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

NCT06205173 | Completed

• 1 other identifier: 201909032RINA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer; Gastric Cancer; Chemotherapy-induced Peripheral Neuropathy

Keywords

Hot compressing; Colon Cancer; Colorectal Cancer; Chemotherapy-induced Peripheral Neuropathy; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life

  Quality of Life was measured by EORTC-QLQ-C30.The scale assesses symptoms, functionality, and overall health status/life quality. Each item is transformed to a 0-100 scale according to a standardized scoring procedure.Higher scores indicate more severe symptoms, while in the functionality and overall health status/life quality sections, higher scores signify better conditions.

  (1) Before the initiation of the first chemotherapy session. (2) Before the 6th administration of chemotherapy drugs. (3) Before the 12th administration of chemotherapy drugs. (4) Within three months after the completion of the chemotherapy course.

Secondary Outcomes (4)

• The effectiveness of Cold and Hot Compress Nursing Interventions on the Quality of Life and severity of Peripheral Neuropathy.

  (1) Before the initiation of the first chemotherapy session. (2) Before each administration of chemotherapy drugs (total of 12 times). (3) Within three months after the completion of the chemotherapy course.

• The effectiveness of Cold and Hot Compress Nursing Interventions on the Severity of Peripheral Neuropathy.

  (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course

• The effectiveness of Cold and Hot Compress Nursing Interventions on the Symptoms of Peripheral Neuropathy.

  (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course

• The Effectiveness of Cold and Hot Compress Nursing Interventions on the Neurological Changes in the Hands and Feet.

  (1) before the initiation of Oxaliplatin treatment, (2)after the completion of the 6th injection until the start of the 7th injection (approximately three months into chemotherapy), (3)Within three months after the completion of the chemotherapy course

Study Arms (3)

Control group

NO INTERVENTION

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

Hot compressing group

EXPERIMENTAL

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.

Other: Cold compressing

Cold compressing group

EXPERIMENTAL

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.

Other: Hot compressing

Interventions

Hot compressing 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

Cold compressing 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.

Hot compressing group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 802, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: January 12, 2024
• Study Start: August 19, 2020
• Primary Completion: August 9, 2021
• Study Completion: August 30, 2021
• Last Updated: January 12, 2024

Record last verified: 2023-11

Locations

TW (1)