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Trial registered on ANZCTR


Registration number
ACTRN12611000078954
Ethics application status
Approved
Date submitted
19/01/2011
Date registered
21/01/2011
Date last updated
31/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot clinical trial assessing the efficacy and safety of supplementation with a B complex vitamin to reduce the incidence of chemotherapy induced peripheral neuropathy in patients diagnosed with a malignancy.
Scientific title
A pilot clinical trial assessing the efficacy and safety of supplementation with a B complex vitamin to reduce the incidence of chemotherapy induced peripheral neuropathy in patients diagnosed with a malignancy.
Secondary ID [1] 253449 0
TGA trial number: 2010/0651
Secondary ID [2] 253457 0
Protocol number: 2010000749
Universal Trial Number (UTN)
U1111-1119-1414
Trial acronym
CIPN - Chemotherapy induced peripheral neuropathy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy induced peripheral neuropathy 261000 0
Condition category
Condition code
Cancer 259133 259133 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral B group vitamin complex

a) the dose administered is 1 capsule twice a day equivalent to 100mg of B1, 1000mcg of B12, 1000mcg of folinic acid, 60mg of B6, 1000mcg of biotin, 327mg of B5, 200mcg of inositol, 200mg of B3, and 40mg of B2.

b) the duration administered is 36 weeks; and

c) administration begins 7 days prior to commencement of chemotherapy administration
Intervention code [1] 257891 0
Prevention
Comparator / control treatment
Placebo

a) The dose administered is 1 capsule twice a day of 0.700grams of microcrystalline celluose

b) the duration administered is 36 weeks; and

c) administration begins 7 days prior to commencement of chemotherapy administration
Control group
Placebo

Outcomes
Primary outcome [1] 261987 0
Total Neuropathy Score (TNS)
Timepoint [1] 261987 0
Tested T0, T12 or T24, T36 weeks from start of chemotherapy

Patients will be tested before chemotherapy (T0 weeks), at the end of their chemotherapy regime (T12 or T24 weeks) and at the end of the trial (T36 weeks)
Secondary outcome [1] 268916 0
EORTC Quality of Life Questionnaire
Timepoint [1] 268916 0
T0, T12, T24, T36 weeks
Secondary outcome [2] 268917 0
Brief Pain Inventory
Timepoint [2] 268917 0
T0, T12, T24, T36 weeks
Secondary outcome [3] 268918 0
Patient Neurotoxicity Questionnaire (PNQ)
Timepoint [3] 268918 0
T0, T12, T24, T36 weeks plus every second week for brief PNQ
Secondary outcome [4] 268919 0
Blood pathology for B vitamins (B1, B2, B6, B12, folate)
Timepoint [4] 268919 0
T0, T12 or T24

Patients will be tested before chemotherapy commences (T0), and at the end of their chemotherapy regime (T12 or T24 weeks).

Eligibility
Key inclusion criteria
1. Newly diagnosed with a neoplastic disease;
2. Have been prescribed chemotherapy treatment with paclitaxel, vincristine or oxaliplatin.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who will be prescribed any other concurrent investigational products
2. Currently experiences peripheral neuropathy
3. Have undergone chemotherapy treatment before with a neurotoxic agent
4. Have undergone chemotherapy treatment within the last five years
6. Women who are currently pregnancy or breast feeding
7. Any patient with established cognitive impairment, alcoholism, intellectual disability or severe mental illness
8. Any patient found to be deficient in vitamin B12 or folate after initial baseline blood pathology testing.
9. Any patients taking concurrent multivitamins, nutritional and herbal supplements or fish oils.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment will be through oncologists in Brisbane, Australia

Oncologist will send patient to investigators who will check inclusion and exclusion criteria.

Allocation will be blinded except for the statistician at the centre who will be doing the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Statisican will use a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3541 0
4103
Recruitment postcode(s) [2] 3542 0
4066
Recruitment postcode(s) [3] 3543 0
4102
Recruitment postcode(s) [4] 3544 0
4060
Recruitment postcode(s) [5] 3545 0
4059
Recruitment postcode(s) [6] 3546 0
4101
Recruitment postcode(s) [7] 3547 0
4000
Recruitment postcode(s) [8] 3548 0
4100
Recruitment postcode(s) [9] 3549 0
4150
Recruitment postcode(s) [10] 3550 0
4152
Recruitment postcode(s) [11] 3551 0
4064
Recruitment postcode(s) [12] 3552 0
4032
Recruitment postcode(s) [13] 3553 0
4030
Recruitment postcode(s) [14] 3554 0
4035
Recruitment postcode(s) [15] 3555 0
4011
Recruitment postcode(s) [16] 3556 0
4010
Recruitment postcode(s) [17] 3557 0
4121
Recruitment postcode(s) [18] 3558 0
4123
Recruitment postcode(s) [19] 3559 0
4122
Recruitment postcode(s) [20] 3560 0
4109
Recruitment postcode(s) [21] 3561 0
4121
Recruitment postcode(s) [22] 3562 0
4051
Recruitment postcode(s) [23] 3563 0
4052
Recruitment postcode(s) [24] 3564 0
4053
Recruitment postcode(s) [25] 3565 0
4050
Recruitment postcode(s) [26] 3566 0
4151
Recruitment postcode(s) [27] 3567 0
4152
Recruitment postcode(s) [28] 3568 0
4074
Recruitment postcode(s) [29] 3569 0
4073
Recruitment postcode(s) [30] 3570 0
4105
Recruitment postcode(s) [31] 3571 0
4104
Recruitment postcode(s) [32] 3572 0
4068
Recruitment postcode(s) [33] 3573 0
4069
Recruitment postcode(s) [34] 3574 0
4031
Recruitment postcode(s) [35] 3575 0
4035
Recruitment postcode(s) [36] 3576 0
4032
Recruitment postcode(s) [37] 3577 0
4005
Recruitment postcode(s) [38] 3578 0
4006
Recruitment postcode(s) [39] 3579 0
4003
Recruitment postcode(s) [40] 3580 0
4002
Recruitment postcode(s) [41] 3581 0
4171
Recruitment postcode(s) [42] 3582 0
4172
Recruitment postcode(s) [43] 3583 0
4173
Recruitment postcode(s) [44] 3584 0
4065
Recruitment postcode(s) [45] 3585 0
4012
Recruitment postcode(s) [46] 3586 0
4120

Funding & Sponsors
Funding source category [1] 258367 0
Self funded/Unfunded
Name [1] 258367 0
Address [1] 258367 0
Country [1] 258367 0
Primary sponsor type
University
Name
University of Queensland - Centre for Integrative Clinical and Molecular Medicine
Address
Level 2, R Wing
Princess Alexandra Hospital
Ipswich Road
Wooloongabba Qld 4103
Country
Australia
Secondary sponsor category [1] 257512 0
University
Name [1] 257512 0
University of Queensland - School of Medicine
Address [1] 257512 0
School of Medicine
St Lucia Campus
St Lucia Qld 4067
Country [1] 257512 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260337 0
The University of Queensland
Ethics committee address [1] 260337 0
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072
Ethics committee country [1] 260337 0
Australia
Date submitted for ethics approval [1] 260337 0
01/06/2010
Approval date [1] 260337 0
24/11/2010
Ethics approval number [1] 260337 0
2010000749
Ethics committee name [2] 260338 0
Metro South Human Research Ethics Committee
Ethics committee address [2] 260338 0
Centres for Research
Princess Alexandra Hospital
Metro South District
Ipswich Road
Wooloongabba Qld 4103
Ethics committee country [2] 260338 0
Australia
Date submitted for ethics approval [2] 260338 0
30/06/2010
Approval date [2] 260338 0
16/11/2010
Ethics approval number [2] 260338 0
HREC/10/QRAH/140

Summary
Brief summary
This study aims to determine whether vitamin B supplementation can reduce the incidence of chemotherapy induced peripheral neuropathy (nerve damage) in patients diagnosed with cancer.

Who is it for?
You can join this study if you have been recently diagnosed with cancer for which you have been prescribed chemotherapy treatment with the drug paclitaxel, vincristine or oxaliplatin.

Trial details
Participants will be randomly allocated to one of two groups. One group will take 2 capsules of vitamin B complex daily 1 week before chemotherapy treatment for 9 months. The other group will be given 2 capsules of a placebo (sugar capsule) to take daily for 9 months.

Patients will be assessed at three timepoints over the study duration to evaluate neuropathy, quality of life, pain, and levels of vitamin B in the blood.
Trial website
Trial related presentations / publications
1. ? Schloss J, Colosimo M, Linnane A, Masci P, Vitetta L. The Efficacy and Safety of B vitamin Supplementation in reducing the incidence of Chemotherapy Induced Peripheral Neuropathy in newly diagnosed patients. Australasian Integrative Medicine Association Conference Sept 3-5, 2010 – Abstract presentation

2. Schloss J, Colosimo M, Abraham R, Linnane A, Masci P, Vitetta L. The Efficacy and Safety of B Vitamins in Reducing Chemotherapy Induced Peripheral Neuropathy. The Princess Alexandra Hospital Health Symposium, Sept 8, 2011. Poster presentation

3. Schloss J, Colosimo M, Abraham R, Linnane A, Masci P, Vitetta L. The Efficacy and Safety of B Vitamins in Reducing Chemotherapy Induced Peripheral Neuropathy. The Australian Society for Medical Research Post Graduate Conference. May 31, 2011. Poster presentation.

4. Schloss J, Colosimo M, Abraham R, Linnane A, Masci P, Vitetta L. The Efficacy and Safety of B Vitamins in Reducing Chemotherapy Induced Peripheral Neuropathy. Ist International Conference on the Science of Nutrition Medicine Proceedings May 13-15, 2011. Page 104 – Abstract presentation

5. Schloss J, Colosimo M, Airey C, Masci PP, Liannane AW, Vitetta L. Nutraceuticals and Chemotherapy-induced peripheral neuropathy (CIPN): a Systematic review. Clin Nut 2013 Dec:32(6)888-93

6. Schloss J, Colosimo M, Linnane A, Masci P, Vitetta L. B vitamins status in cancer patients undergoing administration of chemotherapy.3rd International Conference on the Science of Nutrition Medicine Proceedings May 2013.

7. Schloss J, Vitetta L. Neuropathy (CIPN) and B vitamins. J ACNEM 2012, vol 31(2):24-28

Public notes

Contacts
Principal investigator
Name 32116 0
A/Prof Luis Vitetta
Address 32116 0
Level 5, TRI
The Princess Alexandra Hospital
Ipswich Road
Woolloongabba Queensland Australia 4102
Country 32116 0
Australia
Phone 32116 0
61 7 34437925
Fax 32116 0
Email 32116 0
l.vitetta@uq.edu.au
Contact person for public queries
Name 15363 0
Mrs Janet Schloss
Address 15363 0
Level 5, TRI
The Princess Alexandra Hospital
Ipswich Road
Woolloongabba Queensland Australia 4102
Country 15363 0
Australia
Phone 15363 0
61 7 34437925
Fax 15363 0
Email 15363 0
janet.schloss@uqconnect.edu.au
Contact person for scientific queries
Name 6291 0
A/Prof Luis Vitetta
Address 6291 0
Level 5, TRI
The Princess Alexandra Hospital
Ipswich Road
Woolloongabba Queensland Australia 4102
Country 6291 0
Australia
Phone 6291 0
61 402263316
Fax 6291 0
Email 6291 0
l.vitetta@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary