Clinical trial NCT06331962: Digestive Tract Cancer and CIPN
Official title: The Effects of Remote Exercise Program in Patients With Digestive Tract Cancer and Chemotherapy-induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digestive Tract Cancer
Chemotherapy-induced Peripheral Neuropathy
Remote Exercise
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: National Cheng Kung University
First posted: 2024-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Basic information
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: gene
timeFrame: baseline
measure: body height
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: body weight
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: body mass index
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: blood data
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: Questionnaire of Quality of Life
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: Questionnaire of Chemotherapy-Induced Peripheral Neuropathy
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Secondary outcomes:
measure: Muscle Strength
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: Dynamic Balance
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: Sensation Test
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
measure: Cardiovascular Endurance
timeFrame: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Physical Therapy, National Cheng-Kung University
Study officials:
affiliation: Department of Physical Therapy, National Cheng-Kung University
name: Cheng-Feng Lin, Ph.D
role: STUDY_CHAIR
References: