A Phase 3 interventional study of pilocarpine hydrochloride and Placebo in Head and Neck Cancer and Oral Complications, sponsored by Radiation Therapy Oncology Group. Completed at 232 sites in 2 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Supportive care
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).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 249 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
5mg pilocarpine hydrochloride tablets commencing 3 days prior to irradiation
Drug: pilocarpine hydrochloride
Placebo tablets commencing 3 days prior to irradiation
Other: Placebo
5mg pilocarpine hydrochloride tablets
Acute salivary gland toxicity
Time frame: From the start of treatment to 13 weeks
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
Showing the first 100 of 232 sites across 2 countries.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Radiation Therapy Oncology Group