Digestive Tract Cancer and CIPN

NCT06331962 | Unknown

• 1 other identifier: B-ER-112-010
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Tract Cancer; Chemotherapy-induced Peripheral Neuropathy; Remote Exercise

Outcome Measures

Primary Outcomes (8)

• 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

• gene

  gene

  baseline

• body height

  body height in m

  baseline, 4-week intervention, 8-week intervention, and 3 month after intervention

• body weight

  body weight in kg

  baseline, 4-week intervention, 8-week intervention, and 3 month after intervention

• body mass index

  body mass index in kg/m2

  baseline, 4-week intervention, 8-week intervention, and 3 month after intervention

• 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

• 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

• 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 Outcomes (4)

• Muscle Strength

  baseline, 4-week intervention, 8-week intervention, and 3 month after intervention

• Dynamic Balance

  baseline, 4-week intervention, 8-week intervention, and 3 month after intervention

• Sensation Test

  baseline, 4-week intervention, 8-week intervention, and 3 month after intervention

• Cardiovascular Endurance

  baseline, 4-week intervention, 8-week intervention, and 3 month after intervention

Study Arms (3)

remote home-based exercise therapy group

EXPERIMENTAL

Location and Frequency: Four times per week at the individual's own home. Exercise Duration: Eight weeks (subject to adjustments based on actual progress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistance training, sensory exercises. Note: The participant will receive a customized exercise plan based on their capabilities, including guidelines and exercise instructions (exercise names, required equipment, movement sequences, repetitions, precautions).

Other: remote home-based exercise therapy group

supervised exercise therapy group

ACTIVE COMPARATOR

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 actual progress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistance training, sensory training exercises. The home-based exercise training content is partially the same as the remote home-based exercise group.

Other: supervised exercise therapy group

regular care group

OTHER

Perform regular care for eight consecutive weeks. After the tracking period ends (8 weeks), provide home-based education on resistance exercises, cardiovascular endurance exercises, and sensory training exercises.

Other: regular care group

Interventions

remote home-based exercise therapy group OTHER

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).

remote home-based exercise therapy group

supervised exercise therapy group OTHER

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.

supervised exercise therapy group

regular care group OTHER

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.

regular care group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Cheng Kung University: collaborator

Study Sites (1)

Department of Physical Therapy, National Cheng-Kung University

Tainan, 701, Taiwan

RECRUITING

Study Officials

• Cheng-Feng Lin, Ph.D

  Department of Physical Therapy, National Cheng-Kung University

  STUDY CHAIR

Central Study Contacts

Cheng-Feng Lin, Ph.D

CONTACT

886-6-2353535; connie@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: March 26, 2024
• Study Start: May 19, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 26, 2024

Record last verified: 2023-08

Locations

TW (1)