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Trial Title:
Digestive Tract Cancer and CIPN
NCT ID:
NCT06331962
Condition:
Digestive Tract Cancer
Chemotherapy-induced Peripheral Neuropathy
Remote Exercise
Conditions: Official terms:
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
remote home-based exercise therapy group
Description:
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).
Arm group label:
remote home-based exercise therapy group
Intervention type:
Other
Intervention name:
supervised exercise therapy group
Description:
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.
Arm group label:
supervised exercise therapy group
Intervention type:
Other
Intervention name:
regular care group
Description:
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.
Arm group label:
regular care group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Physical Therapy, National Cheng-Kung University
Address:
City:
Tainan
Zip:
701
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Cheng-Feng Lin, Ph.D
Start date:
May 19, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
National Cheng-Kung University Hospital
Agency class:
Other
Collaborator:
Agency:
National Cheng Kung University
Agency class:
Other
Source:
National Cheng-Kung University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331962
