Multiple Interactive With Nutrition and Exercise Strategies in Frailty Cancer Patients

NCT04654637 | Unknown DMC

• 1 other identifier: TCU-CHHuang
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Frailty trend

  After treatment frailty condition

  After treatment three-month

Secondary Outcomes (1)

• Treatment-related adverse events

  After treatment one month

Other Outcomes (1)

• Survival

  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.

Study Arms (4)

Arm A

EXPERIMENTAL

fix model of cycle exercise(online supervise) and routine nutrition consult

Behavioral: Nutrition and Exercise Strategies

Arm B

EXPERIMENTAL

fix model of cycle exercise(online supervise) and online nutrition consult

Behavioral: Nutrition and Exercise Strategies

Arm C

EXPERIMENTAL

individualize cycle exercise(online supervise) and routine nutrition consult

Behavioral: Nutrition and Exercise Strategies

Arm D

EXPERIMENTAL

individualize cycle exercise(online supervise) and online nutrition consult

Behavioral: Nutrition and Exercise Strategies

Interventions

Nutrition and Exercise Strategies BEHAVIORAL

Multiple Interactive with Nutrition and Exercise Strategies

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tzu Chi University: lead

Study Sites (1)

Tzu Chi University

Hualien City, 90093, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Central Study Contacts

Chu Hou Huang, PhD

CONTACT

886-3-565301; hou2017@gms.tcu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistance Professor

Model Details: Arm A: fix model of cycle exercise(online supervise) and routine nutrition consult Arm B: fix model of cycle exercise(online supervise) and online nutrition consult Arm C: individualize cycle exercise(online supervise) and routine nutrition consult Arm D: individualize cycle exercise(online supervise) and online nutrition consult

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 4, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 4, 2020

Record last verified: 2020-11

Locations

TW (1)