Breast CancerPhase 4NCT01049295
Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer
A Phase 4 study testing oil fish and corn oil pearls in people with Breast Cancer, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast cancer. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- oil fish and corn oil pearls
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIran
- Study dates
- Apr 2010to Feb 2012
- Phase
- Phase 4
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffering from invasive breast cancer,not receiving any form of supplementations and oil fish
Who cannot join
- Suffering from the diseases leading to neuropathy, e.g.diabetes, hyperthyroidism, AIDS and primary neural diseases
- Suffering from any other kind of malignancies
- Receiving any chemotherapeutical agents in the past
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
: Tehran University of Medical Sciences, School of Public Health
Tehran, Tehran Province
Zohreh Ghoreishi, Ph.D student, 0098 912 7390799, zghoreishi@razi.tums.ac.ir
seyed Ali Keshavarz, professor, 0098 912 1279306, s_akeshavarz@yahoo.com
About this study
Official title: The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast cancer.
Read the detailed description
Breast cancer is the most common malignancy in women. Chemotherapy with taxanes in patients with breast cancer causes some complications and neuropathy is one of the most frequent that is dose limiting and even may cause to stop the therapy. n-3 fatty acids have very significant role in improvement the function of the neurons.n-3 fatty acids decrease the demyelination and toxicities resulting from taxanes. They also lower the level of of the neurotoxic inflammatory agents. So,n-3 fatty acids improve the quality of life in this patients. 52 patients with invasive breast cancer will be randomized in a double-blind placebo-controlled manner to receive either 640 mg oil fish pearls( 54% DHA, 10% EPA) 3 times a day or placebo( corn oil pearls) for 3 months(during the chemotherapy with taxanes). Neuropathy (using EMG-NCV test)and the level of IL-1,IL-6, TNF-alpha, hs-crp and serum level of EPA and DHA fatty acids will be measured before chemotherapy with taxanes and at the end of the therapy (after 3 months).
- Conditions
- Breast Cancer
- Being tested
- oil fish, corn oil pearls
- Keywords
- taxanes, breast cancer, n3 fatty acids, inflammation
- Medical subject headings
- Breast Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oil fishDietary supplement
Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day
corn oil pearlsOther
corn oil pearls 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| oil fish pearls | Experimental | patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day Receives: Dietary Supplement: oil fish |
| placebo | Placebo comparator | patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day Receives: Other: corn oil pearls |
What is being measured
The primary outcome is the main question the study is designed to answer.
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP
Measured: first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy
Secondary outcomes (1)
The serum level of DHA and EPA fatty acids
Measured: first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011 (estimated)
- Study completionFeb 2012 (estimated)
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 Breast 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohreh Ghoreishi, Tehran University of Medical Sciences
- Investigators
- Seyed Ali Keshavarz, professor, Principal investigator, Tehran University of Medical SciencesZohreh Ghoreishi, Ph.D student, Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049295
- Sponsor's protocol ID
- 88-04-27-9683
- Status last verified
- Apr 2011
- First submitted
- 13 Jan 2010
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ghoreishi Z, Esfahani A, Djazayeri A, Djalali M, Golestan B, Ayromlou H, Hashemzade S, Asghari Jafarabadi M, Montazeri V, Keshavarz SA, Darabi M. Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: a randomized double-blind placebo controlled trial. BMC Cancer. 2012 Aug 15;12:355. doi: 10.1186/1471-2407-12-355.
PubMed 22894640
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT01049295
- Acronym / sponsor ID
- 88-04-27-9683
- Conditions
- Breast Cancer
- Keywords
- taxanes, breast cancer, n3 fatty acids, inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 14 Jan 2010 (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.
The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast cancer.
Detailed description
Breast cancer is the most common malignancy in women. Chemotherapy with taxanes in patients with breast cancer causes some complications and neuropathy is one of the most frequent that is dose limiting and even may cause to stop the therapy. n-3 fatty acids have very significant role in improvement the function of the neurons.n-3 fatty acids decrease the demyelination and toxicities resulting from taxanes. They also lower the level of of the neurotoxic inflammatory agents. So,n-3 fatty acids improve the quality of life in this patients. 52 patients with invasive breast cancer will be randomized in a double-blind placebo-controlled manner to receive either 640 mg oil fish pearls( 54% DHA, 10% EPA) 3 times a day or placebo( corn oil pearls) for 3 months(during the chemotherapy with taxanes). Neuropathy (using EMG-NCV test)and the level of IL-1,IL-6, TNF-alpha, hs-crp and serum level of EPA and DHA fatty acids will be measured before chemotherapy with taxanes and at the end of the therapy (after 3 months).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oil fish pearls | Experimental | Dietary Supplement: oil fishpatients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day |
| placebo | Placebo comparator | Other: corn oil pearlspatient with invasive breast cancer who received corn oil pearls as placebo 3 times a day |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suffering from invasive breast cancer,not receiving any form of supplementations and oil fish
Key exclusion criteria (3 listed)
- Suffering from the diseases leading to neuropathy, e.g.diabetes, hyperthyroidism, AIDS and primary neural diseases
- Suffering from any other kind of malignancies
- Receiving any chemotherapeutical agents in the past
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 |
|---|---|---|
| oil fishActive Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day | Dietary supplement | oil fish pearls |
| corn oil pearlscorn oil pearls 3 times a day | Other | placebo |
Primary outcome
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP
Time frame: first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy
1 secondary outcome
The serum level of DHA and EPA fatty acids
Time frame: first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
- Derived from this study: PubMed 22894640Ghoreishi Z, Esfahani A, Djazayeri A, Djalali M, Golestan B, Ayromlou H, Hashemzade S, Asghari Jafarabadi M, Montazeri V, Keshavarz SA, Darabi M. Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: a randomized double-blind placebo controlled trial. BMC Cancer. 2012 Aug 15;12:355. doi: 10.1186/1471-2407-12-355.
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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.
Seyed Ali Keshavarz, professor principal investigator
Tehran University of Medical Sciences
Zohreh Ghoreishi, Ph.D student study director
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oil fish and corn oil pearls in people with Breast Cancer, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Nov 2011. 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 Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zohreh Ghoreishi, Ph.D student (0098 912 7390799, zghoreishi@razi.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP (time frame: first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy). 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 NCT01049295, 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 Nov 2011.