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Trial · NCT04276727

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryReduction in CIPN symptoms6 weeksA clinically significant reduction in pain (at least a 30% decrease in total BPI SF score as relates to the index neuropathic pain) between baseline and 6 weeks.
SecondaryTreatment effect on Chemotherapy Induced Peripheral Neuropathy6 weeksChanges in EORTC QLQ (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires) CIPN-20 (severity of 20 symptoms rated on 4 point scale from Not at all to Very much)
SecondaryTreatment effect on quality of life functions6 weeksChanges in EORTC QLC-c30 scores (30 symptoms on same scale as CIPN)
SecondaryTreatment effect on pain scores6 weeksChanges in Brief Pain Inventory - Short Form scores (13 symptoms rated from 0 None to 10 Worst)
SecondaryTreatment effect on anxiety and depression6 weeks (14 symptoms rated from 0 to 3 in severity)Changes in Hospital Anxiety and Depression Scale (HADS) scores
SecondaryTreatment effect on pain catastrophisation6 weeks (13 questions rated from 0-4 in severity)Changes in Pain Catastrophising Scale (PCS) scores
SecondaryTreatment effect on side effects6 weeksChanges in side effects (Yes/No to any SEs, description of SE to be given)
SecondaryTreatment effect on physical activity6 weeksChanges in Actigraph data (measures of step counts, amount of moderate/vigorous activity and sleep times/efficiency)
SecondaryPerceived effects of IMP6 weeksChanges in perceived effects questions (How long participant thinks treatment takes to take effect and how long it lasts for)
OtherChanges in Functional Magnetic Imaging data6 weeksChanges in FMRI data pre and post treatment
OtherPost treatment changes in CIPN12 weeks (from baseline)Changes in CIPN-20 scores (see secondary outcomes above for details of all questionnaire measures)
OtherPost treatment changes in quality of life measures12 weeks (from baseline)Changes in QLQ-c30
OtherPost treatment changes in pain scores12 weeks (from baseline)Changes in BPI-SF
OtherPost treatment changes in anxiety and depression12 weeks (from baseline)Changes in HADS scores
OtherPost treatment changes in pain catastrophising12 weeks (from baseline)Changes in PCS
OtherPost treatment changes in side effects12 weeks (from baseline)Changes in Side effects
OtherPost treatment changes in physical activity12 weeks (from baseline)Changes in Actigraph data
OtherChanges in sensory measures6 weeks and 12 weeks (from baseline)Changes in QST data

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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