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Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Head and Neck Carcinoma

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ClinicalTrials.gov Identifier: NCT01386632
Recruitment Status : Active, not recruiting
First Posted : July 1, 2011
Results First Posted : June 14, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sanford Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Squamous Cell Carcinoma of the Head and Neck
Interventions Drug: DCA (dichloroacetate)
Drug: Placebo
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DCA (Dichloroacetate) Treatment Placebo
Hide Arm/Group Description

DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
Period Title: Overall Study
Started 25 25
Completed 20 21
Not Completed 5 4
Arm/Group Title DCA (Dichloroacetate) Treatment Placebo Total
Hide Arm/Group Description

DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin. Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
60.89  (9.06) 58.35  (8.33) 59.62  (8.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
1
   4.0%
6
  24.0%
7
  14.0%
Male
24
  96.0%
19
  76.0%
43
  86.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
0
   0.0%
1
   4.0%
1
   2.0%
Not Hispanic or Latino
24
  96.0%
24
  96.0%
48
  96.0%
Unknown or Not Reported
1
   4.0%
0
   0.0%
1
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
25
 100.0%
24
  96.0%
49
  98.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
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 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Percentage of Participants Who Experienced Adverse Events During Treatment.
Hide Description Percentage of Participants Who Experienced Adverse Events During Treatment including but are not limited to mucositis, leucopenia, neuropathy, and treatment breaks. This will be done according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Time Frame Adverse events (AE) will be assessed from the time the subject begins the study until the 30-days after receiving the last dose of the study medication.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DCA (Dichloroacetate) Treatment Placebo
Hide Arm/Group Description:

DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
96
(79.7 to 99.9)
96
(79.7 to 99.9)
2.Secondary Outcome
Title Two-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description

Outcome of tumor change will be compared in two separate ways. First, change in measured tumor size at 8 weeks and 3 months will be compared using standard linear models methods (using appropriate transformation to reduce statistical skew).

Progression was determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions.

Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DCA (Dichloroacetate) Treatment Placebo
Hide Arm/Group Description:

DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
86.5
(72.3 to 100)
87.5
(74.3 to 100)
3.Secondary Outcome
Title Two-year and Five-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description Progression will be determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions.
Time Frame Year 5
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 5 year
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Health-related Quality of Life Among Study Patients by Treatment Arm.
Hide Description [Not Specified]
Time Frame Completion of Treatment
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Health-related Quality of Life Among Study Patients by Treatment Arm .
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Health-related Quality of Life Among Study Patients by Treatment Arm.
Hide Description [Not Specified]
Time Frame 2 year
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Health-related Quality of Life Among Study Patients by Treatment Arm .
Hide Description [Not Specified]
Time Frame 5 year
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Immune Response and Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
14.Secondary Outcome
Title HPV Status- Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 3 months
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Relative Toxicities During Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame End of treatment
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
Time Frame Adverse event data collected from first day of treatment to 30 days post last day of treatment, up to 2 years post treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DCA (Dichloroacetate) Treatment Placebo
Hide Arm/Group Description

DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
All-Cause Mortality
DCA (Dichloroacetate) Treatment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DCA (Dichloroacetate) Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/25 (32.00%)      6/25 (24.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/25 (4.00%)  1 1/25 (4.00%)  1
Anemia  1  0/25 (0.00%)  0 1/25 (4.00%)  1
Cardiac disorders     
Atrial fibrillation  1  0/25 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders     
Vomiting  1  1/25 (4.00%)  1 3/25 (12.00%)  3
Nausea  1  0/25 (0.00%)  0 2/25 (8.00%)  2
Mucositis Oral  1  0/25 (0.00%)  0 1/25 (4.00%)  1
General disorders     
Fatigue  1  1/25 (4.00%)  1 0/25 (0.00%)  0
Fever  1  1/25 (4.00%)  1 0/25 (0.00%)  0
Infections and infestations     
Infection and infestation-Other  1  1/25 (4.00%)  1 0/25 (0.00%)  0
Investigations     
creatinine increased  1  0/25 (0.00%)  0 1/25 (4.00%)  1
Neutrophil count decreased  1  1/25 (4.00%)  1 0/25 (0.00%)  0
Metabolism and nutrition disorders     
dehydration  1  2/25 (8.00%)  2 0/25 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/25 (4.00%)  1 0/25 (0.00%)  0
Psychiatric disorders     
Delirium  1  1/25 (4.00%)  2 0/25 (0.00%)  0
Vascular disorders     
Hypotension  1  1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DCA (Dichloroacetate) Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/25 (100.00%)      25/25 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  23/25 (92.00%)  23 23/25 (92.00%)  23
Febrile Neutropenia  1  2/25 (8.00%)  2 1/25 (4.00%)  1
Ear and labyrinth disorders     
Ear pain  1  0/25 (0.00%)  0 4/25 (16.00%)  4
Hearing Impaired  1  5/25 (20.00%)  5 3/25 (12.00%)  3
Tinnitus  1  15/25 (60.00%)  15 21/25 (84.00%)  21
Eye disorders     
Blurred vision  1  2/25 (8.00%)  2 0/25 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  1  0/25 (0.00%)  0 3/25 (12.00%)  3
Constipation  1  19/25 (76.00%)  19 19/25 (76.00%)  19
Diarrhea  1  6/25 (24.00%)  6 6/25 (24.00%)  6
Dry Mouth  1  22/25 (88.00%)  22 24/25 (96.00%)  24
Dyspepsia  1  9/25 (36.00%)  9 12/25 (48.00%)  12
Dysphagia  1  20/25 (80.00%)  20 22/25 (88.00%)  22
Mucositis oral  1  22/25 (88.00%)  22 23/25 (92.00%)  23
Nausea  1  20/25 (80.00%)  20 20/25 (80.00%)  20
Oral pain  1  7/25 (28.00%)  7 6/25 (24.00%)  6
Vomiting  1  16/25 (64.00%)  16 18/25 (72.00%)  18
General disorders     
Edema Limbs  1  2/25 (8.00%)  2 1/25 (4.00%)  1
Fatigue  1  22/25 (88.00%)  22 23/25 (92.00%)  23
Fever  1  11/25 (44.00%)  11 2/25 (8.00%)  2
pain  1  4/25 (16.00%)  4 3/25 (12.00%)  3
Infections and infestations     
Mucosal infection  1  2/25 (8.00%)  2 2/25 (8.00%)  2
Injury, poisoning and procedural complications     
Dermatitis Radiation  1  17/25 (68.00%)  17 18/25 (72.00%)  18
Investigations     
Alanine aminotransferase increased  1  5/25 (20.00%)  5 5/25 (20.00%)  5
Alkaline Phosphatase Increased  1  2/25 (8.00%)  2 4/25 (16.00%)  4
Aspartate aminotransferase increased  1  5/25 (20.00%)  5 2/25 (8.00%)  2
Creatinine increased  1  7/25 (28.00%)  7 5/25 (20.00%)  5
Lymphocyte count decreased  1  19/25 (76.00%)  19 17/25 (68.00%)  17
Lymphocyte count increased  1  2/25 (8.00%)  2 0/25 (0.00%)  0
Neutrophil count decreased  1  18/25 (72.00%)  18 15/25 (60.00%)  15
Platelet count decreased  1  19/25 (76.00%)  19 9/25 (36.00%)  9
Weight Loss  1  21/25 (84.00%)  21 21/25 (84.00%)  21
White blood cells decreased  1  22/25 (88.00%)  22 19/25 (76.00%)  19
Metabolism and nutrition disorders     
Anorexia  1  23/25 (92.00%)  23 22/25 (88.00%)  22
Dehydration  1  5/25 (20.00%)  5 5/25 (20.00%)  5
Hyperglycemia  1  1/25 (4.00%)  1 4/25 (16.00%)  4
Hyperkalemia  1  1/25 (4.00%)  1 3/25 (12.00%)  3
Hypoalbuminenia  1  12/25 (48.00%)  12 11/25 (44.00%)  11
Hypocalcemia  1  9/25 (36.00%)  9 8/25 (32.00%)  8
Hypoglycemia  1  2/25 (8.00%)  2 1/25 (4.00%)  1
Hypokalemia  1  8/25 (32.00%)  8 8/25 (32.00%)  8
Hypomagnesemia  1  10/25 (40.00%)  10 9/25 (36.00%)  9
Hyponatremia  1  20/25 (80.00%)  20 20/25 (80.00%)  20
Musculoskeletal and connective tissue disorders     
Arthraligia  1  2/25 (8.00%)  2 4/25 (16.00%)  4
Back Pain  1  2/25 (8.00%)  2 2/25 (8.00%)  2
Generalized muscle weakness  1  8/25 (32.00%)  8 10/25 (40.00%)  10
Neck pain  1  2/25 (8.00%)  2 2/25 (8.00%)  2
Nervous system disorders     
Dizziness  1  8/25 (32.00%)  8 5/25 (20.00%)  5
Dysgeusia  1  23/25 (92.00%)  23 24/25 (96.00%)  24
Headache  1  0/25 (0.00%)  0 8/25 (32.00%)  8
Paresthesia  1  2/25 (8.00%)  2 0/25 (0.00%)  0
Peripheral sensory neuropathy  1  14/25 (56.00%)  14 11/25 (44.00%)  11
Tremor  1  6/25 (24.00%)  6 3/25 (12.00%)  3
Psychiatric disorders     
Agitation  1  0/25 (0.00%)  0 2/25 (8.00%)  2
Anxiety  1  9/25 (36.00%)  9 14/25 (56.00%)  14
Insomnia  1  18/25 (72.00%)  18 17/25 (68.00%)  17
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/25 (12.00%)  3 2/25 (8.00%)  2
Dyspnea  1  8/25 (32.00%)  8 7/25 (28.00%)  7
Hiccups  1  3/25 (12.00%)  3 2/25 (8.00%)  2
Hoarseness  1  5/25 (20.00%)  5 4/25 (16.00%)  4
Laryngeal edema  1  3/25 (12.00%)  3 0/25 (0.00%)  0
Postnasal drip  1  1/25 (4.00%)  1 2/25 (8.00%)  2
Sore Throat  1  14/25 (56.00%)  14 16/25 (64.00%)  16
Skin and subcutaneous tissue disorders     
Alopecia  1  7/25 (28.00%)  7 15/25 (60.00%)  15
Rash maculo-papular  1  3/25 (12.00%)  3 0/25 (0.00%)  0
Vascular disorders     
Hot Flashes  1  2/25 (8.00%)  2 1/25 (4.00%)  1
Hypertension  1  10/25 (40.00%)  10 9/25 (36.00%)  9
Hypotension  1  7/25 (28.00%)  7 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Steven Powell
Organization: Sanford Clinical Research
Phone: 605-328-8000
Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT01386632     History of Changes
Other Study ID Numbers: DCA 2010
First Submitted: May 23, 2011
First Posted: July 1, 2011
Results First Submitted: January 18, 2016
Results First Posted: June 14, 2017
Last Update Posted: March 5, 2019