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A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients

Phase 3
18 Years
Not Enrolling
Neurotoxicity, Pain, Breast Cancer

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Trial Information

A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients

This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive oral D-cycloserine twice daily.

- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues
for up to 4 weeks in the absence of unacceptable toxicity. Patients may continue to
receive medication off-study at the discretion of their regular oncologist or primary

Inclusion Criteria

Selection of Patients - Eligibility Criteria

- Patients will be at least 18 years of age.

- Patients will be experiencing moderate to severe peripheral neuropathic pain

- Patients may be on chronic adjuvant pain medications such as antidepressants but must
be on stable doses for at least one week prior to admission.

- Patients may be taking concurrent opioids but they must be willing to allow us to
monitor their opioid use while on the trial.

- Chronic peripheral neuropathic pain will be defined as pain of 3 or more months
duration which began in association with chemotherapy.

- Patient's will have bilateral peripheral neuropathic pain symptoms primarily
involving the feet

- Patients may have breast cancer at any stage and no disease specific evaluations will
be taken or measured.

- Able to read and speak English and provide informed consent.

- Patients may be receiving chemotherapy as long as the agents are not known to cause a
peripheral neuropathy.

- Will not concurrently use gabapentin or pregabalin or must be willing to wean
offtheir anti-convulsant medications prior to starting the trial.

- Patients may have diabetes mellitus (type 1 or 2) as long as there is no preexisting

Exclusion criteria:

- Patients will not have secondary cause of neuropathic pain including:
HIV/AIDS,traumatic injury, or a personal history of non chemotherapy-induced

- Patients will not have a history of major depression or severe anxiety. This will be
evaluated at the initial visit

- Women of childbearing age will agree to take measures to prevent pregnancy and will
not breast-feed while on the study medication. Women who are currently pregnant will
not be invited to participate in this study.

- Patients will not have a history of seizures.

- Patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Compare self reported pain intensity score between the control and placebo groups by brief pain inventory

Outcome Description:

Compare the self-reported pain intensity in cancer patients receiving chemotherapy or anticancer drugs treated with D-cycloserine vs placebo.

Outcome Time Frame:

twice weekly during treatment (12 weeks)

Safety Issue:


Principal Investigator

Judith Paice, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 05CC2



Start Date:

February 2006

Completion Date:

May 2008

Related Keywords:

  • Neurotoxicity
  • Pain
  • Breast Cancer
  • pain
  • neurotoxicity
  • breast cancer
  • Breast Neoplasms
  • Neuralgia
  • Neurotoxicity Syndromes



Northwestern University Chicago, Illinois  60611
University of Wisconsin School of Medicine Madison, Wisconsin