Otake, A., Yoshino, K., Ueda, Y., Sawada, K., Mabuchi, S., Kimura, T., . . . Kimura, T. (2015). Usefulness of duloxetine for Paclitaxel-induced peripheral neuropathy treatment in gynecological cancer patients. Anticancer Research, 35, 359–363.

To explore the potential efficacy of duloxetine for use against chemotherapy-induced peripheral neuropathy (CIPN) among patients with gynecologic cancers receiving paclitaxel

The medical records of patients being treated with duloxetine were evaluated retrospectively. The severity of symptoms before and after duloxetine administration was evaluated according to documented patient responses as either responders (symptoms dropped more than 1 grade) or non-responders (patients had a stable or worsening grade of neuropathy). A maintenance dose of duloxetine at 20 mg per day was given in 18 cases, and 40 mg per day was given in seven cases. In 12 cases, duloxetine administration began during chemotherapy. In 13 cases, it was started after chemotherapy (in four of these cases, one year after the completion of chemotherapy).

• N = 25  
• MEDIAN AGE = 62 years (range = 40–77 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Ovarian, corpus, and cervical cancers; all were receiving paclitaxel and carboplatin with or without epirubicin; median accumulated dose of paclitaxel was 1,805 mg per body; accumulated median dose of carboplatin was 3,368 mg
• OTHER KEY SAMPLE CHARACTERISTICS: Prior to duloxetine, medications used in some patients included goshajinkigan, pregaabalin, vitamin B12, and SSRIs.

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Japan

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

Retrospective, observational trial

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 4.0

56% of patients responded to duloxetine and 44% did not respond. An analysis of demographic, disease, and treatment-related variables showed no significant association between any of these factors and the effectiveness of duloxetine. Adverse events were mild, and duloxetine generally was well tolerated. Overall, older patients tended to be less responsive to duloxetine.

The majority of patients responded to duloxetine, suggesting that in some patients, it can be helpful in managing the symptoms of CIPN.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable

The findings of this study suggest that duloxetine may be helpful for some patients for the prevention and management of CIPN. However, it was not effective in all cases. The study's findings were limited by its design. Additional research studies exploring effective dosages, the types of CIPN that respond to duloxetine, appropriate timing, and effects of duloxetine on the full range of CIPN symptoms rather than just pain are needed.