CClinicalTrials.gg
Status unknownNCT05136573Updated Nov 29, 2021

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

An interventional study of Combined Exercises in Experimental Study Designs, sponsored by Chi Mei Medical Hospital. Status unknown. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-29.

Sponsored by Chi Mei Medical Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Experimental Study Designs
03

In context

Lead sponsor

Chi Mei Medical Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • bone metastasis, lower extremity lymphedema, cognitive dysfunction, musculoskeletal problems,and diabetic.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

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

    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

  • BehavioralCombined Exercises

    Combined Exercises

06

What researchers measure

Primary outcomes

  1. FACT/GOG

    FACT/GOG-CIPN

    Time frame: 12 weeks

  2. EORTC QLQ-C30

    qulity of life

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05136573
Lead sponsor
Chi Mei Medical Hospital
Responsible party
Chong-Chi Chiu (Center for quality management, Chi Mei Medical Hospital) — Principal investigator
First posted
Nov 29, 2021
Start date
Jan 1, 2022 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Nov 29, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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