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Garmin smartwatch / REBECCA Mobile application / Breast Neoplasms · Observational Study
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a withdrawn single-center prospective observational cohort study registered to examine risk factors, early detection methods, and quality-of-life impacts of paclitaxel-induced peripheral neuropathy in early-stage breast cancer. No results are posted in this registry record, and the study has been withdrawn; therefore, no evidence on efficacy or harm can be drawn.
Observational. Breast Neoplasms, Breast Cancer, Early-stage Breast Cancer, Non-Metastatic Breast Carcinoma, Polyneuropathy Due to Drugs, Polyneuropathy; Drug, Chemotherapy-in…; Female; age from 18 Years. Intervention: CIPN group; No-CIPN group. 1 site: Sweden.
This is a withdrawn single-center prospective observational cohort study registered to examine risk factors, early detection methods, and quality-of-life impacts of paclitaxel-induced peripheral neuropathy in early-stage breast cancer. No results are posted in this registry record, and the study has been withdrawn; therefore, no evidence on efficacy or harm can be drawn.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a withdrawn observational registry record with no posted results; it describes a planned study design and outcomes but contains no data to evaluate.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06052345). This is a study registration, not published results. Lead sponsor: Theodoros Foukakis. Recruitment status: WITHDRAWN. Study type: OBSERVATIONAL. Conditions: Breast Neoplasms, Breast Cancer, Early-stage Breast Cancer, Non-Metastatic Breast Carcinoma, Polyneuropathy Due to Drugs, Polyneuropathy; Drug, Chemotherapy-induced Peripheral Neuropathy, Quality of Life. Interventions: DEVICE: Garmin smartwatch; OTHER: REBECCA Mobile application; OTHER: REBECCA PC plug-in. Primary outcome measures: Correlation of significant deterioration in neurophysiological parameters including alterations in morphology of small fibers or reduced IENFD (Intraepidermal Nerve Fiber Density) on first follow up visit and development of CIPN , 1 year; Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN , 1 year; Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN , 1 year; Biochemical and metabolic abnormalities prior to paclitaxel treatment and their association with the development of CIPN , 1 year. Brief summary: This is a single center prospective observational cohort study that aims to: * examine and identify possible risk and susceptibility factors for the incidence and progression of chemotherapy-induced polyneuropathy (CIPN) in female patients primarily operated for early non-metastatic breast cancer who will receive adjuvant chemotherapy containing paclitaxel * test different neurophysiological methods for early detection of CIPN * explore changes that underlie the development of CIPN in relation to clinical presentations, neurophysiological assessment, including measures of small nerve fiber dysfunction, and possible biochemical, metabolic and genetic associations * explore the effects of CIPN in the patient's lifestyle and quality of life for up to 12 months after the initiation of treatment
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.