Clinical trial NCT03407430 (phase 2, status: terminated)
Conditions: breast cancer, lymphoma, pain
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: pregabalin, placebo
SMILES: NCC1(CC(O)=O)CCCCC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    low patient accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Diagnosis of a non-myeloid hematologic malignancy scheduled to initiate a cycle of
             chemotherapy that requires prophylactic use of a granulocyte colony-stimulating growth
             factor (based on the provider's discretion), provided the schedule of chemotherapy
             cycles allows the use of pegfilgrastim at a dose of 6 mg SC once per cycle OR
             Diagnosis of breast cancer scheduled to initiate dose-dense doxorubicin and
             cyclophosphamide (AC) chemotherapy or docetaxel and cyclophosphamide (TC) chemotherapy
             that requires prophylactic use of a granulocyte colony-stimulating growth factor,
             provided the schedule of chemotherapy cycles allows the use of pegfilgrastim, at a
             dose of 6 mg SC once per cycle; pegfilgrastim scheduled for 24 hours post
             chemotherapy.

          -  Schedule of chemotherapy and pegfilgrastim initiation can accommodate initiation of
             pregabalin 4 days prior to pegfilgrastim dose.

          -  Baseline pain scores <7 as measured via 10-point numerical scale for pain (see section
             11.1); pain score and use of any non-opioid pain medication must be self-reported as
             stable (same dose and frequency) over the 7 days prior to screening; for opioids,
             patient must self-report the same dose and frequency over the 28 days prior to
             screening. Patients who are receiving peri-procedural short-acting analgesics will
             still be included as long as they are no longer receiving analgesics by D1 of
             chemotherapy.

        Exclusion Criteria:

          -  A history of (within one month) or current pregabalin use.

          -  Baseline pain scores ≥7 as measured via 10-point numerical scale for pain (see section
             11.1).

          -  Unwilling to discontinue use of antihistamines from 7 days prior to D1 of study
             medication.

          -  Creatinine clearance (CrCl) ≤60 ml/min (as measured via Cockcroft-Gault) based on
             serum creatinine measured as part of standard of care prior to administration of
             chemotherapy

          -  Women of childbearing potential must have a negative serum pregnancy test prior to
             initiating therapy (note, this test should be standard of care prior to administration
             of chemotherapy).

          -  Patient is unable or unwilling to abide by the study protocol or cooperate fully with
             the investigator.

          -  Eligible and agrees to enroll into therapeutic trial ongoing at the Lineberger
             Comprehensive Cancer Center (LCCC) (i.e., the treatment trial will take precedence
             over LCCC1314).

          -  Currently receiving therapeutic doses of anticoagulants (ie, prophylactic use of
             anticoagulants is allowed) due to possibility of dizziness and falls while on
             pregabalin.

          -  Currently receiving aromatase inhibitors or agents targeted against Ph+ leukemias
             (i.e., imatinib, dasatinib, nilotinib, and ponatinib) or scheduled to start these
             drugs during cycle 1 of scheduled chemotherapy.

          -  Presence of bone metastases.

          -  History of angioedema.

          -  History of a seizure disorder.