NCT03065478

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

February 16, 2017

Last Update Submit

September 5, 2018

Conditions

CIPN in Adjuvant Colon Cancer PatientsCIPN in Adjuvant Breast Cancer Patients

Keywords

Peripheral NeuropathyChemotherapy inducedCIPN

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the CIPN

    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)

    16 month

Secondary Outcomes (3)

  • Patient reported outcome: EORTC QLQ-C30

    16 month

  • Patient reported outcome: EORTC QLQ-CIPN20

    16 month

  • Concomitant medication used for the treatment of neuropathic pain

    16 month

Study Arms (2)

Colon carcinoma

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.

Dietary Supplement: OnLife

Mamma carcinoma

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult breast cancer patients who experienced a CIPN after adjuvant paclitaxel regimen.

Dietary Supplement: OnLife

Interventions

OnLifeDIETARY_SUPPLEMENT

Daily dosing of dietary supplement OnLife

Colon carcinomaMamma carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2 x 75 adult patients will be included. Cohort A: Adult patients with colon cancer who experience CIPN after end of adjuvant oxaliplatin-containing chemotherapy; Cohort B: Adult patients with breast cancer who experience CIPN after end of adjuvant paclitaxel chemotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Study Officials

  • Matthias Zaiss, Dr.

    Praxis für interdisziplinäre Onkologie & Hämatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 28, 2017

Study Start

November 22, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)