A Randomized, Double-Blind, Placebo Controlled Phase III Trial Using ACETYL-L-Carnitine (ALC) (NSC# 747431) for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
OBJECTIVES:
Primary
- Evaluate the therapeutic efficacy of acetyl-L-carnitine hydrochloride (ALC) in
preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with recurrent
ovarian, primary peritoneal, or fallopian tube cancer.
Secondary
- Evaluate the effect of ALC on chemotherapy-induced fatigue based upon the Functional
Assessment of Cancer Therapy (FACT)-Fatigue scale.
- Evaluate the effect of ALC on sensory peripheral neuropathy as measured with the first
4 items of the FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity (Ntx) subscale
(FACT/GOG-Ntx_4 subscale).
- Evaluate the effect of ALC on the health-related quality of life as measured by the
FACT-Ovarian (O) trial outcome index (TOI).
OUTLINE: This is a multicenter study. Patients are stratified according to planned dosage of
paclitaxel (< 150 mg/m^2 vs ≥ 150 mg/m^2), and age (< 60 years of age vs ≥ 6 years of age).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive acetyl-L-carnitine hydrochloride (ALC) orally (PO) twice daily
(BID) on days 1-21 (during chemotherapy treatment).
- Arm II: Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment)
(maximum of 8 courses).
In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity.
Patients also complete questionnaires comprising the Functional Assessment of Cancer Therapy
(FACT)-Fatigue scale, the FACT-Gynecologic Oncology Group Neurotoxicity subscale
(FACT/GOG-Ntx_4 subscale), and the FACT-Ovarian trial outcome index (FACT-O TOI) at
baseline, prior to courses 3 and 5, within 4 weeks after completion of treatment, and then
at 3 months after completion of treatment.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Effect of ALC compared to placebo in preventing the chemotherapy-related peripheral neuropathy as measured with FACT/GOG-Ntx subscale
No
David M. Kushner, MD
Study Chair
University of Wisconsin, Madison
Unspecified
CDR0000719317
NCT01492920
February 2012
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