CancerPhase 3NCT00659269

A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients

A Phase 3 study testing Multivitamin (MV), Multivitamin + Vitamin B12 + Vitamin B6 and Chemotherapy in people with Cancer, run by New Mexico Cancer Research Alliance at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: Multivitamin (MV), Multivitamin + Vitamin B12 + Vitamin B6 and Chemotherapy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 319 participants
Where: 5 sitesUnited States
Study dates: Jul 2006to Jun 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients, 18 years of age or older, with a cancer treated with any of the following drugs are eligible:
Taxanes, vinca alkaloid analogs, heavy metals.
Each patient will be allocated to the following 3 groups:
Group 1 (Heavy metals): Patients treated with cisplatin (>25 mg/m2/week dose intensity) or oxaliplatin
Group 2 (Taxane): Patients treated with paclitaxel, docetaxel or abraxane
Group 3 (Vinca alkaloids): Patients treated with vincristine and vinorelbine.

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Patients must have a life expectancy of at least 24 weeks.
Patients must have a Zubrod performance status of 0-2.
Patients must sign an informed consent.
Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.

Who cannot join

Patients with symptomatic brain metastases are excluded from this study.
Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
Patients may receive no other concurrent complementary medicines during this study.
Patients with neuropathy induced diabetes are not eligible for this study
Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, 87102
Hematology Oncology Associates
Albuquerque, New Mexico, 87106
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505

Other trials in United States

About this study

Official title: A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.

Read the detailed description

Neuropathy can be a significant side effect of chemotherapy using platinum compounds, taxanes, and vinca alkaloids. There is clinical and preclinical data that vitamin B6 and B12 may alleviate neuropathy in experimentally induced neuropathy in animal models, or clinical neuropathy such as diabetic neuropathy. This is a randomized phase III study of the use of multivitamins with or without vitamin B6 and B12 to prevent or relieve neuropathic toxicity from chemotherapy in patients receiving chemotherapy. Patients will be stratified by type of chemotherapy agent (3 groups), presence or absence of neuropathy at baseline, and randomized to receive placebo or vitamin B6/B12 supplementation.

Conditions: Cancer
Being tested: Multivitamin (MV), Multivitamin + Vitamin B12 + Vitamin B6, Chemotherapy
Keywords: Vitamin B-12, Vitamin B-6, Chemotherapy-Induced Neuropathy, Taxanes, Vinca alkaloid, Heavy metals, Neuropathy, Nerve pain
Medical subject headings: Neoplasms, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multivitamin (MV)Dietary supplement
Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
Multivitamin + Vitamin B12 + Vitamin B6Dietary supplement
Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections
ChemotherapyDrug
Also called Cisplatin (Platinol, Platinol-AQ), Oxaliplatin (Eloxatin), Paclitaxel (Taxol, Abraxane), Docetaxel (Taxotere)
Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800

Study groups in NCT00659269
Study group	Role	What they receive
Multivitamin (MV)	Active comparator	1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts) Receives: Dietary Supplement: Multivitamin (MV); Drug: Chemotherapy
Multivitamin + Vitamin B12 + Vitamin B6	Experimental	1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts). The patient will also take the following, starting on the first day of chemotherapy: 1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts) 2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses. Receives: Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Neurotoxicity Assessment at Baseline
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.
Measured: At study start; prior to treatment (week 0)
Neurotoxicity Assessment at Cycle 2
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.
Measured: 2 weeks
Neurotoxicity Assessment at Cycle 4
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.
Measured: 4 weeks
Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Jun 2015

First posted16 Apr 2008 (estimated)
Study startJul 2006
Primary completionJun 2013
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 319 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00659269
Sponsor's protocol ID: INST 0553C
Other IDs: NCI-2012-00946
Status last verified: Jan 2016
First submitted: 14 Apr 2008
Last updated: 26 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.
ClinicalTrials.gov ID: NCT00659269
Acronym / sponsor ID: INST 0553C
Conditions: Cancer
Keywords: Vitamin B-12, Vitamin B-6, Chemotherapy-Induced Neuropathy, Taxanes, Vinca alkaloid, Heavy metals, Neuropathy, Nerve pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 319 participants (actual)
Lead sponsor: New Mexico Cancer Research AllianceUniversity, hospital or other
Study start: Jul 2006
Primary completion: Jun 2013 (actual)
Study completion: Jun 2015 (actual)
First posted: 16 Apr 2008 (estimated)
Results: Posted 25 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Multivitamin (MV)	Active comparator	Dietary Supplement: Multivitamin (MV), Drug: Chemotherapy1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
Multivitamin + Vitamin B12 + Vitamin B6	Experimental	Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6, Drug: Chemotherapy1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts). The patient will also take the following, starting on the first day of chemotherapy: 1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts) 2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

All patients, 18 years of age or older, with a cancer treated with any of the following drugs are eligible:
Patients must have a life expectancy of at least 24 weeks.
Patients must have a Zubrod performance status of 0-2.
Patients must sign an informed consent.
Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.

Key exclusion criteria (5 listed)

Patients with symptomatic brain metastases are excluded from this study.
Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
Patients may receive no other concurrent complementary medicines during this study.
Patients with neuropathy induced diabetes are not eligible for this study
Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multivitamin (MV)Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.	Dietary supplement	Multivitamin (MV)
Multivitamin + Vitamin B12 + Vitamin B6Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections	Dietary supplement	Multivitamin + Vitamin B12 + Vitamin B6
ChemotherapyAlso: Cisplatin (Platinol, Platinol-AQ), Oxaliplatin (Eloxatin), Paclitaxel (Taxol, Abraxane), Docetaxel (Taxotere)Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine) Ranges of cumulative doses (in mg/m2) are: paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800	Drug	Multivitamin (MV), Multivitamin + Vitamin B12 + Vitamin B6

Primary outcome

Neurotoxicity Assessment at Baseline
Time frame: At study start; prior to treatment (week 0)
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.
Neurotoxicity Assessment at Cycle 2
Time frame: 2 weeks
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.
Neurotoxicity Assessment at Cycle 4
Time frame: 4 weeks
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.
Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
Time frame: 4 weeks
Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.

Results and safety

Results posted to the registry on 25 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multivitamin (MV)	157	156
Multivitamin + Vitamin B12 + Vitamin B6	162	161

Primary outcome: Neurotoxicity Assessment at Baseline

Time frame: At study start; prior to treatment (week 0). Mean (Standard Deviation). Unit: units on a scale

Measure	Taxane Group: Multivitamin (MV) Arm n = 84	Taxane Group: MV + Vitamin B12 + Vitamin B6 n = 86	Heavy Metals Group: Multivitamin (MV) Arm n = 48	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n = 45	Vinca Alkaloids Group: Multivitamin (MV) Arm n = 10	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n = 12
Value	8.5 (8.5)	7.3 (7.3)	5.23 (5.86)	4.58 (5.34)	6.80 (5.09)	2.08 (2.02)

Population analysed: Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)

Primary outcome: Neurotoxicity Assessment at Cycle 2

Time frame: 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Taxane Group: Multivitamin (MV) Arm n = 72	Taxane Group: MV + Vitamin B12 + Vitamin B6 n = 80	Heavy Metals Group: Multivitamin (MV) Arm n = 27	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n = 25	Vinca Alkaloids Group: Multivitamin (MV) Arm n = 9	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n = 10
Value	13.0 (10.9)	12.0 (9.9)	9.7 (5.99)	8.4 (7.16)	14.56 (12.9)	5.6 (6.59)

Population analysed: Of the 92 \& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 \& 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 \& 25 patients in Group 2 (Heavy Metals) and 9 \& 10 patients in Group 3 (Vinca)

Primary outcome: Neurotoxicity Assessment at Cycle 4

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Taxane Group: Multivitamin (MV) Arm n = 67	Multivitamin + Vitamin B12 + Vitamin B6 n = 58	Heavy Metals Group: Multivitamin (MV) Arm n = 28	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n = 21	Vinca Alkaloids Group: Multivitamin (MV) Arm n = 6	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n = 9
Value	14.5 (11.4)	14.5 (11.1)	8.71 (6.5)	7.05 (6.55)	17.5 (5.36)	9.22 (10.22)

Population analysed: Of the 92 \& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 \& 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 \& 21 patients in Group 2 (Heavy Metals) and 6 \& 9 patients in Group 3 (Vinca)

Primary outcome: Change in Neurotoxicity Assessment Between Cycle 4 and Baseline

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Taxane Group: Multivitamin (MV) Arm n = 54	Taxane Group: MV + Vitamin B12 + Vitamin B6 n = 62	Heavy Metals Group: Multivitamin (MV) Arm n = 28	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n = 20	Vinca Alkaloids Group: Multivitamin (MV) Arm n = 5	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n = 9
Value	7.0 (9.9)	7.2 (9.8)	3.9 (7.1)	4.7 (5.7)	11.8 (4.7)	7 (9.2)

Taxane Group: Multivitamin (MV) Arm vs Taxane Group: MV + Vitamin B12 + Vitamin B6: p = 0.91, ANOVA

Population analysed: Of the 92 \& 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 \& 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 \& 20 patients in Group 2 (Heavy Metals) and 5 \& 9 patients in Group 3 (Vinca)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multivitamin (MV)	0 of 157 (0%)	0 of 0	Not reported
Multivitamin + Vitamin B12 + Vitamin B6	0 of 162 (0%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): The number of completed surveys decreased as time went on for each group of patients. This resulted in small numbers of patients to analyze, especially in Group 3 (Vinca Alkaloids), since there weren't many patients in this group to begin with.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
New Mexico Cancer Care AllianceLink provided by the sponsor.
University of New Mexico Cancer CenterLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zoneddy Dayao, MD principal investigator

UNM Cancer Center

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Multivitamin (MV), Multivitamin + Vitamin B12 + Vitamin B6 and Chemotherapy in people with Cancer, run by New Mexico Cancer Research Alliance at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurotoxicity Assessment at Baseline (time frame: At study start; prior to treatment (week 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00659269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.