Exercises on CIPN, Fatigue, and Quality of Life in Colon Cancer Patients Receiving Chemotherapy

NCT05136573 | Unknown

• 1 other identifier: Chi Mei
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: Cancer is one of the biggest global health threats. The incidence and mortality of colorectal cancer (CRC) are increasing. The treatment of CRC is mainly surgical resection, and the standard treatment of metastatic colorectal cancer is Oxaliplatin chemotherapy, which is mainly a platinum agent (Alkylating agent). Oxaliplatin can exert its anti-cancer therapeutic effect by binding to cell DNA, and become toxic to neurons, damaging large and small fibers outside the brain and spinal cord. Causes peripheral neuropathy, which seriously affects the quality of life of patients. The purpose to develop the interventional and investigate intervention by exercise program of CRC patients with regard to the improvement effect of peripheral neuropathy, fatigue and quality of life during the treatment. Methods: Experimental study designs were used, and samples were taken from a regional teaching hospital. The control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises, balance training and resistance exercises twice a week, 60 minutes each time, plus weekly 5 walking exercises, 30 minutes each time, for a total of 12 weeks, of which the exercise training during chemotherapy and hospitalization is performed under the supervision of the investigator, and 1 balance training and resistance exercise are performed for 60 minutes each time to ensure that the patient performs. The correctness and safety of exercises, and balance training and resistance exercises in combination with the home style. During the home exercises, the researchers will give weekly telephone interviews to understand the patient's exercise status, and indeed achieve the balance training and resistance exercises twice a week. All measurement tools and methods are implemented in accordance with consistent standard operations. The control group took pre-tests when the case was closed, without interventional measures, but also performed post-tests in the same way as the experimental group at 6 weeks, 8 weeks, 10 weeks, and 12 weeks in the interventional experimental group.

Conditions

Experimental Study Designs

Outcome Measures

Primary Outcomes (2)

• FACT/GOG

  FACT/GOG-CIPN

  12 weeks

• EORTC QLQ-C30

  qulity of life

  12 weeks

Study Arms (1)

Combined Exercises on Symptoms of CIPN, Fatigue, and Quality of Life in Colon Cancer Patients

EXPERIMENTAL

The control group received routine care and maintenance of general daily activities; the experimental group received routine care and maintenance of general daily activities, and also received combined exercises

Behavioral: Combined Exercises

Interventions

Combined Exercises BEHAVIORAL

Combined Exercises

Combined Exercises on Symptoms of CIPN, Fatigue, and Quality of Life in Colon Cancer Patients

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with colon cancer, were getting chemotherapeutic drugs with oxaliplatin.

You may not qualify if:

• bone metastasis, lower extremity lymphedema, cognitive dysfunction, musculoskeletal problems,and diabetic.

Sponsors & Collaborators

• Chi Mei Medical Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for quality management

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 29, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: November 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share