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Trial record 91 of 1202 for:    Oral Cancer | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003139
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : November 17, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Complications Drug: pilocarpine hydrochloride Other: Placebo Phase 3

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Study Start Date : March 1998
Actual Primary Completion Date : January 2001
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pilocarpine hydrocloride
5mg pilocarpine hydrochloride tablets commencing 3 days prior to irradiation
Drug: pilocarpine hydrochloride
5mg pilocarpine hydrochloride tablets

Placebo Comparator: Placebo
Placebo tablets commencing 3 days prior to irradiation
Other: Placebo

Primary Outcome Measures :
  1. Acute salivary gland toxicity [ Time Frame: From the start of treatment to 13 weeks ]

Secondary Outcome Measures :
  1. Acute mucositis in the pharynx, palate, tongue, or buccal [ Time Frame: From the start of treatment to 13 weeks ]
  2. 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 ]
  3. Effects of continuing pilocarpine out to 6 months from the start of treatment [ Time Frame: From the start of treatment to 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003139

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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
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Study Chair: Francis G. LeVeque, DDS Barbara Ann Karmanos Cancer Institute

Publications of Results:
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.

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Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00003139    
Other Study ID Numbers: RTOG-9709
First Posted: September 6, 2004    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Radiation Therapy Oncology Group:
oral complications
lip and oral cavity squamous cell carcinoma
oropharyngeal squamous cell carcinoma
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action