Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn
Summary
Brief summary (as posted)
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.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Malignant Ovarian Mixed Epithelial Tumor | — | UNRESOLVED | — |
| Neuropathy | — | UNRESOLVED | — |
| Neurotoxicity Syndrome | — | UNRESOLVED | — |
| Ovarian Brenner Tumor | Ovarian Brenner Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Cystadenocarcinoma | Ovarian Clear Cell Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Adenocarcinoma | Ovarian Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Mucinous Cystadenocarcinoma | Ovarian Mucinous Cystadenocarcinoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetyl-L-Carnitine Hydrochloride | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (acetyl-L-carnitine hydrochloride)
- description
- Patients receive ALC PO BID on days 1-21 (during chemotherapy treatment).
- interventionNames
- Dietary Supplement: Acetyl-L-Carnitine Hydrochloride
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).
- interventionNames
- Other: Placebo
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
* Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner tumor, or adenocarcinoma not otherwise specified (N.O.S.)
* All patients must have had a treatment-free interval without clinical evidence of progressive disease of at least 6 months from completion of front-line chemotherapy (both platinum and taxane); front-line therapy may have included a biologic agent (i.e., bevacizumab)
* Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy
* Patients receiving hormonal therapy for biochemical or non-measurable recurrence disease are ELIGIBLE provided their recurrence is documented more than 6 months following the completion of primary cytotoxic chemotherapy; a minimum of 4 weeks must have expired since their last exposure to hormonal therapy
* 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
* Patients who have undergone reassessment laparotomy or laparoscopy following primary therapy are eligible for this study as long as they demonstrated a pathologic complete response based on the surgical assessment (i.e. all obtained specimens were histologically negative for disease)
* Patients with a past history of primary endometrial cancer within the last five years are excluded unless all of the following conditions are met:
* Stage not greater than IB
* No more than superficial myometrial invasion, without vascular or lymphatic invasion
* No poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
* Patients must be expected to receive a minimum of 2 cycles of paclitaxel and a platinating agent for their recurrent disease;
* Addition of other drugs such as bevacizumab is acceptable as long as these additional drugs are not typically associated with peripheral neuropathy
* The initial, planned infusion duration of each dose of paclitaxel must be 3 hours or less
* Patients must start the study with a GOG performance status of 2 or less
* Serum creatinine ≤ 2.5 mg/dL
* Neuropathy (sensory and motor) less than or equal to the National Cancer Institute (NCI) CTCAE v4.0 grade 1
* No patients with a history of seizure activity
* No patients who are unable to swallow oral medications
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years
* No patients of childbearing potential not practicing adequate contraception
* No patients who are pregnant or nursing
* No patients who are known to have diabetes
* No patients with known allergies to ALC (acetyl-L-carnitine hydrochloride)
* Patients are excluded if their previous cancer treatment contraindicates this protocol therapy
* No patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
* No patients receiving concurrent immunotherapy or radiotherapy
* No patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
* No patients who are currently receiving or have received warfarin or acenocoumarol within the past 7 days
* No patients taking \> 100 units of racemic vitamin E (or \> 50 units of ααα-tocopherol) daily within 5 days of starting study therapy
* No patients taking other medications (Rx, OTC, or dietary supplements) to prevent or treat neuropathy within 5 days of starting study treatment; such products include:
* Gabapentin (Neurontin ®)
* Pregabalin (Lyrica ®)
* Duloxetine (Cymbalta ®)
* Alpha-lipoic acid
* Note that tricyclic antidepressants or selective serotonin/norepinephrine-selective reuptake inhibitors prescribed for the treatment of mood disorders are allowedReferences
Publications (0)
Data not yet available