Breast CancerNCT01821833
Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel
A study testing Omega-3 fatty acid and Paclitaxel in people with Breast Cancer and Ovarian Neoplasm, run by New Mexico Cancer Research Alliance at 2 sites in United States.
Trial summary
Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side effects including neuropathy (weakness, numbness and pain) and generalized body aches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Neoplasm, Pain
- What is being tested?
- Omega-3 fatty acid and Paclitaxel
- 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2016to 3 Aug 2022
- Phase
- Interventional
- 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
- Patients have a diagnosis of breast cancer or ovarian cancer
- Patients are scheduled to receive weekly paclitaxel at 70-90 mg/m^2 for a minimum of 2 months; 3 out of 4 weeks is allowed
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- Patients must not have taken omega-3-fatty acid supplements within the past 1 month prior to registration and must agree to refrain from use of omega- 3 fatty acid supplements from sources outside the study
- Patients must not be on nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin for at least 1 week prior to registration; NSAIDS or aspirin are allowed after enrollment
- Patients must not have received any other analgesics (opiates and tramadol) 1 week prior to registration; analgesics (opiates and tramadol) are allowed after enrollment
Show all 10Show fewer
- Patients must have the ability to complete questionnaires by themselves or with assistance
- Patients must not be on anticoagulation medication (heparin/ warfarin) within 28 days prior to registration, because of increased risk of bleeding
- Concurrent treatment with carboplatin +/- bevacizumab is allowed
- Concurrent treatment with human epidermal growth factor receptor (Her2 neu) targeted therapy is allowed
Who cannot join
- Known allergy to omega 3 fatty acids, fish or shellfish
- Pre-existing diagnosis of peripheral neuropathy
- Diagnosis of fibromyalgia
- Concurrent planned neutrophil colony stimulating factor therapy
- Prior exposure to paclitaxel within the last 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87106
Presbyterian Medical Group
Albuquerque, New Mexico, 87110
About this study
Official title: A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome
Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side effects including neuropathy (weakness, numbness and pain) and generalized body aches. The latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and often occurs in the first three to four days after administration. It affects about 58-90% of patients. Currently, the mechanism of P-APS is unknown, and there is no standard of care to treat it. However, an intervention with both anti-inflammatory as well as neuroprotective properties would be an ideal candidate for testing in the prevention of P-APS and subsequent development of peripheral neuropathy. Previous studies have suggested that omega-3 fatty acids may act as neuroprotective agents, and there are no currently documented safety concerns with their combined use with paclitaxel.
Therefore, this randomized pilot clinical trial will determine whether omega-3 fatty acids can treat pain in patients with breast or ovarian cancer receiving paclitaxel.
Read the detailed description
One mechanism proposed for P-APS is an early inflammatory process characterized by macrophage activation in both the dorsal root ganglia and peripheral nerve occurring shortly after paclitaxel therapy. Morphologic alterations in DRG satellite cells have been noted and upregulation of proinflammatory cytokines have been hypothesized as early events in the development of neuropathy. Therefore, it is possible that paclitaxel-induced neuropathic pain may be mediated by pro-inflammatory cytokines. If P-APS and chronic neuropathy are indeed part of a continuum, the inflammatory pathway would be a reasonable target for therapy. While the mechanism of how paclitaxel leads to the development of neuropathy is still not understood, it has been hypothesized that its microtubule-stabilizing effects disrupt axonal transport. Intervention with an agent that is both anti-inflammatory as well as neuroprotective is therefore worth exploring.
Long chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are common dietary supplements. They have well established anti-inflammatory properties which serve as the basis for their use in therapeutic trials in inflammatory conditions. Omega -3 fatty acids consumption can attenuate the production of pro-inflammatory metabolites. In addition, it can generate local mediators that facilitate resolution of inflammation. Thus, if P-APS is indeed mediated by inflammation, the anti-inflammatory activity of omega 3 fatty acids may be one mechanism to prevent P-APS. Additionally, given its well established safety profile, it may be an attractive alternative to NSAIDS.
A dose of at least 2.7 g/day of EPA and DHA have been reported to have analgesic effects in inflammatory conditions. The dose of 4 g/day is an FDA-approved dose of omega 3 fatty acids (Lovaza) for the treatment of hypertriglyceridemia and has a well-documented toxicity profile. On the basis of this, a dose of 4 g/day was selected for this study. Lovaza (omega-3-acid ethyl esters) capsules will be used. Each 1-gram capsule contains approximately 465 mg EPA and 375 mg DHA.
- Conditions
- Breast Cancer, Ovarian Neoplasm, Pain
- Being tested
- Omega-3 fatty acid, Placebo, Paclitaxel
- Keywords
- omega-3, fatty acids, paclitaxel, acute pain syndrome, peripheral neuropathy, chemotherapy induced neuropathy
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Pain, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDietary supplement
Also called Fish oil, n-3 fatty acid, O3FA, Lovaza
Patients receive omega-3 fatty acid capsules orally beginning 1 week prior to paclitaxel treatment.
Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first).
Each 1-gram capsule contains approximately 465 mg eicosapentaenoic acid (EPA) and 375 mg docosahexaenoic acid (DHA).
PlaceboDietary supplement
Patients receive placebo capsules orally beginning 1 week prior to paclitaxel treatment.
Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first)
PaclitaxelDrug
Also called Taxol
Patients will receive, as part of their standard of care, weekly paclitaxel at 70 to 90 mg/m2 intravenously for a minimum of 2 months. Treatment 3 out of 4 weeks is allowed.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Omega-3 fatty acid) | Experimental | Four Omega-3 fatty acid capsules (at 1 gram/capsule) are administered orally daily.
The capsules may be administered either once daily or as 2 capsules two times daily. Receives: Dietary Supplement: Omega-3 fatty acid; Drug: Paclitaxel |
| Arm II (placebo) | Placebo comparator | Four placebo capsules (at 1 gram microcrystalline cellulose/capsule) are administered orally daily.
The capsules may be administered either once daily or as 2 capsules two times daily. Receives: Dietary Supplement: Placebo; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean severity of pain
Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.
Measured: Up to 1 month after completion of therapy
Secondary outcomes (1)
Incidence of pain or relief
Fisher's exact test will be used for the incidence variable with 95% confidence intervals.
Measured: Up to 1 month after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study start24 May 2016
- Primary completion16 Jan 2018
- Study completion3 Aug 2022
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance Healthcare Foundation
- Responsible party
- Sponsor
- Investigators
- Zoneddy Dayao, Principal investigator, University of New Mexico Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821833
- Sponsor's protocol ID
- INST 1211
- Other IDs
- NCI-2013-00443
- Status last verified
- Oct 2022
- First submitted
- 27 Mar 2013
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tawfik B, Dayao ZR, Brown-Glaberman UA, Pankratz VS, Lafky JM, Loprinzi CL, Barton DL. A pilot randomized, placebo-controlled, double-blind study of omega-3 fatty acids to prevent paclitaxel-associated acute pain syndrome in breast cancer patients: Alliance A22_Pilot2. Support Care Cancer. 2023 Oct 17;31(12):637. doi: 10.1007/s00520-023-08082-x.
PubMed 37847317
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome
- ClinicalTrials.gov ID
- NCT01821833
- Acronym / sponsor ID
- INST 1211
- Conditions
- Breast Cancer, Ovarian Neoplasm, Pain
- Keywords
- omega-3, fatty acids, paclitaxel, acute pain syndrome, peripheral neuropathy, chemotherapy induced neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Collaborators
- Alliance Healthcare Foundation
- Study start
- 24 May 2016 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 1 Apr 2013 (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.
Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side effects including neuropathy (weakness, numbness and pain) and generalized body aches. The latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and often occurs in the first three to four days after administration. It affects about 58-90% of patients. Currently, the mechanism of P-APS is unknown, and there is no standard of care to treat it. However, an intervention with both anti-inflammatory as well as neuroprotective properties would be an ideal candidate for testing in the prevention of P-APS and subsequent development of peripheral neuropathy. Previous studies have suggested that omega-3 fatty acids may act as neuroprotective agents, and there are no currently documented safety concerns with their combined use with paclitaxel.
Therefore, this randomized pilot clinical trial will determine whether omega-3 fatty acids can treat pain in patients with breast or ovarian cancer receiving paclitaxel.
Detailed description
One mechanism proposed for P-APS is an early inflammatory process characterized by macrophage activation in both the dorsal root ganglia and peripheral nerve occurring shortly after paclitaxel therapy. Morphologic alterations in DRG satellite cells have been noted and upregulation of proinflammatory cytokines have been hypothesized as early events in the development of neuropathy. Therefore, it is possible that paclitaxel-induced neuropathic pain may be mediated by pro-inflammatory cytokines. If P-APS and chronic neuropathy are indeed part of a continuum, the inflammatory pathway would be a reasonable target for therapy. While the mechanism of how paclitaxel leads to the development of neuropathy is still not understood, it has been hypothesized that its microtubule-stabilizing effects disrupt axonal transport. Intervention with an agent that is both anti-inflammatory as well as neuroprotective is therefore worth exploring.
Long chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are common dietary supplements. They have well established anti-inflammatory properties which serve as the basis for their use in therapeutic trials in inflammatory conditions. Omega -3 fatty acids consumption can attenuate the production of pro-inflammatory metabolites. In addition, it can generate local mediators that facilitate resolution of inflammation. Thus, if P-APS is indeed mediated by inflammation, the anti-inflammatory activity of omega 3 fatty acids may be one mechanism to prevent P-APS. Additionally, given its well established safety profile, it may be an attractive alternative to NSAIDS.
A dose of at least 2.7 g/day of EPA and DHA have been reported to have analgesic effects in inflammatory conditions. The dose of 4 g/day is an FDA-approved dose of omega 3 fatty acids (Lovaza) for the treatment of hypertriglyceridemia and has a well-documented toxicity profile. On the basis of this, a dose of 4 g/day was selected for this study. Lovaza (omega-3-acid ethyl esters) capsules will be used. Each 1-gram capsule contains approximately 465 mg EPA and 375 mg DHA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Omega-3 fatty acid) | Experimental | Dietary Supplement: Omega-3 fatty acid, Drug: PaclitaxelFour Omega-3 fatty acid capsules (at 1 gram/capsule) are administered orally daily. The capsules may be administered either once daily or as 2 capsules two times daily. |
| Arm II (placebo) | Placebo comparator | Dietary Supplement: Placebo, Drug: PaclitaxelFour placebo capsules (at 1 gram microcrystalline cellulose/capsule) are administered orally daily. The capsules may be administered either once daily or as 2 capsules two times daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients have a diagnosis of breast cancer or ovarian cancer
- Patients are scheduled to receive weekly paclitaxel at 70-90 mg/m^2 for a minimum of 2 months; 3 out of 4 weeks is allowed
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- Patients must not have taken omega-3-fatty acid supplements within the past 1 month prior to registration and must agree to refrain from use of omega- 3 fatty acid supplements from sources outside the study
- Patients must not be on nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin for at least 1 week prior to registration; NSAIDS or aspirin are allowed after enrollment
Key exclusion criteria (5 listed)
- Known allergy to omega 3 fatty acids, fish or shellfish
- Pre-existing diagnosis of peripheral neuropathy
- Diagnosis of fibromyalgia
- Concurrent planned neutrophil colony stimulating factor therapy
- Prior exposure to paclitaxel within the last 6 months
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 |
|---|---|---|
| Omega-3 fatty acidAlso: Fish oil, n-3 fatty acid, O3FA, LovazaPatients receive omega-3 fatty acid capsules orally beginning 1 week prior to paclitaxel treatment. Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first). Each 1-gram capsule contains approximately 465 mg eicosapentaenoic acid (EPA) and 375 mg docosahexaenoic acid (DHA). | Dietary supplement | Arm I (Omega-3 fatty acid) |
| PlaceboPatients receive placebo capsules orally beginning 1 week prior to paclitaxel treatment. Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first) | Dietary supplement | Arm II (placebo) |
| PaclitaxelAlso: TaxolPatients will receive, as part of their standard of care, weekly paclitaxel at 70 to 90 mg/m2 intravenously for a minimum of 2 months. Treatment 3 out of 4 weeks is allowed. | Drug | Arm I (Omega-3 fatty acid), Arm II (placebo) |
Primary outcome
Mean severity of pain
Time frame: Up to 1 month after completion of therapy
Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.
1 secondary outcome
Incidence of pain or relief
Time frame: Up to 1 month after completion of therapy
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 5 Oct 2022.
- Derived from this study: PubMed 37847317Tawfik B, Dayao ZR, Brown-Glaberman UA, Pankratz VS, Lafky JM, Loprinzi CL, Barton DL. A pilot randomized, placebo-controlled, double-blind study of omega-3 fatty acids to prevent paclitaxel-associated acute pain syndrome in breast cancer patients: Alliance A22_Pilot2. Support Care Cancer. 2023 Oct 17;31(12):637. doi: 10.1007/s00520-023-08082-x.
- University of New Mexico Cancer CenterLink provided by the sponsor.
- New Mexico Cancer Care AllianceLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Zoneddy Dayao principal investigator
University of New Mexico Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid and Paclitaxel in people with Breast Cancer and Ovarian Neoplasm, run by New Mexico Cancer Research Alliance at 2 sites in United States.
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 10 inclusion and 5 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Mean severity of pain (time frame: Up to 1 month after completion of 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 NCT01821833, 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 5 Oct 2022.