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
| Autor: | Nancy M. Lee, David G Bachman, D.I. Hodson, Ruby F. Meredith, Marvin Rotman, Robert L. Foote, Jacquelyn Fisher, Charles E. Scott, Charles W. Scarantino, Fran G Leveque, Robert L. White |
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| Rok vydání: | 2003 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Saliva Psychometrics Muscarinic Agonists Placebo Xerostomia law.invention Swallowing Quality of life Randomized controlled trial law Surveys and Questionnaires Internal medicine medicine Mucositis Humans Radiology Nuclear Medicine and imaging Karnofsky Performance Status Radiation business.industry Head and neck cancer Pilocarpine Radiotherapy Dosage Middle Aged medicine.disease Surgery Clinical trial Oncology Head and Neck Neoplasms Quality of Life Female business |
| Zdroj: | International Journal of Radiation Oncology*Biology*Physics. 56:832-836 |
| ISSN: | 0360-3016 |
| DOI: | 10.1016/s0360-3016(03)00121-4 |
| Popis: | Purpose To determine whether prevention of hyposalivation after curative radiotherapy (RT) to the head and neck improves patients' quality of life (QOL). Methods and materials Patients were to receive at least 50 Gy to 50% of the volume of the major salivary glands, provide unstimulated and stimulated saliva samples, and complete the University of Washington head-and-neck QOL tool before RT and 3 and 6 months after RT. Patients were randomized to receive pilocarpine 5 mg or placebo q.i.d. Results A total of 249 patients was randomized between March 1998 and January 2000. Of these, 214 were eligible for QOL analysis. Patients were evenly distributed between arms by race, gender, tobacco use, tumor site, T stage (50% T2-T3), and salivary function. A Karnofsky performance status of 90% was more common in the pilocarpine arm. Twenty percent of the patients on the pilocarpine arm and 29% of the patients on the placebo arm were taking nutritional supplements. The placebo arm patients had greater mouth pain and chewing difficulties. Compliance for the QOL tool at 3 and 6 months was 65% and 50%, respectively. Despite statistically significant ( p = 0.047 and p = 0.049, respectively) preservation of salivary function in the pilocarpine arm, patients on the pilocarpine arm reported difficulties with swallowing (75%), activity (80%), hyposalivation (64%), and taste (81%). No difference was noted between arms at 3 months in mucositis scores, with both arms demonstrating increased requirement for oral nutrients. Conclusion Objective prevention of hyposalivation did not affect patients' assessment of salivary function or QOL because of the greater impact mucositis plays in QOL after RT. |
| Databáze: | OpenAIRE |
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