Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib

Pain Syndrome Clinical Trial

Official title:

Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib for Breast Cancer Patients: A Phase II Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565600
• Other study ID #: 20190516
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: January 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase II randomized clinical trial was conducted to determine whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Description:

Docetaxel plays a key role in reducing the recurrence of early-stage breast cancer as well as improving survival outcomes of advanced breast cancer patients, but it causes a variety of adverse events, including myalgia and arthralgia, peripheral neuropathy, febrile neutropenia, and hypersensitivity reactions and so on. The myalgia and arthralgia induced by docetaxel, which have been together referred to as taxane-associated acute pain syndrome (T-APS), were reported to occur in 3.6% to 70% of patients, and the symptoms usually occurred 24-48 hours after docetaxel infusion and lasted for 3-5 days. Previous studies found that patients who experienced myalgia and arthralgia due to docetaxel administration were more likely to have chronic peripheral neuropathy, which supported that T-APS could be a form of neurologic toxicity. T-APS may significantly influence patients' sleep and daily life, and even caused discontinuation of chemotherapy. Therefore, it is clinically meaningful to explore some prophylactic drugs for the T-APS. Previous studies had used glutamine, corticosteroids, Shakuyaku-Kanzo-To (a Japanese herb), and gabapentin to prevent paclitaxel-induced myalgia and arthralgia, but failed to provide enough evidence for clinical practice. Etoricoxib, a selective COX-2 inhibitor, is a nonsteroidal anti-inflammatory drug (NSAID) that has showed comparable efficacy in acute and chronic pain, with fewer gastrointestinal (GI) adverse events compared with traditional NSAIDs. Therefore, we conducted a phase II randomized clinical trial to investigate whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 28, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age =18 years

• Stage I-III breast cancer

• ECOG 0-2

• Received docetaxel-containing 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

Related Conditions & MeSH terms

• Acute Pain
• Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Etoricoxib
Etoricoxib 60 Mg Oral Tablet

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall incidence of taxane-associated acute pain syndrome across all cycles of chemotherapy	Total incidence of myalgia and arthralgia of patients across all cycles of docetaxel chemotherapy	6 months
Secondary	incidence of taxane-associated acute pain syndrome at each cycle	Incidence of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy	6 months
Secondary	severity of taxane-associated acute pain syndrome at each cycle	Severity of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy; the severity of pain was evaluated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).	6 months
Secondary	duration of taxane-associated acute pain syndrome at each cycle	Duration of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy; the duration of pain was counted by days.	6 months
Secondary	incidence of severe taxane-associated acute pain syndrome by cycle and across all cycles	incidence of severe myalgia and arthralgia (score, defined as greater than 5 on a scale from 0 to 10) of patients during the period of docetaxel chemotherapy by cycle and across all cycles	6 months
Secondary	Functional Assessment of Cancer Therapy-Breast (FACT-B) subscale at each cycle	Functional Assessment of Cancer Therapy-Breast(FACT-B)subscale during the period of docetaxel chemotherapy was assessed; the scores range from 0 to 144, higher scores mean a better outcome (higher quality of life)	6 months
Secondary	incidence of peripheral neuropathy after all cycles of chemotherapy	Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale (FACT-Ntx score <44), Eastern Cooperative Oncology Group neuropathy scale (ENS) subscale and EMG were performed at 3 months after the completion of chemotherapy.	6 months
Secondary	adverse events	Assessment of adverse events was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale.	6 months