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Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00516503
First received: August 14, 2007
Last updated: July 25, 2017
Last verified: July 2017
Results First Received: November 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Neurotoxicity
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: baclofen/amitriptyline/ketamine gel
Other: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two-hundred eight patients were enrolled to this study. Five patients cancelled prior to initiating protocol treatment and were therefore this study was analyzed using 203 remaining patients.

Reporting Groups
  Description
Baclofen-amitriptyline Hydrochloride-ketamine Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Placebo Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically

Participant Flow:   Overall Study
    Baclofen-amitriptyline Hydrochloride-ketamine   Placebo
STARTED   101   102 
COMPLETED   101   102 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Baclofen-amitriptyline Hydrochloride-ketamine Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Placebo Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Total Total of all reporting groups

Baseline Measures
   Baclofen-amitriptyline Hydrochloride-ketamine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   102   203 
Age 
[Units: Years]
Median (Full Range)
 59.5 
 (41 to 83) 
 62 
 (31 to 86) 
 61 
 (31 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      66  65.3%      60  58.8%      126  62.1% 
Male      35  34.7%      42  41.2%      77  37.9% 
Region of Enrollment 
[Units: Participants]
     
United States   101   102   203 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]   [ Time Frame: From baseline to 4 weeks ]

2.  Secondary:   Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4   [ Time Frame: From Baseline to week 4 ]

3.  Secondary:   Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4   [ Time Frame: Up to 4 weeks ]

4.  Secondary:   Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)   [ Time Frame: At 4 weeks ]

5.  Secondary:   Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4   [ Time Frame: Up to 4 weeks ]

6.  Secondary:   Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks   [ Time Frame: Up to 4 weeks ]

7.  Secondary:   Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0   [ Time Frame: Up to 4 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
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  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: Debra Barton, R.N., Ph.D.
Organization: Mayo Clinic
e-mail: Barton.debra@mayo.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00516503     History of Changes
Other Study ID Numbers: NCCTG-N06CA
NCI-2011-01768 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000560732 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: August 14, 2007
Results First Received: November 2, 2016
Last Updated: July 25, 2017