A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum

Julie Killerup Kaae*, Lone Stenfeldt, Birgitte Hyrup, Carsten Brink, Jesper Grau Eriksen

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Background and purpose: Xerostomia is frequently reported after radiotherapy (RT) for head and neck cancer (HNC). The aim of this study was to reduce symptoms of radiation-induced xerostomia in HNC survivors, in which the experimental arm used chewing gum for a month. Primary endpoint was changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms. Materials and methods: Participants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum were, for a month, randomized (2:1) to: (Arm A) daily chewing gum or (Arm B) standard care. Xerostomia-related QOL was assessed using EORTC QLQ-H&N35 and GRIX questionnaires along with measurement of salivary flow and viscosity at inclusion and after one month. The study was registered on ClinicalTrials.gov (NCT03302676). Results: Ninety-one participants were eligible for analysis (Arm A, n = 55; Arm B, n = 36). Comparing categorized scores for symptoms between arms, reduction of dry mouth was significantly higher for Arm A than Arm B (p = 0.05). A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms. Salivary flow increased and viscosity decreased upon five minutes of stimulation within both arms (p < 0.001, respectively), however no significantly difference was observed between arms. Conclusion: Categorized scores found reduction of dry mouth to be significantly higher in Arm A than Arm B, but no difference was seen for salivary flow rate and viscosity.

OriginalsprogEngelsk
TidsskriftRadiotherapy and Oncology
ISSN0167-8140
DOI
StatusE-pub ahead of print - 9. okt. 2019

Fingeraftryk

Chewing Gum
Xerostomia
Viscosity
Head and Neck Neoplasms
Gingiva

Citer dette

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title = "A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum",
abstract = "Background and purpose: Xerostomia is frequently reported after radiotherapy (RT) for head and neck cancer (HNC). The aim of this study was to reduce symptoms of radiation-induced xerostomia in HNC survivors, in which the experimental arm used chewing gum for a month. Primary endpoint was changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms. Materials and methods: Participants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum were, for a month, randomized (2:1) to: (Arm A) daily chewing gum or (Arm B) standard care. Xerostomia-related QOL was assessed using EORTC QLQ-H&N35 and GRIX questionnaires along with measurement of salivary flow and viscosity at inclusion and after one month. The study was registered on ClinicalTrials.gov (NCT03302676). Results: Ninety-one participants were eligible for analysis (Arm A, n = 55; Arm B, n = 36). Comparing categorized scores for symptoms between arms, reduction of dry mouth was significantly higher for Arm A than Arm B (p = 0.05). A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms. Salivary flow increased and viscosity decreased upon five minutes of stimulation within both arms (p < 0.001, respectively), however no significantly difference was observed between arms. Conclusion: Categorized scores found reduction of dry mouth to be significantly higher in Arm A than Arm B, but no difference was seen for salivary flow rate and viscosity.",
keywords = "Head and neck cancer, Late morbidity, Quality of life, Radiotherapy, Xerostomia",
author = "Kaae, {Julie Killerup} and Lone Stenfeldt and Birgitte Hyrup and Carsten Brink and Eriksen, {Jesper Grau}",
year = "2019",
month = "10",
day = "9",
doi = "10.1016/j.radonc.2019.09.013",
language = "English",
journal = "Radiotherapy & Oncology",
issn = "0167-8140",
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A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum. / Kaae, Julie Killerup; Stenfeldt, Lone; Hyrup, Birgitte; Brink, Carsten; Eriksen, Jesper Grau.

I: Radiotherapy and Oncology, 09.10.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum

AU - Kaae, Julie Killerup

AU - Stenfeldt, Lone

AU - Hyrup, Birgitte

AU - Brink, Carsten

AU - Eriksen, Jesper Grau

PY - 2019/10/9

Y1 - 2019/10/9

N2 - Background and purpose: Xerostomia is frequently reported after radiotherapy (RT) for head and neck cancer (HNC). The aim of this study was to reduce symptoms of radiation-induced xerostomia in HNC survivors, in which the experimental arm used chewing gum for a month. Primary endpoint was changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms. Materials and methods: Participants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum were, for a month, randomized (2:1) to: (Arm A) daily chewing gum or (Arm B) standard care. Xerostomia-related QOL was assessed using EORTC QLQ-H&N35 and GRIX questionnaires along with measurement of salivary flow and viscosity at inclusion and after one month. The study was registered on ClinicalTrials.gov (NCT03302676). Results: Ninety-one participants were eligible for analysis (Arm A, n = 55; Arm B, n = 36). Comparing categorized scores for symptoms between arms, reduction of dry mouth was significantly higher for Arm A than Arm B (p = 0.05). A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms. Salivary flow increased and viscosity decreased upon five minutes of stimulation within both arms (p < 0.001, respectively), however no significantly difference was observed between arms. Conclusion: Categorized scores found reduction of dry mouth to be significantly higher in Arm A than Arm B, but no difference was seen for salivary flow rate and viscosity.

AB - Background and purpose: Xerostomia is frequently reported after radiotherapy (RT) for head and neck cancer (HNC). The aim of this study was to reduce symptoms of radiation-induced xerostomia in HNC survivors, in which the experimental arm used chewing gum for a month. Primary endpoint was changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms. Materials and methods: Participants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum were, for a month, randomized (2:1) to: (Arm A) daily chewing gum or (Arm B) standard care. Xerostomia-related QOL was assessed using EORTC QLQ-H&N35 and GRIX questionnaires along with measurement of salivary flow and viscosity at inclusion and after one month. The study was registered on ClinicalTrials.gov (NCT03302676). Results: Ninety-one participants were eligible for analysis (Arm A, n = 55; Arm B, n = 36). Comparing categorized scores for symptoms between arms, reduction of dry mouth was significantly higher for Arm A than Arm B (p = 0.05). A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms. Salivary flow increased and viscosity decreased upon five minutes of stimulation within both arms (p < 0.001, respectively), however no significantly difference was observed between arms. Conclusion: Categorized scores found reduction of dry mouth to be significantly higher in Arm A than Arm B, but no difference was seen for salivary flow rate and viscosity.

KW - Head and neck cancer

KW - Late morbidity

KW - Quality of life

KW - Radiotherapy

KW - Xerostomia

UR - http://www.scopus.com/inward/record.url?scp=85073054201&partnerID=8YFLogxK

U2 - 10.1016/j.radonc.2019.09.013

DO - 10.1016/j.radonc.2019.09.013

M3 - Journal article

JO - Radiotherapy & Oncology

JF - Radiotherapy & Oncology

SN - 0167-8140

ER -