Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02024568
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02024568
Study Brief:
Protocol Section:
NCT02024568