06551051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06551051
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ADC-induced Neurotoxicity Treated With Duloxetine
- NCT number
- NCT06551051
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 37 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Solid Tumour
- Interventions
- duloxetine
- First posted
- 2024-08-13
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale | Day0 and Day36 | FACT-GOG-NTx scale neurotoxicity score (duloxetine treatment day 0 and 36) (4-point decrease in neurotoxicity score). The FACT-GOG-NTx scale, is a tool used to assess the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). This scale consists of 11 items, each item is scored on a 5-point scale (0=not at all, 4=very much), with a higher total score indicating more severe CIPN symptoms. In the study, the Minimal Clinically Important Difference (MCID) for the FACT-GOG-NTx scale was estimated to be between 1.38 and 3.68, which means that changes within this range are considered to be clinically meaningful. FACT/GOG-NTx provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 16 months | Adverse events (AEs), including type, incidence, grading (based on NCI-CTCAE V5.0 criteria), severity, duration, and relevance to the study medications. |
| Secondary | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale | 3 months | The FACT-GOG-NTx scale, is a tool used to assess the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). This scale consists of 11 items, each item is scored on a 5-point scale (0=not at all, 4=very much), with a higher total score indicating more severe CIPN symptoms. In the study, the Minimal Clinically Important Difference (MCID) for the FACT-GOG-NTx scale was estimated to be between 1.38 and 3.68, which means that changes within this range are considered to be clinically meaningful. FACT/GOG-NTx provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. |
| Secondary | Numerical rating scale | Day0 and Day36 | A numeric pain rating scale is a single-item question that asks the patient to rate his or her pain on a scale of 0 to 10, using the anchors of "no pain" and "worse pain imaginable." |
| Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Day0 and Day36 | Minimum Value: 0 (indicating the best possible health state) Maximum Value: 100 (indicating the worst possible health state) Higher scores indicate a worse quality of life or more severe symptoms. The scale includes both multi-item scales and single items to reflect various aspects of health-related quality of life. The scale consists of 30 questions measuring the patient's quality of life in terms of five functions (physical, daily living, cognitive, emotional and social), three symptoms (fatigue, pain, nausea and vomiting), and overall health, overall quality of life, and six other separate items (quality of sleep, appetite, diarrhoea, constipation, respiratory distress, and economic status). |
| Secondary | Neurotoxicity score assessed by CTCAE 5.0 scale | Day0 and Day36 | Grade 1: asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3: severe or medically significant but not immediately life threatening; hospitalisation or prolongation of existing hospitalisation indicated; disabling; limiting self care activities of daily living Grade 4: life threatening consequences; urgent intervention indicated |
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/NCT06551051
GET https://conductscience.org/api/trials/v1/NCT06551051/registered