Multiple Interactive With Nutrition and Exercise Strategies in Frailty Cancer Patients

Not Applicable

• Conditions: Cancer
• Interventions: Behavioral: Nutrition and Exercise Strategies

• Registration Number: NCT04654637
• Lead Sponsor: Tzu Chi University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-03
• Last Update Submitted: 2020-12-03
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm A	Nutrition and Exercise Strategies	fix model of cycle exercise(online supervise) and routine nutrition consult
Arm D	Nutrition and Exercise Strategies	individualize cycle exercise(online supervise) and online nutrition consult
Arm C	Nutrition and Exercise Strategies	individualize cycle exercise(online supervise) and routine nutrition consult
Arm B	Nutrition and Exercise Strategies	fix model of cycle exercise(online supervise) and online nutrition consult

Primary Outcome Measures

Name	Time	Method
Frailty trend	After treatment three-month	After treatment frailty condition

Secondary Outcome Measures

Name	Time	Method
Treatment-related adverse events	After treatment one month	CTCAE or Clavien-Dindo classification

Trial Locations

Locations (1)

Tzu Chi University; 🇨🇳 Hualien City, Taiwan