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Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00656513
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Head and Neck Cancer
Xerostomia
Interventions: Drug: Pilocarpine
Procedure: ALTENS

  Participant Flow

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
No text entered.

Reporting Groups
  Description
ALTENS: Phase II Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Pilocarpine: Phase III 5mg pilocarpine by mouth 3 times a day for 12 weeks
ALTENS: Phase III Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit

Participant Flow:   Overall Study
    ALTENS: Phase II   Pilocarpine: Phase III   ALTENS: Phase III
STARTED   48   73   75 
COMPLETED   44 [1]   43 [1]   53 [1] 
NOT COMPLETED   4   30   22 
Protocol Violation                1                0                2 
Withdrawal by Subject                0                11                4 
Death                0                0                1 
Missing data                0                11                9 
Incomplete treatment                3                0                0 
Treatment completed outside of timeframe                0                3                1 
Missing baseline form                0                5                5 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  Baseline Characteristics

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.
Eligible patients (i.e. without protocol violation)

Reporting Groups
  Description
ALTENS: Phase II Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Pilocarpine: Phase III 5mg pilocarpine by mouth 3 times a day for 12 weeks
ALTENS: Phase III Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Total Total of all reporting groups

Baseline Measures
   ALTENS: Phase II   Pilocarpine: Phase III   ALTENS: Phase III   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   73   73   193 
Age 
[Units: Years]
Median (Full Range)
 60 
 (24 to 80) 
 59 
 (29 to 78) 
 58 
 (42 to 83) 
 58 
 (24 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      7  14.9%      10  13.7%      11  15.1%      28  14.5% 
Male      40  85.1%      63  86.3%      62  84.9%      165  85.5% 


  Outcome Measures

1.  Primary:   Phase II: Treatment Compliance (Number of Compliant Patients)   [ Time Frame: Randomization to 12 weeks ]

2.  Primary:   Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months   [ Time Frame: Baseline (randomization) and 9 months ]

3.  Secondary:   Phase II: Pecentage of Patients With Beneficial Treatment Response   [ Time Frame: Pre-treatment and 6 months from registration ]

4.  Secondary:   Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III)   [ Time Frame: Baseline, 4, 6, and 15 months from randomization ]

5.  Secondary:   Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III)   [ Time Frame: Baseline, 4, 6, 9 and 15 months from randomization ]

6.  Secondary:   Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)   [ Time Frame: Baseline, 4, 6, 9 and 15 months from randomization ]

7.  Secondary:   Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)   [ Time Frame: Pre-treatment to 4, 6, 9 and 15 months from randomization ]

8.  Secondary:   Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III   [ Time Frame: Baseline and 9 months from randomization. ]


  Serious Adverse Events


  Other Adverse Events

Time Frame No text entered.
Additional Description Adverse events are reported for all eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
ALTENS: Phase II Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Pilocarpine: Phase III 5mg pilocarpine by mouth 3 times a day for 12 weeks
ALTENS: Phase III Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit

Other Adverse Events
    ALTENS: Phase II   Pilocarpine: Phase III   ALTENS: Phase III
Total, Other (not including serious) Adverse Events       
# participants affected / at risk   7/47 (14.89%)   51/73 (69.86%)   27/72 (37.50%) 
Ear and labyrinth disorders       
Tinnitus * 1       
# participants affected / at risk   0/47 (0.00%)   4/73 (5.48%)   2/72 (2.78%) 
Eye disorders       
Vision blurred * 1       
# participants affected / at risk   0/47 (0.00%)   5/73 (6.85%)   0/72 (0.00%) 
Gastrointestinal disorders       
Constipation * 1       
# participants affected / at risk   0/47 (0.00%)   4/73 (5.48%)   1/72 (1.39%) 
Diarrhea * 1       
# participants affected / at risk   0/47 (0.00%)   5/73 (6.85%)   1/72 (1.39%) 
Dry mouth * 1       
# participants affected / at risk   5/47 (10.64%)   22/73 (30.14%)   18/72 (25.00%) 
Dysphagia * 1       
# participants affected / at risk   1/47 (2.13%)   10/73 (13.70%)   9/72 (12.50%) 
General disorders       
Chills * 1       
# participants affected / at risk   0/47 (0.00%)   5/73 (6.85%)   0/72 (0.00%) 
Fatigue * 1       
# participants affected / at risk   1/47 (2.13%)   7/73 (9.59%)   6/72 (8.33%) 
Localized edema [head and neck] * 1       
# participants affected / at risk   0/47 (0.00%)   1/73 (1.37%)   4/72 (5.56%) 
Musculoskeletal and connective tissue disorders       
Neck pain * 1       
# participants affected / at risk   0/47 (0.00%)   3/73 (4.11%)   4/72 (5.56%) 
Nervous system disorders       
Dizziness * 1       
# participants affected / at risk   0/47 (0.00%)   5/73 (6.85%)   3/72 (4.17%) 
Headache * 1       
# participants affected / at risk   0/47 (0.00%)   14/73 (19.18%)   2/72 (2.78%) 
Taste alteration * 1       
# participants affected / at risk   1/47 (2.13%)   5/73 (6.85%)   4/72 (5.56%) 
Psychiatric disorders       
Insomnia * 1       
# participants affected / at risk   0/47 (0.00%)   4/73 (5.48%)   2/72 (2.78%) 
Renal and urinary disorders       
Urinary frequency * 1       
# participants affected / at risk   0/47 (0.00%)   5/73 (6.85%)   0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis * 1       
# participants affected / at risk   0/47 (0.00%)   8/73 (10.96%)   2/72 (2.78%) 
Skin and subcutaneous tissue disorders       
Skin induration * 1       
# participants affected / at risk   0/47 (0.00%)   3/73 (4.11%)   6/72 (8.33%) 
Sweating * 1       
# participants affected / at risk   0/47 (0.00%)   24/73 (32.88%)   0/72 (0.00%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, CTCAE (3.0)



  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00656513     History of Changes
Other Study ID Numbers: RTOG-0537
CDR0000592644
First Submitted: April 10, 2008
First Posted: April 11, 2008
Results First Submitted: June 22, 2017
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017