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Breast CancerPhase 3NCT00409071

Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.

A Phase 3 study testing Cocculine® in people with Breast Cancer, run by Centre Leon Berard at 1 site in France.

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

The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer. Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Cocculine®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
431 participants
Where
1 siteFrance
Study dates
Sep 2005to Oct 2008
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women with histologically proven non metastatic breast cancer
  • No previous chemotherapy
  • Treatment planning including 6 adjuvant CT courses with the first 3 being necessarily of the FAC50, FEC100 or TAC type
  • Age>= 18 years
  • ECOG performance status (PS) <= 2 (WHO scale)
  • Patient able to read and understand French
  • Written, voluntary, informed consent

Who cannot join

  • Previous treatment with chemotherapy (including neo-adjuvant chemotherapy for breast cancer)
  • Previous malignancies (except basal cell skin cancer or cervical cancer in situ or any other curatively treated malignancy in complete remission for more than 5 years)
  • Contraindication to corticosteroids or 5-HT3 receptor antagonists
  • Treatment with Cocculine® or any other anti-emetic drug in the 15 days before inclusion
  • Pregnant or lactating women
  • Follow-up impossible for social, geographical, familial or psychological reasons
  • Patients who cannot be contacted by phone

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Leon Berard

    Lyon, 69000

Other trials in France

About this study

Official title: Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.

Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.

The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.

Read the detailed description

The proportion of women with breast cancer treated by chemotherapy (CT) is increasing. CT-induced nausea and vomiting negatively impact patient quality of life.

The primary objective of the trial is to evaluate against a placebo the efficacy of Cocculine® administered as an adjunct to conventional treatments (corticosteroids and 5-HT3 receptor antagonists) for the management of nausea induced by a 1st course of adjuvant CT with FAC50, FEC100 or TAC in patients with non-metastatic breast cancer.

Secondary objectives are to test:

  • the persistence of Cocculine® efficacy over the 2nd and 3rd CT courses
  • the contribution of Cocculine® to the global management of nausea and vomiting during adjuvant CT
  • patient compliance with Cocculine® dose.

Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.

Conditions
Breast Cancer
Being tested
Cocculine®, placebo
Keywords
Non metastatic breast cancer, Adjuvant chemotherapy, Nausea, Vomiting, Quality of life, Homeopathy
Medical subject headings
Breast Neoplasms, Nausea, Vomiting

What participants receive

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

  • Cocculine®Drug

    12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.

  • placeboDrug

    12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.

Study groups in NCT00409071
Study groupRoleWhat they receive
1Experimentalcocculine
Receives: Drug: Cocculine®
2Placebo comparatorplacebo
Receives: Drug: placebo

What is being measured

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

  1. Score of "nausea" calculated using the FLIE questionnaire (Functional Living index for Emesis with 5-day recall)at the time of the 1rst adjuvant CT course

    Measured: The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.

Secondary outcomes (5)

  1. Score of "vomiting" and global score of "nausea + vomiting" calculated using the FLIE questionnaire at the time of the 1st, 2nd and 3rd adjuvant CT courses

    Measured: Nausea and vomiting items of FLIE questionnaire are completed by patients on the 6th day of the 1st, 2nd and 3rd adjuvant CT courses

  2. Score of "nausea" calculated using the FLIE questionnaire at the time of the 2nd and 3rd adjuvant CT courses

    Measured: Nausea items of FLIE questionnaire are completed by patients on the 6th day of the 2nd and 3rd adjuvant CT courses

  3. Patient autoevaluation (D1-D5) of nausea severity using a visual analogue scale and of the frequency of vomiting during the 1st, 2nd and 3rd adjuvant CT courses

    Measured: Visual analogue scale are completed by patients the 1st five days of the 1st, 2nd and 3rd adjuvant CT courses

  4. Rate of toxic effects (nausea and vomiting) recorded by investigators at the end of each of the 6 CT courses

    Measured: Recorded by investigators at the end of each of the 6 CT courses

  5. Evaluation of compliance: patient autoevaluation and counting of remaining tablets

    Measured: Patients register date and hour of tablets taking on a diary. Box remaining tablets will be count at the end of the 6 CT courses.

Timeline

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

  1. First posted8 Dec 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionOct 2008
  4. Study completionOct 2008

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00409071
Sponsor's protocol ID
COCCULINE
Other IDs
ET2005-028
Status last verified
Feb 2010
First submitted
7 Dec 2006
Last updated
5 Feb 2010
Results posted
No
Data monitoring committee
No

Publications

  • Pommier P, Gomez F, Sunyach MP, D'Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004 Apr 15;22(8):1447-53. doi: 10.1200/JCO.2004.07.063.

    PubMed 15084618

  • Perol D, Provencal J, Hardy-Bessard AC, Coeffic D, Jacquin JP, Agostini C, Bachelot T, Guastalla JP, Pivot X, Martin JP, Bajard A, Ray-Coquard I. Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial. BMC Cancer. 2012 Dec 17;12:603. doi: 10.1186/1471-2407-12-603.

    PubMed 23244208

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cocculine® in people with Breast Cancer, run by Centre Leon Berard at 1 site in France.

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 7 inclusion and 7 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 5 Feb 2010. 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 France. 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?

Score of "nausea" calculated using the FLIE questionnaire (Functional Living index for Emesis with 5-day recall)at the time of the 1rst adjuvant CT course (time frame: The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.). 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 NCT00409071, which also lists 2 linked publications.

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 5 Feb 2010.

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