An observational study of changes in exercise capacity associated with long hospitalization in patients with lung, esophageal, and head and neck cancer undergoing radiotherapy and chemoradiotherapy -Pilot study-

UMIN ID: UMIN000044944

Registered date:23/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer, esophageal cancer, head and neck cancer
• Date of first enrollment: 2021/07/26
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Proportion and characteristics of patients who decreased exercise capacity beyond minimal clinically important difference (a decrease of more than -40 m in the 6-minute walk test) between the start of irradiation and 4-8 weeks after the start of irradiation.
• Secondary Outcome: Relationship between exercise capacity and physical activity, sarcopenia, fatigue, cachexia, and quality of life, and these changes.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) They are hospitalized only during chemotherapy 2) Stereotactic body radiation therapy is scheduled. 3) RT/CRT as adjuvant therapy before and after surgery 4) Diagnosis of unstable angina or myocardial infarction within 1 month prior to enrollment 5) Having bone metastases with limited exercise by doctor 6) Having psychosis or neurological symptoms that make it difficult to administer the questionnaire accurately 7) Determined by the doctor to be ineligible for enrollment in this study

Related Information

• Primary Sponsor: Shizuoka Cancer Center
• Source(s) of Monetary Support: None