Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00477607
First received: May 23, 2007
Last updated: February 3, 2014
Last verified: February 2014
Results First Received: October 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Ototoxicity
Unspecified Adult Solid Tumor
Interventions: Drug: alpha-lipoic acid
Behavioral: Audiology
Biological: laboratory biomarker analysis
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alpha-lipoic Acid

Receiving alpha-lipoic acid during cisplatin treatment.

alpha-lipoic acid : Supplements (1200mg once a day) was administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment.

Placebo

Receiving placebo during cisplatin treatment

Placebo supplements (1200mg once a day) were administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment.


Participant Flow:   Overall Study
    Alpha-lipoic Acid     Placebo  
STARTED     19     20  
COMPLETED     12     13  
NOT COMPLETED     7     7  
Lost to Follow-up                 7                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1

Receiving alpha-lipoic acid during cisplatin treatment.

laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

alpha-lipoic acid : 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.

Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

Arm 2

Receiving placebo during cisplatin treatment

Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.

alpha-lipoic acid : 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.

laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  19     20     39  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     15     27  
>=65 years     7     5     12  
Age  
[units: years]
Mean ± Standard Deviation
  62.0  ± 10.2     60.6  ± 12.3     61.2  ± 11.2  
Gender  
[units: participants]
     
Female     0     1     1  
Male     19     19     38  
Region of Enrollment  
[units: participants]
     
United States     19     20     39  



  Outcome Measures
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1.  Primary:   Ototoxicity Measurement   [ Time Frame: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment. ]

2.  Secondary:   Malondialdehyde (MDA) Levels   [ Time Frame: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment. ]

3.  Secondary:   Total Amount of Prescribed Cisplatin Dose Administered   [ Time Frame: cisplatin treatment period between 10 weeks and up to 16 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Missing data constraints have the number of subjects in the study being different for different outcomes.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dawn Konrad-Martin
Organization: VA RR&D National Center for Rehbilitative Auditory Research
phone: 503-220-8262 ext 52962
e-mail: dawn.martin@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00477607     History of Changes
Obsolete Identifiers: NCT00570596
Other Study ID Numbers: C4697-R, CDR0000546570, NCRAR-VA-1810, OHSU-3288
Study First Received: May 23, 2007
Results First Received: October 4, 2013
Last Updated: February 3, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration