AzTrials
AzTrials

Breast CancerPhase 3NCT00661102

A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).

A Phase 3 study testing Corticosteroids, capecitabine [Xeloda] and dexpantenol [Bepantol] in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites in Brazil.

Completed

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

Official record
Search all trials

Trial summary

This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Corticosteroids, capecitabine [Xeloda] and dexpantenol [Bepantol]
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
598 participants
Where
35 sitesBrazil
Study dates
Dec 2008to Apr 2011
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

Who may be able to join

  • adult patients, >=18 years of age;
  • breast cancer or colorectal cancer patients;
  • treated with oral Xeloda for <=5 days;
  • lack of hand-foot syndrome (palmar-plantar erythrodysesthesia).

Who cannot join

  • existence of clinical symptoms suggesting hand-foot syndrome;
  • use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
  • diabetes mellitus.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Brazil35 sites

  • Study site

    Barretos, São Paulo, 14784-400

  • Study site

    Belo Horizonte, Minas Gerais, 30150-320

  • Study site

    Belo Horizonte, Minas Gerais, 31190-131

  • Study site

    Campinas, São Paulo, 13083-888

  • Study site

    Caxias do Sul, Rio Grande do Sul, 95020-170

  • Study site

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Study site

    Fortaleza, Ceará, 60336-550

  • Study site

    Goiânia, Goiás, 74605-020

  • Study site

    Goiânia, Goiás, 74605-070

  • Study site

    Ijuí, Rio Grande do Sul, 98700-000

  • Study site

    Itajaí, Santa Catarina, 88301-220

  • Study site

    Jaú, São Paulo, 17210-080

  • Study site

    Lajeado, Rio Grande do Sul, 95900-000

  • Study site

    Natal, Rio Grande do Norte, 59040150

  • Study site

    Niterói, Rio de Janeiro, 24033-900

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Ribeirão Preto, São Paulo, 14048-900

  • Study site

    Rio de Janeiro, Rio de Janeiro, 21020130

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22745-130

  • Study site

    Salvador, Estado de Bahia, 41810-570

  • Study site

    Salvador, Bahia, Estado de Bahia, 40170-380

  • Study site

    Santo André, São Paulo, 09060-650

  • Study site

    Santos, São Paulo, 11075-350

  • Study site

    Santos, São Paulo, 11075-900

  • Study site

    São José do Rio Preto, São Paulo, 15090-000

  • Study site

    São Paulo, São Paulo, 01221-020

  • Study site

    São Paulo, São Paulo, 04026-000

  • Study site

    São Paulo, São Paulo, 04039-901

  • Study site

    São Paulo, São Paulo, 22793-080

  • Study site

    Sorocaba, São Paulo, 18030-005

  • Study site

    Taguatinga, Federal District, 72115-700

  • Study site

    Teresina, Piauí, 90430-001

Other trials in Brazil

About this study

Official title: A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.

This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.

Conditions
Breast Cancer
Being tested
Corticosteroids, Placebo, capecitabine [Xeloda], dexpantenol [Bepantol]
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CorticosteroidsDrug

    As prescribed

  • PlaceboDrug

    As prescribed

  • capecitabine [Xeloda]Drug

    As prescribed

  • dexpantenol [Bepantol]Drug

    As prescribed

Study groups in NCT00661102
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: capecitabine [Xeloda]; Drug: dexpantenol [Bepantol]
2Active comparatorNot described
Receives: Drug: Corticosteroids; Drug: capecitabine [Xeloda]
3Placebo comparatorNot described
Receives: Drug: Placebo; Drug: capecitabine [Xeloda]

What is being measured

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

  1. Hand-foot syndrome onset

    Measured: Event driven

  2. QoL C-30 score

    Measured: Weeks 7, 13 and 17

Secondary outcomes (1)

  1. Adverse events

    Measured: Throughout study

Timeline

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

  1. First posted18 Apr 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

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
Treatment
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
598 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00661102
Sponsor's protocol ID
ML21419
Status last verified
Nov 2016
First submitted
16 Apr 2008
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Corticosteroids, capecitabine [Xeloda] and dexpantenol [Bepantol] in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites 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 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 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?

Hand-foot syndrome onset (time frame: Event driven). The study lists 2 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 NCT00661102.

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 2 Nov 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in