Clinical trial NCT05136573: Exercises on CIPN, Fatigue, and Quality of Life in Colon Cancer Patients Receiving Chemotherapy
Official title: Quality Association
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Experimental Study Designs
Lead sponsor: Chi Mei Medical Hospital
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: FACT/GOG
timeFrame: 12 weeks
measure: EORTC QLQ-C30
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
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Study officials:
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