Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer
1 other identifier
observational
50
1 country
1
Brief Summary
Subgroups of patients with radically operated colorectal cancer can have a better prognosis by over six months are treated with chemotherapy. This beneficial effect may be enhanced somewhat by providing a combination of chemotherapy and the addition of oxaliplatin. It is known that this treatment additions increase the risk of neurotoxic side effects such as sensitivity to cold, numbness and tingling in hands or feet, muscle cramps, pain, taste disorders and swallowing difficulties. The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant chemotherapy experience neurotoxic effects and if the experience of the symptoms change over time during treatment and how symptoms affect patients' daily lives and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 16, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 7, 2016
September 1, 2016
2.7 years
January 16, 2015
September 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Oxaliplatin-Specific Neurotoxicity Scale
up to 12 months
Secondary Outcomes (2)
Health related quality of life (Fact-G) Questionnaire
up to 12 months
Sense of Coherence scale (SOC-scale)
up to 12 months
Interventions
Eligibility Criteria
Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
You may qualify if:
- Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
- Ability to answer questions in swedish language
- Ability to answer questions in mobile telephone
You may not qualify if:
- Colorectal cancer patients in other regimes (palliative setting, no surgery)
- Non ability to answer questions in swedish language
- Non ability to answer questions in mobile telephone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jenny Drottlead
Study Sites (1)
Jenny Drott
Linköping, 58183, Sweden
Related Publications (1)
Drott J, Fomichov V, Borjeson S, Bertero C. Sense of coherence and health-related quality of life in patients with neurotoxicity after cancer chemotherapy: Assessment from a real-time mobile phone-based system. Psychooncology. 2020 Jan;29(1):107-113. doi: 10.1002/pon.5243. Epub 2019 Oct 31.
PMID: 31670431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carina Bertero, RN,professor
Department of Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- RN, Ph-D student
Study Record Dates
First Submitted
January 16, 2015
First Posted
April 9, 2015
Study Start
January 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 7, 2016
Record last verified: 2016-09