Multiple Interactive With Nutrition and Exercise Strategies in Frailty Cancer Patients

December 3, 2020 updated by: Chun Hou Huang, Tzu Chi University

Department of Nursing, Tzu Chi University, Hualien, Taiwan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Hualien City, Taiwan, 90093
        • Recruiting
        • Tzu Chi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
fix model of cycle exercise(online supervise) and routine nutrition consult
Behavioral: Nutrition and Exercise Strategies
Multiple Interactive with Nutrition and Exercise Strategies
Experimental: Arm B
fix model of cycle exercise(online supervise) and online nutrition consult
Behavioral: Nutrition and Exercise Strategies
Multiple Interactive with Nutrition and Exercise Strategies
Experimental: Arm C
individualize cycle exercise(online supervise) and routine nutrition consult
Behavioral: Nutrition and Exercise Strategies
Multiple Interactive with Nutrition and Exercise Strategies
Experimental: Arm D
individualize cycle exercise(online supervise) and online nutrition consult
Behavioral: Nutrition and Exercise Strategies
Multiple Interactive with Nutrition and Exercise Strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty trend
Time Frame: After treatment three-month
After treatment frailty condition
After treatment three-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events
Time Frame: After treatment one month
CTCAE or Clavien-Dindo classification
After treatment one month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tzu Chi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TCU-CHHuang

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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