Swallowing impairment in oral cavity cancer patients treated with radiation therapy - current status, its impacts and effects of a swallowing exercise education program

Swallowing Exercise Education Program (SEEP)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15120536

Enrollment

Registered

2017-10-19

Start date

2015-08-01

Completion date

Unknown

Last updated

2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cavity Cancer Patients Cancer Oral Cavity Cancer Patients

Interventions

This study has two parts. The first part of the study is to develop a Swallowing Exercise Program (SEP) to use in the care of patients with oral cavity cancer (in the first 6 months of the first year)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age greater than 20 years and less than 70 years 2. Pathologic confirmation of oral cavity squamous cell carcinoma (OSCC) 3. KPS score of 60 or greater 4. New diagnosis and recurrence of oral cavity cancer and patient awareness of the diagnosis 5. Completion of treatment and status of more than 3 months to 3 years post-treatment 6. Eating Assessment Tool-10 score of 3 or more (3-40 is indicative of swallowing problems)53 and Modified Water Swallowing Test (MWST) levels of I, II, and III;54 6. Disease-free survival, defined as no disease evident in the patient after treatment 7. Agreement to participate in the study after explanation of its purposes and procedures

Exclusion criteria

Exclusion criteria: 1. Current therapy with surgery, RT, or CCRT in oral cavity cancer 2. Any unstable systemic disease (heart disease, hypertension, active infection, or other underlying disease) 3. KPS score of 60 or less 4. Any condition likely to cause discomfort during the research interview

Design outcomes

Primary

Measure	Time frame
Dysphagia-specific health-related QOL is measured using the MD Anderson Dysphagia Inventory (MDADI) at baseline, one, two, three and six months.	—

Secondary

Measure	Time frame
1. Swallowing ability is measured using Sydney Swallowing Questionnaire (SSQ) at baseline, one, two, three and six months 2. Depression is measured using Hospital Anxiety and Depression Scale (HADS)–Depression Subscale at baseline, one, two, three and six months 3. Functional level of oral intake of food and liquid measured using the Functional Oral Intake Scale (FOIS) at baseline, one, two, three and six months 4. Physical performance is measured using the Karnofsky’s performance status index (KPS) at baseline, one, two, three and six months	—

Measure

Time frame

1. Swallowing ability is measured using Sydney Swallowing Questionnaire (SSQ) at baseline, one, two, three and six months 2. Depression is measured using Hospital Anxiety and Depression Scale (HADS)–Depression Subscale at baseline, one, two, three and six months 3. Functional level of oral intake of food and liquid measured using the Functional Oral Intake Scale (FOIS) at baseline, one, two, three and six months 4. Physical performance is measured using the Karnofsky’s performance status index (KPS) at baseline, one, two, three and six months

—

Countries

Taiwan

Contacts

Public ContactShu-Ching Chen

shuching@gw.cgust.edu.tw+886 3 2118999 Ext. 3436

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026