CompletedNot Applicable

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

Germany150 participantsStarted 2016-11-22

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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®

What they're measuring

Evaluation of the CIPN

Timeframe: 16 month

Trial details

NCT IDNCT03065478

SponsorSwiss Medical Food AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-07

View on ClinicalTrials.gov More CIPN in Adjuvant Colon Cancer Patients trials