Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Paclitaxel is chemotherapeutic agent used in many of the most common anti-cancer regimens. Its use is frequently associated with moderate to severe muscle and joint pain that may persist for several days after the treatment. This side effect, known as "Arthralgia-Myalgia Syndrome, has a significant impact on the quality of life and functional abilities of those receiving the treatment, and is not alleviated by many of the interventions attempted for that purpose.

Sporadic reports suggest that a drug called gabapentin may be effective in the management of this adverse effect. Observations from our practice indicate that pregabalin, which possesses similar biological activity to that of gabapentin, may also be useful in preventing and treating paclitaxel associated myalgia - arthralgia.

The current study represents an initial evaluation of the hypothesis that pregabalin may be beneficial in the management of the symptoms due to the "Arthralgia-Myalgia Syndrome". The investigation will be carried out in the format of a small scale, randomized, placebo controlled trial with patients receiving paclitaxel in the course of standard treatment for breast cancer.

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

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Treatments: Paclitaxel; Pregabalin

Criteria

Screening Criteria:

• Signature of consent form.

• Legal competence for expression of consent.

• Patients with confirmed diagnosis of cancer of breast, free of confounding pain before the administration of chemotherapy.

• Recommendation for treatment with paclitaxel containing protocols, prior to initiation of chemotherapy.

• Age over 18.

Inclusion criteria for treatment phase:

• Fulfillment of screening criteria.

• Experience of myalgia-arthralgia related pain of moderate or worse degree of severity after a course of paclitaxel containing chemotherapy.

Exclusion Criteria:

• Ongoing treatment with pregabalin or gabapentin.

• Known restricting adverse events related to treatment with pregabalin or gabapentin.

• Renal failure with GFR less than 30ml/min.

• Participation in clinical trial 3 weeks or less prior to screening.

• Confounding myalgia and / or arthralgia unrelated to chemotherapy.

• Medical condition compromising the likelihood of completing the trial.