Dermatologic ComplicationsPhase 3NCT00486213
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer
A Phase 3 study testing pyridoxine hydrochloride in people with Dermatologic Complications and Palmar-plantar Erythrodysesthesia, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatologic Complications, Palmar-plantar Erythrodysesthesia, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- pyridoxine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2007to Aug 2014
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or palliative setting at a dose of ≥ 1000 mg/m² twice daily on days 1-14 (given in 3-week courses)
PATIENT CHARACTERISTICS:
- Life expectancy > 12 weeks
- No preexisting neuropathy
- No known allergy to pyridoxine hydrochloride and its incipients
- No other dermatologic condition that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior capecitabine
- Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab [Herceptin®] or bevacizumab) allowed provided they do not cause hand-foot syndrome (HFS)
- No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome) that can cause HFS
- No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy
- No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins or vitamin B complex)
- No concurrent over-the-counter products that contain urea or lactic acid
- No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride (e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or pyrazinamide)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.
PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome [HFS]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo.
Secondary
- Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
- Compare the quality of life changes in patients treated with these regimens.
- Identify factors predicting toxicity from capecitabine chemotherapy.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative setting). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning concurrently with planned capecitabine treatment, patients receive oral pyridoxine hydrochloride once daily on days 1-21.
- Arm II: Beginning concurrently with planned capecitabine treatment, patients receive oral placebo once daily on days 1-21.
In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of capecitabine treatment).
Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at the end of the study.
- Conditions
- Dermatologic Complications, Palmar-plantar Erythrodysesthesia, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- pyridoxine hydrochloride, Placebo
- Keywords
- dermatologic complications, chemotherapeutic agent toxicity, palmar-plantar erythrodysesthesia, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyridoxine hydrochlorideDietary supplement
Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Pyridoxine hydrochloride | Active comparator | Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle Receives: Dietary Supplement: pyridoxine hydrochloride |
| Placebo | Placebo comparator | Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
Measured: up to 8 cycles
Secondary outcomes (2)
Time to the onset of HFS ≥ grade 2
Measured: days to weeks
Quality of life as measured by EuroQOL (EQ-5D) questionnaire
Measured: QOL assessment at baseline, at beginning of cycles 2, 4, 6, 8 and at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Slow accrual
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 Dermatologic ComplicationsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoon-Sim Yap, FRACP, MBBS, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486213
- Sponsor's protocol ID
- CDR0000551757
- Other IDs
- SINGAPORE-06-22-OTH
- Status last verified
- Sep 2015
- First submitted
- 13 Jun 2007
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yap YS, Kwok LL, Syn N, Chay WY, Chia JWK, Tham CK, Wong NS, Lo SK, Dent RA, Tan S, Mok ZY, Koh KX, Toh HC, Koo WH, Loh M, Ng RCH, Choo SP, Soong RCT. Predictors of Hand-Foot Syndrome and Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269.
PubMed 28715540
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
- ClinicalTrials.gov ID
- NCT00486213
- Acronym / sponsor ID
- CDR0000551757
- Conditions
- Dermatologic Complications, Palmar-plantar Erythrodysesthesia, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- dermatologic complications, chemotherapeutic agent toxicity, palmar-plantar erythrodysesthesia, unspecified adult solid tumor, protocol specific
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 210 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Jun 2007 (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.
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.
PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome [HFS]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo.
Secondary
- Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
- Compare the quality of life changes in patients treated with these regimens.
- Identify factors predicting toxicity from capecitabine chemotherapy.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative setting). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning concurrently with planned capecitabine treatment, patients receive oral pyridoxine hydrochloride once daily on days 1-21.
- Arm II: Beginning concurrently with planned capecitabine treatment, patients receive oral placebo once daily on days 1-21.
In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of capecitabine treatment).
Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridoxine hydrochloride | Active comparator | Dietary Supplement: pyridoxine hydrochloridePyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle |
| Placebo | Placebo comparator | Other: PlaceboPyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| pyridoxine hydrochloridePyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle | Dietary supplement | Pyridoxine hydrochloride |
| Placebo | Other | Placebo |
Primary outcome
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
Time frame: up to 8 cycles
2 secondary outcomes
Time to the onset of HFS ≥ grade 2
Time frame: days to weeks
Quality of life as measured by EuroQOL (EQ-5D) questionnaire
Time frame: QOL assessment at baseline, at beginning of cycles 2, 4, 6, 8 and at the end of the study.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Derived from this study: PubMed 28715540Yap YS, Kwok LL, Syn N, Chay WY, Chia JWK, Tham CK, Wong NS, Lo SK, Dent RA, Tan S, Mok ZY, Koh KX, Toh HC, Koo WH, Loh M, Ng RCH, Choo SP, Soong RCT. Predictors of Hand-Foot Syndrome and Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269.
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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.
Yoon-Sim Yap, FRACP, MBBS principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pyridoxine hydrochloride in people with Dermatologic Complications and Palmar-plantar Erythrodysesthesia, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 24 Sep 2015. 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 Singapore. 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 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0 (time frame: up to 8 cycles). 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 NCT00486213, 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 24 Sep 2015.