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

What Was Tested

The trial (phase 3) is built around L-Carnitine for endometriosis.

It had two arms (groups): Arm I (acetyl-L-carnitine hydrochloride) (experimental) and Arm II (placebo) (placebo comparator).

Patients receive ALC PO BID on days 1-21 (during chemotherapy treatment).

Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).

The registry classes the interventions as dietary supplement and other.

More on the Plan

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 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).

Who Took Part

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent. The complete response to front-line chemotherapy must have included a negative physical exam, normalization of CA125 if elevated at baseline, and negative radiographic assessment of disease, if obtained. Stage not greater than IB. No more than superficial myometrial invasion, without vascular or lymphatic invasion. Patients must be expected to receive a minimum of 2 cycles of paclitaxel and a platinating agent for their recurrent disease;.

The full record lists 36 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

It started in 2012-04 with completion listed for 2015-05.

Its stated primary purpose is supportive care.

What Was Measured

It also tracked 3 secondary outcomes, for example Chemotherapy-related fatigue as measured with FACT-Fatigue, Patient-reported sensory peripheral neuropathy, as measured by the FACT/GOG-Ntx v4 subscale and Quality of life, as measured by the FACT-O TOI.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in people with endometriosis.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Endometriosis research.