Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01492920
Status:
WITHDRAWN
Last Update Posted:
2014-12-31
First Post:
2011-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Gynecologic Oncology Group
Organization:
Study Overview
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 Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Status:
WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 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.
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 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: