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Trial record 12 of 531 for:    Taste Disorders

Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02412683
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jenny Drott, Linkoeping University

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.


Condition or disease Intervention/treatment
Colorectal Neoplasms Other: oxaliplatin

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin




Primary Outcome Measures :
  1. Oxaliplatin-Specific Neurotoxicity Scale [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Health related quality of life (Fact-G) Questionnaire [ Time Frame: up to 12 months ]
  2. Sense of Coherence scale (SOC-scale) [ Time Frame: up to 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
Criteria

Inclusion Criteria:

  • Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
  • Ability to answer questions in swedish language
  • Ability to answer questions in mobile telephone

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412683


Locations
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Sweden
Jenny Drott
Linkoping, Sweden, 58183
Sponsors and Collaborators
Jenny Drott
Investigators
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Study Director: Carina Bertero, RN,professor Department of Health Sciences

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Responsible Party: Jenny Drott, RN, Ph-D student, Linkoeping University
ClinicalTrials.gov Identifier: NCT02412683     History of Changes
Other Study ID Numbers: NTOX-123
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Oxaliplatin
Antineoplastic Agents