Peripheral NeuropathyPhase 2NCT01523574
Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis
A Phase 2 study testing Vitamin E in people with Peripheral Neuropathy, run by Felipe Melo Cruz at 1 site in Brazil.
Trial summary
Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (PN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Vitamin E
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- ECOG Performance status 0 or 1
- Older than 18 years
- New diagnose with colorectal or gastric cancer
- Scheduled to receive oxaliplatin-based regimens
Who cannot join
- Excluded patients with a previous history of PN or with symptomatic PN at entry into the study
- Excluded patients who received other chemotherapy regimens (except isolated 5-fluorouracil)
- Patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis
Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine if vitamin E could also prevent Ox-induced acute PN
Read the detailed description
This was a prospective, phase II, randomized pilot study. Patients were randomized 5 days before the start of Ox to receive either vitamin E at 400 mg daily or placebo, until after the end of the Ox-based chemotherapy regimen. The investigators evaluated PN intensity using the CTCAE version 3 and specific Ox PN gradation scales. The investigators included patients with colorectal and gastric cancers scheduled to receive Ox-based chemotherapy. Both groups received calcium and magnesium supplements before and after oxaliplatin infusions.
- Conditions
- Peripheral Neuropathy
- Being tested
- Vitamin E, Placebo
- Keywords
- oxaliplatin, vitamin e, neuropathy, peripheral, prophylaxis
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Also called Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatin
Vitamin E 400mg PO orally
PlaceboDrug
Also called Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatin
Placebo, given orally
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily Receives: Drug: Placebo |
| Vitamin e | Experimental | Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily Receives: Drug: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
Measured: Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Felipe Melo Cruz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felipe Melo Cruz, Faculdade de Medicina do ABC
- Investigators
- Auro del Giglio, phD, Study director, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523574
- Sponsor's protocol ID
- VE01
- Status last verified
- Jan 2012
- First submitted
- 19 Dec 2011
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Afonseca SO, Cruz FM, Cubero Dde I, Lera AT, Schindler F, Okawara M, Souza LF, Rodrigues NP, Giglio Ad. Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial. Sao Paulo Med J. 2013;131(1):35-8. doi: 10.1590/s1516-31802013000100006.
PubMed 23538593
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis
- ClinicalTrials.gov ID
- NCT01523574
- Acronym / sponsor ID
- VE01
- Conditions
- Peripheral Neuropathy
- Keywords
- oxaliplatin, vitamin e, neuropathy, peripheral, prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Felipe Melo CruzUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine if vitamin E could also prevent Ox-induced acute PN
Detailed description
This was a prospective, phase II, randomized pilot study. Patients were randomized 5 days before the start of Ox to receive either vitamin E at 400 mg daily or placebo, until after the end of the Ox-based chemotherapy regimen. The investigators evaluated PN intensity using the CTCAE version 3 and specific Ox PN gradation scales. The investigators included patients with colorectal and gastric cancers scheduled to receive Ox-based chemotherapy. Both groups received calcium and magnesium supplements before and after oxaliplatin infusions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboFive days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily |
| Vitamin e | Experimental | Drug: Vitamin EFive days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECOG Performance status 0 or 1
- Older than 18 years
- New diagnose with colorectal or gastric cancer
- Scheduled to receive oxaliplatin-based regimens
Key exclusion criteria (3 listed)
- Excluded patients with a previous history of PN or with symptomatic PN at entry into the study
- Excluded patients who received other chemotherapy regimens (except isolated 5-fluorouracil)
- Patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins
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 |
|---|---|---|
| Vitamin EAlso: Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatinVitamin E 400mg PO orally | Drug | Vitamin e |
| PlaceboAlso: Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatinPlacebo, given orally | Drug | Control Group |
Primary outcome
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
Time frame: Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
- Derived from this study: PubMed 23538593Afonseca SO, Cruz FM, Cubero Dde I, Lera AT, Schindler F, Okawara M, Souza LF, Rodrigues NP, Giglio Ad. Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial. Sao Paulo Med J. 2013;131(1):35-8. doi: 10.1590/s1516-31802013000100006.
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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.
Auro del Giglio, phD study director
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin E in people with Peripheral Neuropathy, run by Felipe Melo Cruz at 1 site in Brazil.
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 4 inclusion and 3 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 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales. (time frame: Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)). 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 NCT01523574, which also lists 1 linked publication.
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 1 Feb 2012; AzTrials last refreshed its copy on 5 Nov 2026.