A Phase 2 interventional study of Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy, sponsored by University Hospital, Clermont-Ferrand. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing dextromethorphan and placebo for the treatment of chemotherapy-induced peripheral neuropathy, assessed with a (0-10) numerical scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.
The influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
Drug: Dextromethorphan
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
Drug: Dextromethorphan
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
Measure of average pain intensity by a numerical rating scale
Time frame: 7 days before the visit at 1 month
Pain assessment by DN4
Time frame: at 1 month
total neuropathy score clinical version (TNSc)
Time frame: at 1 month
St Antoine questionnaire (QDSA)
Time frame: at 1 month
Evaluation of analgesic consumption
Time frame: at 1 month
Cognitive assessment by Trail Making Test A and B
Time frame: at 1 month
Cognitive assessment by Digit Symbol Substitution Test
Time frame: at 1 month
Cognitive assessment by FACT-COG test
Time frame: at 1 month
Cognitive assessment by Purdue Pegboard Test
Time frame: at 1 month
Quality of life assessment by EORTC QLQ-C30
Time frame: at 1 month
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Time frame: at 1 month
Quality of life assessment by Patient Global Impression of Change (PGIC)
Time frame: at 1 month
Anxiety and Depression assessment by HAD scale
Time frame: at 1 month
This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
University Hospital, Clermont-Ferrand