Digestive Tract Cancer and CIPN

NCT ID: NCT06331962

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Digestive Tract Cancer Chemotherapy-induced Peripheral Neuropathy Remote Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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remote home-based exercise therapy group

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).

Group Type EXPERIMENTAL

remote home-based exercise therapy group

Intervention Type 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).

supervised 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 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.

Group Type ACTIVE_COMPARATOR

supervised exercise therapy group

Intervention Type 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.

regular care group

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.

Group Type OTHER

regular care group

Intervention Type 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.

Interventions

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remote 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).

Intervention Type OTHER

supervised 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.

Intervention Type OTHER

regular 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng-Feng Lin, Ph.D

Role: STUDY_CHAIR

Department of Physical Therapy, National Cheng-Kung University

Locations

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Department of Physical Therapy, National Cheng-Kung University

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng-Feng Lin, Ph.D

Role: CONTACT

886-6-2353535 ext. 5911

Facility Contacts

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Cheng-Feng Lin, Ph.D

Role: primary

Other Identifiers

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B-ER-112-010

Identifier Type: -

Identifier Source: org_study_id

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