Multiple Interactive With Nutrition and Exercise Strategies in Frailty Cancer Patients

Cancer Clinical Trial

Official title:

Department of Nursing, Tzu Chi University, Hualien, Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654637
• Other study ID #: TCU-CHHuang
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2020
• Source: Tzu Chi University
• Contact: Chu Hou Huang, PhD
• Phone: 886-3-565301
• Email: hou2017[@]gms.tcu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Due to the changes in lifestyle caused by the COVID-19, it is a priority to provide multi-interactive digital platforms and social media for nutrition and exercise programs for cancer patients. A two-year serial program uses mixed study methods of longitudinal combined experimental study. We will investigate cancer frailty's current situation and track the frailty trends after cancer patients received different treatments. We will also invite experts to develop multi-interactive digital platforms of nutrition and performance-based tailored circuit training programs according to the cancer frailty survey. We will recruit 20-85 years of newly diagnosed or first-time recurrence cancer patients and stratified randomization assigned to evaluate nutrition and physical exercise intervention effectiveness. The measure indicators were treatment-related adverse events, nutritional status, frailty status, survival rate, and life quality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Aged from 20-85 years with histological confirmation malignancy.
• Requiring treatment by surgery, chemotherapy, hormonotherapy, radiotherapy, or targeted therapy with a curative intention as estimated by oncologists.
• First diagnosed or recurrence of head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma.

Exclusion Criteria:

• Non-head and neck cancer, esophageal cancer, colon/rectum cancer, lung cancer, AML, ALL, lymphoma, multiple myeloma with first diagnosis or recurrence patients.
• Eastern Cooperative Oncology Group test score>2.
• Serious psychiatric or cognitive problems, and functional disability leading to a total inability to walk.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Nutrition and Exercise Strategies
Multiple Interactive with Nutrition and Exercise Strategies

Locations

Country	Name	City	State
Taiwan	Tzu Chi University	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Tzu Chi University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survival	from diagnosed to the dead date	The OS was calculated from the date of diagnosis to the date of death or was censored at the date of the last follow-up (3 years from diagnosed) for surviving patients.
Primary	Frailty trend	After treatment frailty condition	After treatment three-month
Secondary	Treatment-related adverse events	CTCAE or Clavien-Dindo classification	After treatment one month