Clinical trial NCT04565600: Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib
Official title: Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib for Breast Cancer Patients: A Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain Syndrome
Keywords: Breast Cancer
Docetaxel
Etoricoxib
Acute pain syndrome
Peripheral neuropathy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall incidence of taxane-associated acute pain syndrome across all cycles of chemotherapy
timeFrame: 6 months
Secondary outcomes:
measure: incidence of taxane-associated acute pain syndrome at each cycle
timeFrame: 6 months
measure: severity of taxane-associated acute pain syndrome at each cycle
timeFrame: 6 months
measure: duration of taxane-associated acute pain syndrome at each cycle
timeFrame: 6 months
measure: incidence of severe taxane-associated acute pain syndrome by cycle and across all cycles
timeFrame: 6 months
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B) subscale at each cycle
timeFrame: 6 months
measure: incidence of peripheral neuropathy after all cycles of chemotherapy
timeFrame: 6 months
measure: adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Kun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Gao HF, Yang C, Zhu T, Ji F, Yang M, Zhang L, Li J, Cheng M, Zhang T, Shen B, Chen Y, Wang K. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022 Aug;171:150-160. doi: 10.1016/j.ejca.2022.05.019. Epub 2022 Jun 17.