A Phase 2/3 interventional study of alpha-lipoic acid and Audiology in Ototoxicity and Unspecified Adult Solid Tumor, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-07.
Sponsored by US Department of Veterans Affairs · Phase 2/3, Interventional, and Supportive care
RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin.
PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin.
OBJECTIVES:
Primary
Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin.
Secondary
Determine if this drug improves the oxidative state, as measured by a malondialdehyde measurement of oxidative stress, thereby protecting the patient against ototoxic-induced hearing loss.
OUTLINE: This is a placebo-controlled, double-blind, randomized, multicenter study. Patients are stratified by cancer stage and institution. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral alpha-lipoic acid supplement once a day beginning 1 week before the start of cisplatin treatment and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.
Arm II: Patients receive oral placebo supplement once a day beginning 1 week before the start of cisplatin and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.
Hearing and ototoxicity are assessed at baseline, on each day of chemotherapy, and at 1 and 3 months post chemotherapy.
Blood samples are collected periodically to measure malondialdehyde and alpha-lipoic acid levels.
After completion of treatment with cisplatin, patients are followed for 3 months.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's enrollment of 39 is below the median of 47 across 33 interventional studies indexed under Ototoxicity.
Browse Ototoxicity studies →US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receiving alpha-lipoic acid during cisplatin treatment.
Drug: alpha-lipoic acid · Behavioral: Audiology · Biological: laboratory biomarker analysis
Receiving placebo during cisplatin treatment
Behavioral: Audiology · Biological: laboratory biomarker analysis · Drug: Placebo
Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Also known as: lipoic acid
otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
Also known as: ototoxicity monitoring
Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
Also known as: MDA
Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
Ototoxicity Measurement
Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement. ASHA criteria are defined as * 20 decibel (dB) increase at any test frequency, * 10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies.
Time frame: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.
Malondialdehyde (MDA) Levels
Computed maximum increase relative to baseline for each subject = (max MDA during treatment) - baseline MDA level.
Time frame: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.
Total Amount of Prescribed Cisplatin Dose Administered
Maximum cumulative dose of cisplatin (mg/m\^2) administered during the course of chemotherapy.
Time frame: cisplatin treatment period between 10 weeks and up to 16 weeks.
| Milestone | Alpha-lipoic Acid | Placebo |
|---|---|---|
| Started | 19 | 20 |
| Completed | 12 | 13 |
| Not completed | 7 | 7 |
| Withdrew: Lost to follow-up | 7 | 7 |
Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement. ASHA criteria are defined as * 20 decibel (dB) increase at any test frequency, * 10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies.
| participants | Arm 1 | Arm 2 |
|---|---|---|
| Ototoxicity Measurement | 7 | 7 |
Computed maximum increase relative to baseline for each subject = (max MDA during treatment) - baseline MDA level.
| uM=micro-moles/liter | Arm 1 | Arm 2 |
|---|---|---|
| Malondialdehyde (MDA) Levels | 0.27 ± 1.00 | 0.47 ± 0.83 |
Maximum cumulative dose of cisplatin (mg/m\^2) administered during the course of chemotherapy.
| mg/m^2 | Arm 1 | Arm 2 |
|---|---|---|
| Total Amount of Prescribed Cisplatin Dose Administered | 239.7 ± 92.6 | 191.5 ± 110.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 5/19 (26.3%) | 3/19 (15.8%) |
| Arm 2 | — | 6/20 (30%) | 2/20 (10%) |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| Acute Renal FailureRenal and urinary disorders | 0/19 | 3/20 |
| NeutropeniaBlood and lymphatic system disorders | 1/19 | 2/20 |
| Nausea/vomittingGastrointestinal disorders | 1/19 | 0/20 |
| Blood transfusionBlood and lymphatic system disorders | 1/19 | 1/20 |
| EsophagitisGastrointestinal disorders | 1/19 | 0/20 |
| sceptic shockInfections and infestations | 1/19 | 0/20 |
| PancreatitisEndocrine disorders | 0/19 | 1/20 |
| hypoxic respiratory failureRespiratory, thoracic and mediastinal disorders | 0/19 | 1/20 |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| Distended abdomenGastrointestinal disorders | 1/19 | 0/20 |
| Atrial FibrillationCardiac disorders | 1/19 | 0/20 |
| Muscle WeaknessMusculoskeletal and connective tissue disorders | 1/19 | 0/20 |
| Small bowel obstructionGastrointestinal disorders | 0/19 | 1/20 |
| Spine painMusculoskeletal and connective tissue disorders | 0/19 | 1/20 |
| Age, Categorical(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 15 | 27 |
| >=65 years | 7 | 5 | 12 |
| Age, Continuous(years) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 62.0 ± 10.2 | 60.6 ± 12.3 | 61.2 ± 11.2 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 19 | 19 | 38 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| United States | 19 | 20 | 39 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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