Clinical trial · Observational
Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy
An Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving Chemotherapy-induced peripherAl NeurOpathy in Patients With Colon or Breast Cancer After End of Adjuvant Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this observational study is to evaluate the effectiveness of the dietary supplementation "OnLife" in improving signs and symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in adult patients who have finished adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer). Furthermore, patient-reported outcomes (PROs) and concomitant medication used for the treatment of neuropathic pain will be assessed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIPN in Adjuvant Breast Cancer Patients | — | UNRESOLVED | — |
| CIPN in Adjuvant Colon Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OnLife | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Colon carcinoma
- description
- Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult colon cancer patients who experienced a CIPN after adjuvant oxaliplatin-containing chemotherapy.
- interventionNames
- Dietary Supplement: OnLife
- label
- Mamma carcinoma
- description
- Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult breast cancer patients who experienced a CIPN after adjuvant paclitaxel regimen.
- interventionNames
- Dietary Supplement: OnLife
Primary outcomes (1)
- measure
- Evaluation of the CIPN
- timeFrame
- 16 month
- description
- Incidence of grade 0/1/2/3/4 peripheral sensory and/ or motor neuropathy according to CTCAE v4.03 after end of adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with colon or breast cancer that have finished adjuvant oxaliplatin-containing or paclitaxel chemotherapy, respectively * End of adjuvant chemotherapy does not date back more than 4 months * Presence of CIPN grade 1-3 (according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03) * Decision for treatment with OnLife® (Baseline assessment has to be done before first intake of OnLife®) * Written informed consent * Able to understand and willing to complete study and patient-reported assessment instruments Exclusion Criteria: * Presence of sensory and/or motor disturbances due to other neurological diseases * Alcohol abuse * Pregnancy or breast-feeding * Severe difficulty swallowing * Intolerance to one of the ingredients of OnLife®
References
Publications (0)
Data not yet available