Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 18 and over NCI RTOG-9709 NCI-P97-0121, NCT00003139

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.

Entry Criteria

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

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

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 

Expected Enrollment

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

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.

Scarantino C, LeVeque F, Swann RS, et al.: Effect of pilocarpine during radiation therapy: results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. J Support Oncol 4 (5): 252-8, 2006.[PUBMED Abstract]

Fisher J, Scott C, Scarantino CW, et al.: Phase III quality-of-life study results: impact on patients' quality of life to reducing xerostomia after radiotherapy for head-and-neck cancer--RTOG 97-09. Int J Radiat Oncol Biol Phys 56 (3): 832-6, 2003.[PUBMED Abstract]

Fisher JJ, Scott CB, Scarantino CW, et al.: Phase III quality of life (Qol) study: reduction in hyposalivation does not improve Qol for head and neck (H&N) cancer patients post radiation therapy (P-RT). RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1423, 2002.

Scarantino CW, Leveque FG, Scott CB, et al.: A phase III study of concomitant oral pilocarpine to reduce hypo-salivation and mucositis associated with curative radiation therapy (RT) in the head and neck (H&N) cancer patients. RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-897, 225a, 2001.

Scarantino CW, Leveque F, Scott C, et al.: A phase III study on the concurrent use of oral pilocarpine to reduce hyposalivation and mucositis associated with radiation therapy in head and neck cancer patients: final results of RTOG 97-09. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-157, 85-86, 2001.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Francis LeVeque, DDS, Protocol chair		Ph: 313-745-9300; 800-527-6266

Registry Information
Official Title		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
Trial Start Date		1998-03-17
Registered in ClinicalTrials.gov		NCT00003139
Date Submitted to PDQ		1997-11-11
Information Last Verified		2006-05-30