Prevention of Musculoskeletal Pain With Etoricoxib for Breast Cancer Patients Receiving Docetaxel Chemotherapy and Pegfilgrastim

• Status: Completed
• Trial end date: 2021-06-28
• Target enrollment: 0
• Participant gender: Female

Summary

Breast cancer patients who received docetaxel chemotherapy and prophylactic use of pegfilgrastim were randomly divided into two groups; experimental group: prophylactic etoricoxib (60 mg) was administered orally at each course of docetaxel-containing chemotherapy, which started from the day of chemotherapy and was performed once per day for 8 days (day 1-8); control group: no prophylactic regimen was given. Primary endpoint: overall incidence of musculoskeletal pain across all cycles of chemotherapy. Secondary endpoints: incidence, severity and duration of musculoskeletal pain at each cycle; incidence of severe musculoskeletal pain (score, defined as greater than 5 on a scale from 0 to 10) by cycle and across all cycles; Functional Assessment of Cancer Therapy-Breast (FACT-B) subscale at each cycle; incidence of peripheral neuropathy after all cycles of chemotherapy; adverse events.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital
• Treatments: Etoricoxib

Criteria

Inclusion Criteria:

• Signed informed consent

• Age ≥18 years

• Stage I-III breast cancer

• ECOG 0-2

• Received chemotherapy with docetaxel

• Prophylactic use of long-acting pegfilgrastim 24-48 hours after chemotherapy

Exclusion Criteria:

• Existed any chronic pain or peripheral neuropathy

• Prior history of gastrointestinal bleeding or ulcer

• Long-term history of receiving oral corticoids, nonsteroid anti-inflammatory drugs (NSAIDs) or anti-histamines

• Allergies to NSAIDs or aspirin

• Blood creatinine level exceeds 1.5 times of the upper limit of normal range