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A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Ovarian Neoplasm, Pain

Thank you

Trial Information

A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Mean severity of pain

Outcome Description:

Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.

Outcome Time Frame:

Up to 1 month after completion of therapy

Safety Issue:

No

Principal Investigator

Zoneddy Dayao

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

INST 1211

NCT ID:

NCT01821833

Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Ovarian Neoplasm
  • Pain
  • omega-3
  • fatty acids
  • paclitaxel
  • acute pain syndrome
  • peripheral neuropathy
  • chemotherapy induced neuropathy
  • Breast Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Presbyterian Medical Group Albuquerque, New Mexico  87110