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Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer

NCT00003139 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2015-11-17

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy. It is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.

PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.

Conditions

Interventions

DRUG

pilocarpine hydrochloride

5mg pilocarpine hydrochloride tablets

OTHER

Placebo

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Francis G. LeVeque, DDS · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-31
Primary Completion
2001-01-31
Completion
2002-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003139 on ClinicalTrials.gov