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NCT00656513 · ClinicalTrials.gov registry record · Phase 2
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT00656513: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00656513 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656513, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study Summary
RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer. PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
Primary Outcome
Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming's two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 p
Interventions
- DRUG Pilocarpine
- PROCEDURE ALTENS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2008-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT00656513 record still lists
NCT00656513 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Pilocarpine is the first listed.
NCT00656513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656513 about?
NCT00656513 is a clinical study titled "Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer". RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer. PU...
What is the current status of trial NCT00656513?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2008-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00656513?
The interventions under investigation include: Pilocarpine (DRUG), ALTENS (PROCEDURE).
Who is sponsoring clinical trial NCT00656513?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656513's enrollment target sits among peer trials
196 349th of 2000 higher than 1,651 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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