RTOG Protocol No: 9607	Protocol Status:
	Opened:	July 4, 1997
	Closed:	April 30, 1999

Title: A Phase II Study of Radioprotection of Oral And Pharyngeal Mucosa By The Prostaglandin E₁ Analog Misoprostol

Patient Population:
- Intact cancer of the oral cavity, oropharynx, supraglottic larynx, hypopharynx or nasopharyx, T₁-T₂, N₀-N₁.
- Completely resected margin-negative cancers of the oral cavity, oropharynx, supraglottic larynx or hypopharynx T₁-T₃, N₀-N_1.
- Planned irradiation of the oral cavity, pharynx or both at 2 Gy per day to total doses of 60 to 70 Gy over 6 to 7 weeks.
- No previous head and neck cancer or other malignancy (except skin cancer) except locally excised T1 N0 cancer NED after two years.
- No previous head and neck irradiation.
- No previous or concurrent chemotherapy.
- Women of child bearing age must not be pregnant and must use efficient contraception during treatment.
- KPS > 60, age > 18.
- Patients may not be registered on another treatment study using RT or chemotherapy.
- Signed study-specific informed consent.

Objectives:

To determine if misoprostol protects mucous membranes from the acute effects of irradiation, and to evaluate quality of life outcomes.

Schema:

R E G I S T E R	Option 1:	Post Op XRT and Misoprostol (120 ± 15 mins before irradiation)
	Option 2:	XRT only and Misoprostol (120 ± 15 mins before irradiation)

Study Chairs:	James E. Marks, M.D.	Total Patients Entered: 33
	Wayne R. Hanson, M.D.

Reference: Johnson D, Scott C, et al. Assessment of Quality of Life and Oral Function of Patients Participating in a Phase II Study of Radioprotection of Oral and Pharyngeal Mucosa by the Prostaglandin E1 Analog Misoprostol (RTOG 96-07). Int J Radiat Onco Biol Phys 54:1455-1459, 2002.

Purpose: The oral complications associated with radiotherapy to the head and neck are a significant dose-limiting factor. The goals of this study were to determine whether oropharyngeal rinsing and ingestion of misoprostol protect mucous membranes from the acute effects of irradiation, and to evaluate the quality-of-life (QOL) outcomes of patients receiving misoprostol. We report the results of the QOL outcomes of patients in this study.

Methods and Materials: A total of 33 patients with resected or intact cancer of the oral cavity, oropharynx, supraglottic larynx, or hypopharynx were registered to receive postoperative radiotherapy plus misoprostol or primary radiotherapy plus misoprostol. All patients were scheduled to receive 60-70 Gy at 2 Gy/d within 6-7 weeks. QOL and function were evaluated.

Results: A decrease in the QOL and function occurred in all areas covered by the questionnaire at the 6-week interval. This decrease was significant for eating, saliva, taste, and mucous. Of these significant factors, taste, saliva, and mucous consistency had not resolved by 12 weeks.

Conclusion: Increased understanding of the impact of treatment on QOL and symptoms will formulate the rational design of toxicity interventions and enhance the multidisciplinary care of head-and-neck patients.