Oxaliplatin Dose Modification for Colorectal Cancer Triggered by Patient Reported Toxicity: Acceptability and Effect on Chronic Chemotherapy Induced Peripheral Neuropathy

ABSTRACT: Interventions: The intervention involves a questionnaire that is given to patients prior to each cycle of chemotherapy which is given every 3 weeks as an outpatient at secondary hospital settings in the MidCentral Region. Patients will receive up to 8 cycles of chemotherapy. This questionnaire is a modified version of the NCI PRO-CTCAE neurotoxicity questions. It has been modified for use in this study by also incorporating questions regarding symptom duration and persistence of symptoms. The answers to the questions are then used by the treating clinician who is either the specialist medical oncologist or the training registrar under the supervision of the medical oncologist, to modify the Oxaliplatin dose according to a pre-specified guideline which is outlined in a flow-diagram. This guideline suggests the following modifications: * No numbness or tingling continue with same dose * Reported mild numbness and tingling triggers a 20-25% dose reduction in Oxaliplatin for the subsequent cycle * If a patient reports that mild numbness and tingling occurred on no more than or lasted for no longer than 3 days, the clinician has the option of continuing with the same dose of chemotherapy * If a patient reports persistent mild numbness and tingling present at the time of clinic, this triggers a hold” on Oxaliplatin and Capecitabine continues. If the numbness or tingling improves or remains mild at the subsequent pre-chemotherapy clinic, Oxaliplatin can be reintroduced with a 20-25% dose reduction * Reported moderate numbness and tingling triggers a hold” on Oxaliplatin for the subsequent cycle * Capecitabine chemotherapy continues, without Oxaliplatin * Assessment of numbness and tingling at the subsequent pre-chemotherapy clinic * If numbness and tingling is pr Primary outcome(s): Acceptability of the intervention defined by clinician compliance with the intervention - this will be measured as a percentage of individuals in which the intervention is implemented. This will be assessed using forms which are filled out by the clinician at clinic. The forms will ask what has the patient has recorded on their questionnaire, what modifications have been made to chemotherapy and if the intervention has not been followed, why this is. Acceptability requires that the intervention is implemented in at least 80% of individuals. [This is assessed at the completion of oxaliplatin chemotherapy, this being when the patient has stopped all oxaliplatin. Compliance is where the intervention has been followed throughout the chemotherapy course for an individual patient. The reason for completion of chemotherapy, ie. toxicity, progression, completed all intended cycles, will be captured on forms filled out by the clinician at clinic. ] Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Assignment: Single group;Type of endpoint: Safety/efficacy

DISEASE(S): Chemotherapy Induced Peripheral Neuropathy,Metastatic Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2464578 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR