Digestive Tract Cancer and CIPN
- Conditions
- Remote ExerciseDigestive Tract CancerChemotherapy-induced Peripheral Neuropathy
- Registration Number
- NCT06331962
- Lead Sponsor
- National Cheng-Kung University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Age 20 and above;
- Diagnosed by a physician with gastrointestinal cancer and has undergone chemotherapy or is currently undergoing chemotherapy;
- Diagnosed by a physician with chemotherapy-induced peripheral neuropathy.
- Cognitive impairment or inability to cooperate with verbal instructions;
- Neurological, muscular, skeletal, or cardiovascular issues preventing participation in exercise training;
- Age 80 or above;
- Refusal to engage in exercise intervention or participate in data collection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method body height baseline, 4-week intervention, 8-week intervention, and 3 month after intervention body height in m
gene baseline gene
body mass index baseline, 4-week intervention, 8-week intervention, and 3 month after intervention body mass index in kg/m2
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.
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.
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.
body weight baseline, 4-week intervention, 8-week intervention, and 3 month after intervention body weight in kg
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.
- Secondary Outcome Measures
Name Time Method Sensation Test baseline, 4-week intervention, 8-week intervention, and 3 month after intervention Assess sensory issues from neuropathy using Romberg test
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.
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.
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
Trial Locations
- Locations (1)
Department of Physical Therapy, National Cheng-Kung University
🇨🇳Tainan, Taiwan
Department of Physical Therapy, National Cheng-Kung University🇨🇳Tainan, TaiwanCheng-Feng Lin, Ph.DContact