Digestive Tract Cancer and CIPN

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

The Effects of Remote Exercise Program in Patients With Digestive Tract Cancer and Chemotherapy-induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331962
• Other study ID #: B-ER-112-010
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2023
• Source: National Cheng-Kung University Hospital
• Contact: Cheng-Feng Lin, Ph.D
• Phone: 886-6-2353535
• Email: connie[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 20 and above;

2. Diagnosed by a physician with gastrointestinal cancer and has undergone chemotherapy or is currently undergoing chemotherapy;

3. Diagnosed by a physician with chemotherapy-induced peripheral neuropathy.

Exclusion Criteria:

1. Cognitive impairment or inability to cooperate with verbal instructions;

2. Neurological, muscular, skeletal, or cardiovascular issues preventing participation in exercise training;

3. Age 80 or above;

4. Refusal to engage in exercise intervention or participate in data collection.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• remote home-based exercise therapy group
Location and Frequency: Four times per week at the individual's ownhome. Exercise Duration: Eight weeks (subject to adjustments based onactual progress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistancetraining, sensory exercises. Note: The participant will receive a customized exercise plan based ontheir capabilities, including guidelines and exercise instructions (exercisenames, required equipment, movement sequences, repetitions,precautions).
• supervised exercise therapy group
Exercise Location and Frequency: Physiotherapy Center (twice a week)and individual's home (twice a week). Exercise Duration: Eight weeks (subject to adjustments based on actualprogress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistancetraining, sensory training exercises. The home-based exercise trainingcontent is partially the same as the remote home-based exercise group.
• regular care group
Perform regular care for eight consecutive weeks. After the trackingperiod ends (8 weeks), provide home-based education on resistanceexercises, cardiovascular endurance exercises, and sensory trainingexercises.

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy, National Cheng-Kung University	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basic information	Gender, date of birth, education level, survival days and status, exercise habit, alcohol consume history, smoking history, type of cancer, stage of cancer, start date of chemotherapy, number of chemotherapy sessions prior to intervention, chemotherapy drugs used, study period, and the subjects' medical history.	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Primary	gene	gene	baseline
Primary	body height	body height in m	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Primary	body weight	body weight in kg	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Primary	body mass index	body mass index in kg/m2	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Primary	blood data	blood data, including blood cell count, neutrophils, lymphocytes, monocytes, hemoglobin, albumin, magnesium, mean corpuscular volume, etc.	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Primary	Questionnaire of Quality of Life	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) is to assess the quality of life. The transferred score range for this tool is typically from 0 to 100, where 0 indicates very poor quality of life, and 100 indicates very good quality of life. There are five aspects in the QLQ-C30, including physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. In this scoring system, higher scores generally indicate better quality of life, while lower scores suggest poorer quality of life.	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Primary	Questionnaire of Chemotherapy-Induced Peripheral Neuropathy	The European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20-item scale (CIPN-20) assesses sensory abnormalities in patients. Scores range from 0 to 80, with 0 indicating no abnormalities and 80 severe abnormalities. Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The total score is calculated by adding scores from items 1 to 19, ranging from 19 to 76, termed the CIPN20 sum1-19 score. Item 20 evaluates male impotence, relevant only for males. Additionally, items are categorized into sensory (1, 2, 3, 4, 5, 6, 9, 10, and 18), motor (7, 8, 11, 12, 13, 14, 15, and 19), and autonomic (16, 17, and 20) subscales.	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Secondary	Muscle Strength	Evaluate muscle strength using grip strength assessment device. Participant grips device withdominant hand using maximum effort.	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Secondary	Dynamic Balance	Use Timed Up & Go (TUG) test. Participant stands from chair upon signal, walks 3m at normal pace,returns, and sits. Time recorded	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Secondary	Sensation Test	Assess sensory issues from neuropathy using Romberg test	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Secondary	Cardiovascular Endurance	Assess using 2-min step test. Participant steps in place for 2 mins, feet higher thanmidpoint between patella and iliac spine. Tester notes successful steps in 2 mins.	baseline, 4-week intervention, 8-week intervention, and 3 month after intervention