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Trial record 14 of 135 for:    AMITRIPTYLINE

Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00471445
Recruitment Status : Completed
First Posted : May 10, 2007
Results First Posted : June 10, 2015
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Neurotoxicity
Pain
Peripheral Neuropathy
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: ketamine/amitriptyline NP-H cream
Other: placebo
Enrollment 462
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr Placebo Cream
Hide Arm/Group Description

Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

ketamine/amitriptyline NP-H cream: Applied topically

Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

placebo: Applied topically

Period Title: Overall Study
Started 229 233
Completed 227 231
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             1
Ineligible             1             0
Protocol Violation             0             1
Arm/Group Title Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr Placebo Cream Total
Hide Arm/Group Description

Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

ketamine/amitriptyline NP-H cream: Applied topically

Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

placebo: Applied topically

Total of all reporting groups
Overall Number of Baseline Participants 227 231 458
Hide Baseline Analysis Population Description
The number of 458 does not include 2 subjects from the Placebo cream and 2 subjects from the Amitriptyline and ketamine hydrochloride topical analgesic cream group who did not provide baseline data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 227 participants 231 participants 458 participants
60.7  (10.5) 60.6  (10.0) 60.7  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
Female
156
  68.7%
171
  74.0%
327
  71.4%
Male
71
  31.3%
60
  26.0%
131
  28.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
Hispanic or Latino
6
   2.6%
6
   2.6%
12
   2.6%
Not Hispanic or Latino
220
  96.9%
224
  97.0%
444
  96.9%
Unknown or Not Reported
1
   0.4%
1
   0.4%
2
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
   8.8%
18
   7.8%
38
   8.3%
White
199
  87.7%
206
  89.2%
405
  88.4%
More than one race
8
   3.5%
7
   3.0%
15
   3.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 227 participants 231 participants 458 participants
227 231 458
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
Completed graduate training 28 19 47
Standard college or university (4 years) 53 55 108
Partial college training (<4 years) 76 80 156
High school graduate 63 65 128
Not high school educated 7 12 19
Marital status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
Married 165 160 325
Divorced 20 25 45
Separated 2 3 5
Single 23 21 44
Widowed 17 22 39
Previous treatment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
Previous surgery 198 195 393
Previous chemotherapy 227 231 458
Previous radiation therapy 114 109 223
[1]
Measure Description: Sum of participants in each treatment category will not sum to the overall number of baseline participants since participants may belong in multiple categories.
Site   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
Hematologic 24 18 42
Head and neck 7 5 12
Lung 12 23 35
GI 55 69 124
Genitourinary tract 15 9 24
Gynecologic 15 16 31
Breast 96 88 184
Skin 1 1 2
Melanoma 0 1 1
Soft tissue sarcoma 2 1 3
Bone and cartilaginous 2 0 2
Cardiac 0 1 1
Other 5 4 9
[1]
Measure Description: Sum of participants in each site category will not sum to the overall number of baseline participants since participants may belong in multiple categories.
Regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 227 participants 231 participants 458 participants
Taxanes 126 120 246
Non-Taxane 101 111 212
1.Primary Outcome
Title Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo
Hide Description Cancer survivors who completed chemotherapy at least 1 month prior and had Chemotherapy Induced Peripheral Neuropathy (CIPN) (greater than or equal to 4 out of 10) were enrolled. CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average "pain, numbness, or tingling in their hands and feet over the past 24 hours" on an 11-point numeric rating scale at baseline and 6 weeks post intervention. CIPN ranges from 0 (no pain) to 10 (worst possible pain).
Time Frame Week 6 - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine/Amitriptyline NP-H Cream Placebo Cream
Hide Arm/Group Description:

Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

ketamine/amitriptyline NP-H cream: Applied topically

Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

placebo: Applied topically

Overall Number of Participants Analyzed 227 231
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Baseline
6.55
(6.35 to 6.76)
6.47
(6.28 to 6.66)
Week 6
4.93
(4.59 to 5.27)
5.19
(4.89 to 5.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine/Amitriptyline NP-H Cream, Placebo Cream
Comments Tested at the two-sided 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.363
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.174
Confidence Interval (2-Sided) 95%
-0.548 to 0.201
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.190
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr Placebo Cream
Hide Arm/Group Description

Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

ketamine/amitriptyline NP-H cream: Applied topically

Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

placebo: Applied topically

All-Cause Mortality
Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   4/227 (1.76%)   4/231 (1.73%) 
Cardiac disorders     
Arrythmia recurrence - pacemaker placed  0/227 (0.00%)  1/231 (0.43%) 
Open Heart Surgery  1/227 (0.44%)  0/231 (0.00%) 
Gastrointestinal disorders     
Dysphagia  0/227 (0.00%)  1/231 (0.43%) 
Immune system disorders     
Allergic Rhinitis  0/227 (0.00%)  1/231 (0.43%) 
Musculoskeletal and connective tissue disorders     
Pain in ribs  1/227 (0.44%)  0/231 (0.00%) 
Nervous system disorders     
Sensory Neuropathy  1/227 (0.44%)  0/231 (0.00%) 
Renal and urinary disorders     
Vaginal Bleeding  0/227 (0.00%)  1/231 (0.43%) 
Skin and subcutaneous tissue disorders     
Skin Rash  1/227 (0.44%)  0/231 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   147/227 (64.76%)   158/231 (68.40%) 
Blood and lymphatic system disorders     
Thrombocytopenia  0/227 (0.00%)  1/231 (0.43%) 
Anemia  3/227 (1.32%)  1/231 (0.43%) 
Lymphopenia  1/227 (0.44%)  0/231 (0.00%) 
Cardiac disorders     
Hypertension  5/227 (2.20%)  5/231 (2.16%) 
Cardiac Arrythmia  1/227 (0.44%)  1/231 (0.43%) 
Increased Heart Rate  2/227 (0.88%)  1/231 (0.43%) 
Congestive Heart Failure  1/227 (0.44%)  0/231 (0.00%) 
Ear and labyrinth disorders     
Dizziness  2/227 (0.88%)  3/231 (1.30%) 
Tinnitus  2/227 (0.88%)  1/231 (0.43%) 
Endocrine disorders     
Diabetes  0/227 (0.00%)  2/231 (0.87%) 
Hypothyroidism  2/227 (0.88%)  1/231 (0.43%) 
Hyperglycemia  6/227 (2.64%)  2/231 (0.87%) 
Hypercholestremia  0/227 (0.00%)  1/231 (0.43%) 
Hyperlipidemia  1/227 (0.44%)  0/231 (0.00%) 
Gastrointestinal disorders     
Nausea  2/227 (0.88%)  7/231 (3.03%) 
Vomiting  2/227 (0.88%)  4/231 (1.73%) 
Abdominal Pain  3/227 (1.32%)  0/231 (0.00%) 
Diarrhea  2/227 (0.88%)  6/231 (2.60%) 
Dysphagia  1/227 (0.44%)  1/231 (0.43%) 
Dyspepsia  3/227 (1.32%)  4/231 (1.73%) 
Constipation  1/227 (0.44%)  4/231 (1.73%) 
GI Fistula  1/227 (0.44%)  0/231 (0.00%) 
GERD  2/227 (0.88%)  0/231 (0.00%) 
Mucositis  1/227 (0.44%)  1/231 (0.43%) 
Black Tarry Stool  0/227 (0.00%)  1/231 (0.43%) 
General disorders     
Fatigue  8/227 (3.52%)  11/231 (4.76%) 
Hotflashes  1/227 (0.44%)  0/231 (0.00%) 
Insomnia  5/227 (2.20%)  7/231 (3.03%) 
Headache  4/227 (1.76%)  3/231 (1.30%) 
Hepatobiliary disorders     
Liver enzymes  2/227 (0.88%)  4/231 (1.73%) 
Immune system disorders     
Allergic Rhinitis  5/227 (2.20%)  2/231 (0.87%) 
Red and Crusty Eye  1/227 (0.44%)  0/231 (0.00%) 
Nasal Congestion  1/227 (0.44%)  3/231 (1.30%) 
Infections and infestations     
Fever  3/227 (1.32%)  4/231 (1.73%) 
Infection - Herpes Zoster  2/227 (0.88%)  1/231 (0.43%) 
Head Cold  1/227 (0.44%)  2/231 (0.87%) 
Otitis Media  1/227 (0.44%)  0/231 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  3/227 (1.32%)  1/231 (0.43%) 
Chills  0/227 (0.00%)  2/231 (0.87%) 
Dehydration  2/227 (0.88%)  1/231 (0.43%) 
Drymouth  1/227 (0.44%)  0/231 (0.00%) 
Hypocalcemia  1/227 (0.44%)  1/231 (0.43%) 
Hypokalemia  1/227 (0.44%)  1/231 (0.43%) 
Hypoalbumin  1/227 (0.44%)  1/231 (0.43%) 
Hypotension  1/227 (0.44%)  0/231 (0.00%) 
Hypomagnesium  0/227 (0.00%)  1/231 (0.43%) 
Musculoskeletal and connective tissue disorders     
Pain Lower Extremities  5/227 (2.20%)  14/231 (6.06%) 
Myalgia  6/227 (2.64%)  11/231 (4.76%) 
Pain in Joint  5/227 (2.20%)  4/231 (1.73%) 
Pain Upper Extremities  2/227 (0.88%)  4/231 (1.73%) 
Pain in Bone  3/227 (1.32%)  0/231 (0.00%) 
Pain in Knee  4/227 (1.76%)  2/231 (0.87%) 
Pain in Head / Neck  4/227 (1.76%)  3/231 (1.30%) 
Pain in Back  2/227 (0.88%)  0/231 (0.00%) 
Nervous system disorders     
Migraine  3/227 (1.32%)  1/231 (0.43%) 
Neuropathy  6/227 (2.64%)  8/231 (3.46%) 
Ataxia  1/227 (0.44%)  0/231 (0.00%) 
Cramps  2/227 (0.88%)  2/231 (0.87%) 
Restless Leg Syndrome  4/227 (1.76%)  0/231 (0.00%) 
Psychiatric disorders     
Anxiety  1/227 (0.44%)  6/231 (2.60%) 
Depression  1/227 (0.44%)  2/231 (0.87%) 
Reproductive system and breast disorders     
Urinary Tract Infection  2/227 (0.88%)  3/231 (1.30%) 
Benign Prostate Hyperplasia  0/227 (0.00%)  1/231 (0.43%) 
Bladder Spasms, Occasional  1/227 (0.44%)  0/231 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  4/227 (1.76%)  7/231 (3.03%) 
Bronchitis  3/227 (1.32%)  4/231 (1.73%) 
Dyspnea  2/227 (0.88%)  5/231 (2.16%) 
Pneumonia  1/227 (0.44%)  3/231 (1.30%) 
Skin and subcutaneous tissue disorders     
Edema - Upper Extremities  2/227 (0.88%)  1/231 (0.43%) 
Edema - Lower Extremities  1/227 (0.44%)  4/231 (1.73%) 
Burning Sensation  4/227 (1.76%)  3/231 (1.30%) 
Rash - NOS  2/227 (0.88%)  7/231 (3.03%) 
Rash - Lower Extremities  5/227 (2.20%)  1/231 (0.43%) 
Dry Skin  4/227 (1.76%)  1/231 (0.43%) 
Skin Ulcerations  1/227 (0.44%)  1/231 (0.43%) 
Rosacea  2/227 (0.88%)  1/231 (0.43%) 
Feeling of Tightness / Flusing in Feet  2/227 (0.88%)  0/231 (0.00%) 
Since ketamine and amitriptyline are both analgesics, it is possible that the effects of the ketamine plus amitriptyline-containing creams may have been diluted when all three neuropathy symptoms were assessed together.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles E. Heckler, PhD, MS. Research Assistant Professor
Organization: University of Rochester Medical Center
Phone: 585-273-1141
EMail: checkler@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT00471445     History of Changes
Other Study ID Numbers: CDR0000543103
U10CA037420 ( U.S. NIH Grant/Contract )
URCC-0605 ( Other Identifier: NCI/DCP )
URCC07004 ( Other Identifier: University of Rochester )
First Submitted: May 8, 2007
First Posted: May 10, 2007
Results First Submitted: August 20, 2014
Results First Posted: June 10, 2015
Last Update Posted: November 9, 2015