The purposes of this double-blind randomized clinical trial are to: 1) test the effectiveness of two arms in preventing chemotherapy (CTX)-induced oral mucositis in persons with cancer who are receiving mucositis-producing CTX agents; 2) test the effectiveness of three arms in treating CTX-induced oral mucositis; and 3) determine the impact of the prevention and treatment arms on direct and indirect indices of CTX-induced oral mucositis morbidity. Theories of physiology/pathophysiology, and self-care provide the conceptual framework. All patients will carry out a nurse-initiated systematic oral hygiene teaching program: PRO-SELF:Mouth Aware (PSMA). Random assignment will occur at two stages: prior to the development of CTX-induced oral mucositis (Stage 1) and with the occurrence of CTX-induced oral mucositis (Stage 2). In Stage 1, 448 outpatients, initiating mucositis-producing CTX, will be followed over 3 cycles of chemotherapy. The 448 patients will be assigned to either A) PSMA + Sterile Water mouthwash B.I.D.; or B) PSMA + Chlorhexidine mouthwash B.I.D. Patients who do not develop oral mucositis will come off study at the completion f the third CTX cycle. Patients who develop CTX-induced oral mucositis anytime during the 3 cycles of CTX (estimated 44%) will be randomized to one of the three arms of Stage 2 and followed for an additional 3 cycles of CTX. The treatment arms include: A2) Salt and Soda, B2) """"""""Magic Mouthwash"""""""" [Lidocaine viscous solution, Diphenhydramine hydrochloride, (Benadryl), Aluminum Hydroxide suspension, Maalox.], and C2) Chlorhexidine. All Stage 2 treatment arms include the PSMA. Nineteen referral sites will be used for this study. Morbidity, the dependent variable, will include measures of: the incidence, time to onset, time to heal, severity, and pain of CTX-induced mucositis. In addition, infection and problems with ingestion of food and fluid will be measured. Data will be analyzed using repeated measures multivariate techniques. The study findings will answer important questions on the prevention and treatment of CTX-induced mucositis and related morbidity.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA055555-02
Application #
3200051
Study Section
Nursing Research Study Section (NURS)
Project Start
1992-08-17
Project End
1995-07-31
Budget Start
1993-08-01
Budget End
1994-07-31
Support Year
2
Fiscal Year
1993
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Type
Schools of Nursing
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Dodd, M J; Miaskowski, C; Dibble, S L et al. (2000) Factors influencing oral mucositis in patients receiving chemotherapy. Cancer Pract 8:291-7
Dodd, M J; Dibble, S L; Miaskowski, C et al. (2000) Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 90:39-47
Dodd, M J; Miaskowski, C; Shiba, G H et al. (1999) Risk factors for chemotherapy-induced oral mucositis: dental appliances, oral hygiene, previous oral lesions, and history of smoking. Cancer Invest 17:278-84