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

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ClinicalTrials.gov Identifier: NCT00003139
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

November 1, 1999
September 6, 2004
November 17, 2015
March 1998
January 2001   (Final data collection date for primary outcome measure)
Acute salivary gland toxicity [ Time Frame: From the start of treatment to 13 weeks ]
Not Provided
Complete list of historical versions of study NCT00003139 on ClinicalTrials.gov Archive Site
  • Acute mucositis in the pharynx, palate, tongue, or buccal [ Time Frame: From the start of treatment to 13 weeks ]
  • Quality of life as measured by the University of Washington Head and Neck Symptom questionnaire [ Time Frame: Pretreatment to 26 weeks from the start of treatment ]
  • Effects of continuing pilocarpine out to 6 months from the start of treatment [ Time Frame: From the start of treatment to 26 weeks ]
Not Provided
Not Provided
Not Provided
 
Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
A Phase III Study to Test the Efficacy of the Prophylactic Use of Oral Pilocarpine to Reduce Hyposalivation and Mucositis Associated With Curative Radiation Therapy in Head and Neck Cancer Patients

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.

OBJECTIVES: I. Determine whether prophylactic use of pilocarpine can shelter unstimulated and stimulated whole salivary flow in patients with head and neck cancer. II. Determine whether prophylactic use of pilocarpine can moderate xerostomia in these patients. III. Determine whether prophylactic use of pilocarpine can reduce the grade and duration of radiation induced mucositis in these patients. IV. Evaluate quality of life outcomes between patients receiving pilocarpine versus placebo. V. Evaluate the impact of xerostomia on patients receiving irradiation to the head and neck.

OUTLINE: This is a randomized, double blind study. Patients receive a central axis midplane dose of radiotherapy five days per week over 6 to 7 weeks. Oral pilocarpine or placebo is administered beginning 3 days prior to radiotherapy, one tablet four times per day for three months. A tablet will be taken 45-60 minutes before radiotherapy. After three months, and after a 3-4 day rest period, all patients receive non blinded pilocarpine for an additional three month period. Patients are followed at weeks 4, 13, and 26 after the start of radiotherapy.

PROJECTED ACCRUAL: A total of 244 patients will be accrued (122 per treatment arm).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
  • Head and Neck Cancer
  • Oral Complications
  • Drug: pilocarpine hydrochloride
    5mg pilocarpine hydrochloride tablets
  • Other: Placebo
  • Experimental: Pilocarpine hydrocloride
    5mg pilocarpine hydrochloride tablets commencing 3 days prior to irradiation
    Intervention: Drug: pilocarpine hydrochloride
  • Placebo Comparator: Placebo
    Placebo tablets commencing 3 days prior to irradiation
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
Not Provided
October 2002
January 2001   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically proven oral cavity and/or oropharyngeal squamous cell carcinoma Radiation volume to encompass at least 50% of parotid glands and have at least 50 Gy delivered to that volume via external beam No salivary gland malignancies or diseases

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Effective contraceptive method must be used during study No pilocarpine allergy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head or neck Surgery: Not specified Other: No concurrent adrenergic antagonists, cholinergic drugs, anti-cholinergics, or tricyclics

Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00003139
RTOG-9709
CDR0000065912
NCI-P97-0121
Yes
Not Provided
Not Provided
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Francis G. LeVeque, DDS Barbara Ann Karmanos Cancer Institute
Radiation Therapy Oncology Group
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP