Explored About Temperature Packing Care to Improve the Quality of Life for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colorectal Cancer and Gastric Cancer Patient

NCT ID: NCT06205173

Last Updated: 2024-01-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2021-08-30

Brief Summary

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Investigate the effectiveness of cold and hot compress interventions in reducing peripheral neuropathy induced by Oxaliplatin chemotherapy in colorectal cancer and gastric cancer patients. The primary outcome measures include quality of life, and secondary outcome measures encompass the severity of peripheral neuropathy, manual dexterity assessed through finger strength testing, and the effects on microcirculation blood flow in the hands and feet

Detailed Description

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Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in cancer patients undergoing chemotherapy, with an overall incidence rate of approximately 70-100% for Oxaliplatin. The symptomatology typically manifests as a "glove and stocking" neuropathy, leading to sensory abnormalities that significantly impact patients' activities of daily living and reduce their overall quality of life. Furthermore, it may result in dosage reduction, treatment delays, or interruptions. Studies indicate that residual symptoms persist in 68.1% of patients one month after the completion of chemotherapy, emphasizing the long-term effects of CIPN on post-treatment individuals. Consequently, there is a pressing need for evidence-based preventive intervention research.

Conditions

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Colorectal Cancer Gastric Cancer Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

According to the traditional care model, no interventions are applied to the hands and feet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Hot compressing group

Temperature control will be maintained within the range of 37-38 degrees Celsius.The application will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection.

Group Type EXPERIMENTAL

Cold compressing

Intervention Type OTHER

The intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary.

Cold compressing group

Temperature control will be maintained within the range of 12-18 degrees Celsius.The application will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection.

Group Type EXPERIMENTAL

Hot compressing

Intervention Type OTHER

The intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary.

Interventions

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Hot compressing

The intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary.

Intervention Type OTHER

Cold compressing

The intervention in this study will commence 15 minutes before the administration of Oxaliplatin and conclude 15 minutes after the injection. Throughout the process, the patient's local site will be checked every 15 minutes for signs of redness, abnormal sensations, and skin temperature measurement to assess potential harm caused by the applied temperature. If any adverse reactions occur, the intervention will be stopped as necessary.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 20 and above, inclusive, can autonomously decide to participate in this study and complete the Participant Consent Form.
* Patients diagnosed with colorectal cancer, receiving chemotherapy for the first time, and being prescribed the standard FOLFOX regimen with Oxaliplatin as the primary agent are eligible. The dosage is 85mg/m2 administered over a 2-hour injection every 14 days, constituting one treatment cycle. A total of 6 treatment cycles will be conducted.

Exclusion Criteria

* Individuals with an undiagnosed medical condition.
* Individuals with thyroid disorders, diabetes, undergoing dialysis, pregnant, alcohol abusers, and those with immune-related diseases such as lupus erythematosus, scleroderma, dermatomyositis, and rheumatoid arthritis are excluded from the study..
* Individuals with defects in hands, feet, or fingers.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201909032RINA

Identifier Type: -

Identifier Source: org_study_id

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