Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Pain Clinical Trial

Official title:

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602420
• Other study ID #: CDR0000584341
• Secondary ID: U10CA037420URCC-
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2008
• Last updated: October 13, 2015
• Start date: June 2008
• Est. completion date: March 2012

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

Description:

OBJECTIVES:

Primary

• To compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients with non-hematologic malignancies undergoing chemotherapy.

Secondary

• To identify potential risk factors for the development of PIBP.

• To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP.

• To assess the toxicity of naproxen when administered in the preventive setting.

OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.

• Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

• Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Diagnosis of a non-hematologic (non-myeloid) malignancy

• Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent

• Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia

• Creatinine = 1.5 times upper limit of normal

• Able to understand English

• More than 6 months since prior surgery on the heart

Exclusion Criteria:

• Pregnant or nursing

• Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers

• Allergy to naproxen

• Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs

• Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis

• Concurrent steroids on a regular basis

• Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (= 325 mg/day) of aspirin allowed

• Concurrent therapeutic doses of warfarin

Study Design

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

Related Conditions & MeSH terms

• Musculoskeletal Complications
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• naproxen
Oral naproxen twice daily for 5-8 days.

Other:
• placebo
Oral placebo twice daily for 5-8 days.

Locations

Country	Name	City	State
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	CCOP - Greenville	Greenville	South Carolina
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Metro-Minnesota	St. Louis Park	Minnesota
United States	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.	Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days.	From baseline through day 5	No