Clinical Trial: Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Randomized, Double-Blinded, Placebo Controlled Phase III Trial Using Acetyl-L-Carnitine(ALC)(NSC# 747431) for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Patients With Recurrent
Brief Summary: This randomized phase III trial studies how well acetyl-L-carnitine hydrochloride works compared to a placebo in preventing peripheral neuropathy in patients with recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing chemotherapy. Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine hydrochloride is more effective compared to a placebo in preventing peripheral neuropathy caused by chemotherapy.
Detailed Summary:
PRIMARY OBJECTIVES:
I. 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 OBJECTIVES:
I. Evaluate the effect of ALC on chemotherapy-induced fatigue based upon the Functional Assessment of Cancer Therapy (FACT)-Fatigue scale.
II. 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).
III. 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
Sponsor: Gynecologic Oncology Group
Current Primary Outcome: Chemotherapy-related peripheral neuropathy as measured with Functional Assessment of Cancer Therapy (FACT)/GOG-Ntx subscale [ Time Frame: Up to 3 months ]
Original Primary Outcome: Effect of ALC compared to placebo in preventing the chemotherapy-related peripheral neuropathy as measured with FACT/GOG-Ntx subscale
Current Secondary Outcome:
- Chemotherapy-related fatigue as measured with FACT-Fatigue [ Time Frame: Up to 3 months ]
- Patient-reported sensory peripheral neuropathy, as measured by the FACT/GOG-Ntx v4 subscale [ Time Frame: Up to 3 months ]
- Quality of life, as measured by the FACT-O TOI [ Time Frame: Up to 3 months ]Tested at significance level of 5%.
Original Secondary Outcome:
- Effect of ALC compared to placebo in preventing the chemotherapy-related fatigue as measured with FACT-Fatigue
- Effect of ALC vs placebo on preventing the patient-reported sensory peripheral neuropathy, as measured by the FACT/GOG-Ntx_4 subscale
- Effect of ALC on the quality of life, as measured by the FACT-O TOI
Information By: Gynecologic Oncology Group
Dates:
Date Received: December 14, 2011
Date Started: April 2012
Date Completion:
Last Updated: December 29, 2014
Last Verified: December 2014