Chemotherapy-induced Peripheral Neuropathy, Digestive Tract Cancer, Remote Exercise
Conditions
Brief 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.
Interventions
OTHERremote 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).
OTHERsupervised 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.
OTHERregular 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.
Sponsors
National Cheng Kung University
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire of Chemotherapy-Induced Peripheral Neuropathy | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | 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. |
| body weight | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | body weight in kg |
| body mass index | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | body mass index in kg/m2 |
| blood data | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | blood data, including blood cell count, neutrophils, lymphocytes, monocytes, hemoglobin, albumin, magnesium, mean corpuscular volume, etc. |
| Questionnaire of Quality of Life | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | 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. |
| Basic information | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | 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. |
| gene | baseline | gene |
| body height | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | body height in m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Balance | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | Use Timed Up & Go (TUG) test. Participant stands from chair upon signal, walks 3m at normal pace,returns, and sits. Time recorded |
| Sensation Test | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | Assess sensory issues from neuropathy using Romberg test |
| Cardiovascular Endurance | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | 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. |
| Muscle Strength | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention | Evaluate muscle strength using grip strength assessment device. Participant grips device withdominant hand using maximum effort. |
Countries
Taiwan
Contacts
Primary ContactCheng-Feng Lin, Ph.D
Outcome results
None listed