Clinical trial NCT05227807: The Efficacy of Mouth Exercise in Oral Cancer Patients After Receiving Surgery
Official title: The Efficacy of Mouth Exercise for Preventing Trismus in Oral Cancer Patients After Receiving Surgery and Radio or Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: oral cancer
Trismus
Mouth-opening training
Maximum interincisal opening
Follow-up telephone calls
Mandibular function
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Chang Gung Medical Foundation
First posted: 2022-02-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: PURPOSE: The purpose of the study was to investigate the efficacy of mouth-opening training with follow-up on 1st、3rd、6th months for reducing postoperative trismus in patients with oral cancer.

METHODS: The study is a quasi-experimental design using repeated measures. 44 patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited to the control group first then 38 patients were recruited to the intervention group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months and two telephone calls fellow up. Subjects in the intervention group received mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one month, three months, and six months after radiotherapy, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire, Restriction of Mouth Opening Questionnaire, and Difficulty of Food Intake.

Detailed description: The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group.

The study is a quasi-experimental design with repeated measures. A convenience sample of 44 oral cancer patients was recruited to control group the 38 patients was recruited to the intervention group Subjects in the control group received routine care including written mouth exercise instructions. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Patients in the experimental group were provided with two one-on-one oral exercise instruction courses after receiving the last two radiation treatments by nurse practitioner. Subjects in the intervention group received additional 2 follow-up phone calls from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, three-months and six month after radiotherapy, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected.

All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).

Eligibility criteria: Inclusion Criteria:

1. Over 18 years old
2. have a clear consciousness
3. can communicate in Mandarin and Taiwanese
4. diagnosed by a doctor as primary oral cancer (including gums, the floor of the mouth, buccal mucosa, hard palate, and posterior molar area) and
5. undergoing oral cancer tumor resection (including upper lymphatic removal) Those who have undergone skin flap reconstruction
6. radiation and/or concurrent chemotherapy.

Exclusion Criteria:

1. Poor wound healing after surgery and unable to perform the oral movement
2. no incisor or the position of the incisor after surgery is replaced by a flap due to surgery, the maximum opening distance cannot be measured
3. those with lip and tongue cancers that are less related to the closure of the teeth ( Or those who are physically unable to exercise)

Primary outcomes:
measure: MIO( Maximum inter-incisal opening)
timeFrame: Change from pre-intervention and during the intervention on 2, 4, and 6 months
Secondary outcomes:
measure: Restriction of Mouth Opening Questionnaire
timeFrame: Change from pre-intervention and during the intervention on 2, 4, and 6 months
measure: Mandibular Function Impairment Questionnaire
timeFrame: Change from pre-intervention and during the intervention on 2, 4, and 6 months
measure: Exercise Time
timeFrame: each week during the intervention
Other outcomes:
Locations:
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: SuFan Wu, Doctor
role: STUDY_DIRECTOR
References: