Effects of an integrated supportive program on xerostomia and saliva characteristics in patients with head and neck cancer radiated with a low dose to the major salivary glands: a randomized controlled trial

Abstract

Abstract Background Xerostomia and changes in saliva characteristics are common side-effects in patients with head and neck cancer (HNC) undergoing radiotherapy, which negatively impact their oral health. However, there are no consensus standards for intervention to manage these problems. The aim of this study was to determine the effect of an integrated supportive program on xerostomia and saliva characteristics at a 1-year follow-up of patients with HNC radiated with a low dose to the major salivary glands. Methods The CONSORT guidelines for a randomized controlled trial were used. Participants with a low overall dose to major salivary glands were randomly allocated to an intervention group (n = 47) or a control group (n = 45). The intervention group received usual care and an integrated supportive program, which included three steps: face-to-face education; face-to-face coaching at 1 month post-radiotherapy; and four telephone coaching sessions at 2, 3, 6, and 9 months post-radiotherapy. The face-to-face education consisted of oral hygiene instruction, oral self-care strategies, facial and tongue muscle exercises, and salivary gland massage. Adherence to the intervention was evaluated using a questionnaire completed during the 9 months follow-up. The control group received usual care. The unstimulated saliva flow rate and xerostomia were assessed in both groups. Results A total of 79 participants (40 in the intervention group and 39 in the control group) completed the 12 months follow-up. The intervention group achieved significantly greater relief from xerostomia than the control group after 3 months (intervention group: 35.1 ± 5.9 versus control group: 38.0 ± 5.9, P = 0.027) and 12 months follow-up (intervention group: 18.5 ± 4.1 versus control group: 22.8 ± 4.3, P < 0.001). A higher unstimulated saliva flow rate was observed in the intervention group than the control group at 12 months follow-up (intervention group: 0.16 ± 0.08 versus control group: 0.12 ± 0.07, P = 0.035). Adherence to the intervention was generally good. Conclusion This integrated supportive program with good adherence relieved xerostomia and had a positive effect on unstimulated saliva flow rate among patients with HNC radiated with a low dose to the major salivary glands during the 12 months of follow-up. Trial registration: Chinese Clinical Trial Registry ChiCTR2100051876 (08/10/2021), retrospectively registered.