Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04560673 · ClinicalTrials.gov registry record · Phase 2
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
A Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 380
- Enrollment target
- 2
- Study locations
NCT04560673: Recruiting Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04560673 is a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 380 participants, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04560673, a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 380 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.
Primary Outcome
The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Duloxetine
- OTHER Questionnaire Administration
- BEHAVIORAL Neurofeedback
Study Locations (2)
Texas
- Harris Health System (LBJ) - Houston
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04560673 shows while recruiting
NCT04560673 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (67% lower).
The record links to 3 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04560673 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04560673 about?
NCT04560673 is a clinical study titled "Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy". This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help rel...
What is the current status of trial NCT04560673?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 380 participants. The study started on 2020-07-10. Estimated completion is 2026-12-31.
What conditions does trial NCT04560673 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Chemotherapy-induced Peripheral Neuropathy.
What interventions are being tested in trial NCT04560673?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Duloxetine (DRUG), Questionnaire Administration (OTHER), Neurofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT04560673?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04560673 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04560673's enrollment target sits among peer trials
380 42nd of 176 higher than 135 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or Latino/Latina Adolescent and Young Adult Childhood Cancer Survivors, Walking Juntos Study
RECRUITING · Phase 2
-
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
RECRUITING · Phase 2
-
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
RECRUITING · Phase 2
-
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
RECRUITING · Phase 2
-
Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas
RECRUITING · Phase 2
-
Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04777357 · 380 participants · Phase 3
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
- NCT04821154 · 380 participants
Persona Revision Knee System Outcomes
- NCT05102019 · 380 participants · NA
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
- NCT05511363 · 380 participants · Phase 3
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI