Trial record 8 of 305 for:    Open Studies | "Fatty Acids"

Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by New Mexico Cancer Care Alliance
Sponsor:
Collaborator:
Alliance Healthcare Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01821833
First received: March 27, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

This randomized pilot clinical trial studies omega-3 fatty acid in treating pain in patients with breast or ovarian cancer receiving paclitaxel. Omega-3 fatty acid may help lessen pain caused by paclitaxel in patients with breast or ovarian cancer.


Condition Intervention
Breast Cancer
Ovarian Neoplasm
Pain
Dietary Supplement: omega-3 fatty acid
Dietary Supplement: placebo
Other: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Mean severity of pain [ Time Frame: Up to 1 month after completion of therapy ] [ Designated as safety issue: No ]
    Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.


Secondary Outcome Measures:
  • Incidence of pain or relief [ Time Frame: Up to 1 month after completion of therapy ] [ Designated as safety issue: No ]
    Fisher's exact test will be used for the incidence variable with 95% confidence intervals.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid PO QD or BID for 12 weeks. Patients complete quality-of-life assessment form.
Dietary Supplement: omega-3 fatty acid
Given PO
Other Names:
  • fish oil
  • n-3 fatty acid
  • O3FA
Other: quality-of-life assessment
Ancillary studies
Other Name: Quality of life assessment
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD or BID for 12 weeks. Patients complete quality-of-life assessment form.
Dietary Supplement: placebo
Given PO
Other Name: PLCB
Other: quality-of-life assessment
Ancillary studies
Other Name: Quality of life assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether omega-3 fatty acids can prevent or ameliorate paclitaxel associated pain syndrome (P-APS) in cancer patients.

SECONDARY OBJECTIVES:

I. To determine whether omega-3 fatty acids can prevent development of peripheral neuropathy.

II. To assess tolerability of omega -3 fatty acids in this setting. III. To compare quality of life (QOL) with omega 3 fatty acids supplementation versus placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) or twice daily (BID) for 12 weeks.

ARM II: Patients receive placebo PO QD or BID for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821833

Contacts
Contact: Valerie Parks, RN 505-925-0390 vparks@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Zoneddy R. Dayao, MD    505-925-5490    zdayao@salud.unm.edu   
Principal Investigator: Zoneddy R. Dayao         
Presbyterian Medical Group Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Wendy Burman, RN    505-559-6113      
Sub-Investigator: Bernard Agbemadzo, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Alliance Healthcare Foundation
Investigators
Principal Investigator: Zoneddy Dayao University of New Mexico Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01821833     History of Changes
Other Study ID Numbers: INST 1211, NCI-2013-00443
Study First Received: March 27, 2013
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New Mexico Cancer Care Alliance:
omega-3
fatty acids
paclitaxel
acute pain syndrome
peripheral neuropathy
chemotherapy induced neuropathy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014