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

Reviewer: Heather Jones, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 17, 2002

Presenter: Jacquelyn J Fisher
Presenter's Affiliation: RTOG
Type of Session: Scientific


    When radiation therapy treatment fields include the major salivary glands, many patients will experience dryness of the oral mucosa during the first 1 or 2 weeks of treatment. Not only is the quantity of saliva reduced, but its composition and physical properties are changed as well. Without appropriate management, this problem can lead to progressive deterioration of the teeth, mucosa, gingiva, and mandible. This study evaluated the effects of Pilocarpine intervention and its effect on QoL

Materials and Methods

  • Eligible patients had to have received at least 50 Gy to 50% of the volume of the major salivary glands
  • Each patiet provided unstimulated and stimulated saliva samples
  • The Univ. of Washington H&N QoL tool (HNSS) was administered prior to RT, and 3 mo., and 6 mo. post-RT.
  • Patients were randomized to receive Pilocarpine (P) 5mg qid or placebo at the start of RT.
  • 249 patients were randomized between 3/98 to 1/00, 246 were eligible for analysis for QoL.


  • The groups were evenly distributed between the two arms by race, gender, tobacco use, tumor site, and T-stage (50% T2/T3) and salivary function
  • 20% of pts on the treatment arm used oral supplements while 29% patients on the placebo arm were on oral supplements
  • Oral supplements impacted employment, activity, eating, and mucosal complaints.
  • Placebo arm patients had greater mouth pain and chewing difficulties.
  • Compliance for HNSS was 75% at 3 mo. and 50% at 6 mo.
  • There was no difference between treatment arms in any of the HNSS (taste impairment, activity, pain) at 3 mo. or 6 mo. despite statistically significant (p=0.047 and p=0.049 respectively) preservation of salivary function in the treatment arm, and continued functional loss in the placebo arm
  • Patients on the treatment arm reported difficulties with swallowing (75%), activity (80%), hyposalivation (64%), and taste (81%).

Author's Conclusions

    The authors felt that the objective prevention of hyposalivation did not affect patients' assessment of salivary function or QoL due to the greater impact mucositis plays in QOL post-RT.

Clinical/Scientific Implications

    This study highlights the difficulty one faces when attempting to measure a patient?s QoL. One major problem is the number of instruments available to an investigator. In this study it may well be that the instrument chosen was not sensitive enough to distinguish mucositis and xerostomia. It may have been more prudent in this situation to use more than one scale to ascertain QoL.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.