Digestive Tract Cancer and CIPN

National Cheng-Kung University

Status: Enrolling

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

Treatments: Other: remote home-based exercise therapy group; Other: regular care group; Other: supervised exercise therapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT06331962

B-ER-112-010

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

remote home-based exercise therapy group

Experimental group

Description:

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).

Treatment:

Other: remote home-based exercise therapy group

supervised exercise therapy group

Active Comparator 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 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.

Treatment:

Other: supervised exercise therapy group

regular care group

Other group

Description:

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.

Treatment:

Other: regular care group