Clinical Trial Details

OXTOX: Can Oxaliplatin neurotoxicity be reduced with ibudilast in people with metastatic colorectal cancer – a phase II randomised study

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Trial Information

Broad Health Condition Cancer
Neurological

Specific Health ConditionBowel - Back passage (rectum) or large bowel (colon)
Other neurological disorders

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Concord Repatriation Hospital - Concord
Royal North Shore Hospital - St Leonards
Wollongong Hospital - Wollongong
Orange Health Service - Orange
Nepean Hospital - Kingswood


Postcode
2139 - Concord
2065 - St Leonards
2500 - Wollongong
2800 - Orange
2747 - Kingswood

Anticipated date of first participant enrolment5/06/2019

Anticipated date of last participant enrolment5/06/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

Oxaliplatin chemotherapy improves survival but causes acute neuropathy (paraesthesias or dysesthesias) and chronic chemotherapy-induced peripheral neuropathy (CIPN) in almost all patients. CIPN can last for months to years, and can have a major impact on quality of life. It is suggested that ibudilast can prevent and treat this neurotoxicity.

The purpose of this study is to determine if ibudilast can safely and effectively decrease neurotoxicity in patients receiving chemotherapy. 

Who is it for?

You may be eligible for this study if you are an adult who has been diagnosed with metastatic colorectal cancer, and will be commencing chemotherapy with oxaliplatin. 

Study details

Participants in this study will continue with their prescribed chemotherapy. As part of this study, participants will be randomly allocated to one of two groups:
1. Ibudilast taken twice a day for the duration of oxaliplatin, and
2. Placebo capsules, taken twice a day for the same period. 
Participants will complete questionnaires and be examined by their usual oncologist.  Results of usual blood tests and imaging will be reviewed.
It is hoped that this research will help determine if ibudilast can be effective in reducing neurotoxicity in participants. If it is shown to be effective, it may allow more chemotherapy to be delivered, and therefore may improve survival rates in people with colorectal cancer. 
Eligibility

Key inclusion criteria

Diagnosis of histologically confirmed metastatic adenocarcinoma CRC who are to commence chemotherapy with oxaliplatin (i.e. FOLFOX or CAPOX).
Speak and read sufficient English to answer the questionnaires.
Adequate organ function, defined as renal function with glomerular filtration rate >50mL/min, adequate bone marrow (platelets>100 X 109 L-1, neutrophil count >1.5 X 109 L-1), and hepatic (<1.5 X the upper limit of normal (ULN), with the exception that GGT may be elevated <3 X ULN as long as bilirubin is within normal range).
Give written informed consent. 
Concomittant use of analgesics that are being used for purposes other than peripheral neuropathy but that have efficacy in neuropathy pain such as gabapentin and pregabalin and selective serotonin reuptake inhibitors (SSRIs), are allowed as long as the dose is expected to be consistent throughout the trial. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

ECOG Performance Status of 3 or above.
Existing peripheral neuropathy of any grade (e.g. due to diabetes mellitus, B12 deficiency, alcohol abuse, or use of nucleoside reverse transcriptase inhibitors).
Prior adjuvant treatment with oxaliplatin within the past 12 months; or any prior treatment with oxaliplatin for metastatic disease regardless of the time frame. 
Any major active psychiatric illness, dementia, or alcohol abuse that in the opinion of the principal investigator may interfere with their ability to complete neurotoxicity assessments.
Any contraindication to taking ibudilast, including uncontrolled nausea or vomiting with chemotherapy.
Inability to swallow capsules.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Gastro-Intestinal Trials Group
Primary Sponsor Address: GI Cancer Institute 143.119 Missenden Rd Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial websiteN/A

Trial IDACTRN12619000566134

UTNU1111-1231-0304

Contact person for information and recruitmentMrs
Corrinne Renton
Survivorship Research Group CeMPED: Centre for Medical Psychology & Evidence-based Decision-making Faculty of Medicine and Health The University of Sydney Camperdown, NSW 2006
+61 02 9036 5381

Further information iconcorrinne.renton@sydney.edu.au
Australia