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

NCT01821833 | Completed DMC

• 2 other identifiers: INST 1211NCI-2013-00443
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Breast Cancer; Ovarian Neoplasm; Pain

Keywords

omega-3; fatty acids; paclitaxel; acute pain syndrome; peripheral neuropathy; chemotherapy induced neuropathy

Outcome Measures

Primary Outcomes (1)

• Mean severity of pain

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

  Up to 1 month after completion of therapy

Secondary Outcomes (1)

• Incidence of pain or relief

  Up to 1 month after completion of therapy

Study Arms (2)

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.

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.

Dietary Supplement: Placebo; Drug: Paclitaxel

Interventions

Omega-3 fatty acid DIETARY_SUPPLEMENT

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).

Also known as: Fish oil, n-3 fatty acid, O3FA, Lovaza

Arm I (Omega-3 fatty acid)

Placebo DIETARY_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)

Arm II (placebo)

Paclitaxel DRUG

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.

Also known as: Taxol

Arm I (Omega-3 fatty acid); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• Alliance Healthcare Foundation: collaborator

Study Sites (2)

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Presbyterian Medical Group

Albuquerque, New Mexico, 87110, United States

Location

Related Publications (1)

• 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.

  PMID: 37847317 DERIVED

Related Links

• University of New Mexico Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Pain; Peripheral Nervous System Diseases

Interventions

Fatty Acids, Omega-3; Fish Oils; Omacor; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Zoneddy Dayao

  University of New Mexico Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: May 24, 2016
• Primary Completion: January 16, 2018
• Study Completion: August 3, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)