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Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients

Primary Purpose

Colorectal Cancer, Peripheral Neuropathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rood's approach
Traditional physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Rood's approach, Oxaliplatin-induced peripheral neuropathy, Colorectal cancer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient can participate in the study if they had at least one cycle of oxaliplatin chemotherapy. Colorectal cancer patients who have oxaliplatin-induced peripheral neuropathy, the patients included in the study with mild to moderate neuropathy according to mTNS. Patients from both genders. Their ages range from 18 to 60 years old. Exclusion Criteria: Patients who had a history of any other neuropathy as diabetic neuropathy. Patients with an unstable medical condition during chemotherapy. Patients who are starting new therapy or dose modification during the study period. Patients with morbid obesity "body mass index >40%". Patients with a history of non-surgically repaired nerve compression injuries such as carpal tunnel, brachial plexopathy, spinal stenosis, and spinal nerve root compression. Patients with a history of central nervous system primary or metastatic malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Rood's approach group

    Traditional physical therapy program group

    Arm Description

    Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

    Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

    Outcomes

    Primary Outcome Measures

    NCT-CTCAE peripheral neuropathy grading
    It consists of of 5 grades; Grade (1) is asymptomatic may be accompanied by loss of tendon reflex or paraesthesia. Grade (2) is moderate symptoms which limit instrumental activities of daily life Grade (3) is severe symptoms which limit self-care activates of daily life. Grade (4) is life threatening consequences or urgent intervention indicated. Grade (5) is death.
    The Ntx-12 questionnaire
    It is comprised of 12 statements intended to measure the severity and impact of peripheral sensory neuropathy on patients' lives. Patients were instructed to complete the Arabic version of the Ntx-12 and choose the number corresponding to how true each statement was for them using a Likert-type scale, with 0 indicating not at all; 1, a little bit; 2, somewhat; 3, quite a bit; and 4, very much.
    Brief Pain Inventory Short Form (BPI-SF) Bworst pain
    The BPI-SF assesses pain at its worst, least, average, and now (current pain). Patients respond on 0-to-10 numerical rating scales. Each scale presented as a row of equidistant numbers, where 0 = no pain^ and 10 = pain as bad as you can imagine.
    Total Neuropathy Score
    used to measure these constructs. It includes 6 items graded from 0 to 4 according to the patients' symptoms, the total grade from 0 to 24. The higher grade the worse neuropathy. It graded as mild (1:9), moderate (10:19) and (20:24) severe.

    Secondary Outcome Measures

    The 4-Stage Balance Test
    is a recommended measure from the Centers for Disease Control and Prevention STEADI (Stopping Elderly Accidents, Deaths, and Injuries) falls campaign to recognize fall risk. An adult who cannot hold tandem stance for 10 seconds is at a higher risk for falls. [18] Patient A was able to stand in tandem stance for 2 seconds on each side. Patient B was able to stand on single leg stance for 10 seconds on each side

    Full Information

    First Posted
    May 19, 2023
    Last Updated
    May 26, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05882396
    Brief Title
    Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
    Official Title
    Efficacy of Rood's Approach on Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 28, 2023 (Anticipated)
    Study Completion Date
    January 11, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Oxaliplatin-induced chronic peripheral neuropathy is of major concern to oncologists and patients as it has been shown to affect patients' health-related quality of life. Although a number of interventions have been implicated, none of them can be recommended for clinical use. This therapeutic failure reflects a poor understanding of the real mechanism of oxaliplatin-induced neuropathy. However, oxidative stress is identified to be one of the main biomolecular dysfunctions in this neuropathy. Rood's approach is a neurophysiological approach that is based on reflexes of the central nervous system in which the sensory stimulation provides desired muscular response and was specially designed for patients with motor control problems. It was developed by Margeret Rood in 1940. According to Rood, sensory stimulation can activate or deactivate the receptor by facilitation or inhibition, which makes it possible to get the desired muscular response.
    Detailed Description
    So, the purpose of the study is to investigate the efficiency of Rood's approach on oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Peripheral Neuropathy
    Keywords
    Rood's approach, Oxaliplatin-induced peripheral neuropathy, Colorectal cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy. will be indiscriminately assigned to two groups.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rood's approach group
    Arm Type
    Active Comparator
    Arm Description
    Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.
    Arm Title
    Traditional physical therapy program group
    Arm Type
    Active Comparator
    Arm Description
    Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.
    Intervention Type
    Other
    Intervention Name(s)
    Rood's approach
    Intervention Description
    Patients will receive Rood's approach includes various facilitatory and inhibitory techniques.
    Intervention Type
    Other
    Intervention Name(s)
    Traditional physical therapy program
    Intervention Description
    Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.
    Primary Outcome Measure Information:
    Title
    NCT-CTCAE peripheral neuropathy grading
    Description
    It consists of of 5 grades; Grade (1) is asymptomatic may be accompanied by loss of tendon reflex or paraesthesia. Grade (2) is moderate symptoms which limit instrumental activities of daily life Grade (3) is severe symptoms which limit self-care activates of daily life. Grade (4) is life threatening consequences or urgent intervention indicated. Grade (5) is death.
    Time Frame
    Change from baseline at twelve weeks after the intervention
    Title
    The Ntx-12 questionnaire
    Description
    It is comprised of 12 statements intended to measure the severity and impact of peripheral sensory neuropathy on patients' lives. Patients were instructed to complete the Arabic version of the Ntx-12 and choose the number corresponding to how true each statement was for them using a Likert-type scale, with 0 indicating not at all; 1, a little bit; 2, somewhat; 3, quite a bit; and 4, very much.
    Time Frame
    Change from baseline at twelve weeks after the intervention
    Title
    Brief Pain Inventory Short Form (BPI-SF) Bworst pain
    Description
    The BPI-SF assesses pain at its worst, least, average, and now (current pain). Patients respond on 0-to-10 numerical rating scales. Each scale presented as a row of equidistant numbers, where 0 = no pain^ and 10 = pain as bad as you can imagine.
    Time Frame
    Change from baseline at twelve weeks after the intervention
    Title
    Total Neuropathy Score
    Description
    used to measure these constructs. It includes 6 items graded from 0 to 4 according to the patients' symptoms, the total grade from 0 to 24. The higher grade the worse neuropathy. It graded as mild (1:9), moderate (10:19) and (20:24) severe.
    Time Frame
    Change from baseline at twelve weeks after the intervention
    Secondary Outcome Measure Information:
    Title
    The 4-Stage Balance Test
    Description
    is a recommended measure from the Centers for Disease Control and Prevention STEADI (Stopping Elderly Accidents, Deaths, and Injuries) falls campaign to recognize fall risk. An adult who cannot hold tandem stance for 10 seconds is at a higher risk for falls. [18] Patient A was able to stand in tandem stance for 2 seconds on each side. Patient B was able to stand on single leg stance for 10 seconds on each side
    Time Frame
    Change from baseline at twelve weeks after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient can participate in the study if they had at least one cycle of oxaliplatin chemotherapy. Colorectal cancer patients who have oxaliplatin-induced peripheral neuropathy, the patients included in the study with mild to moderate neuropathy according to mTNS. Patients from both genders. Their ages range from 18 to 60 years old. Exclusion Criteria: Patients who had a history of any other neuropathy as diabetic neuropathy. Patients with an unstable medical condition during chemotherapy. Patients who are starting new therapy or dose modification during the study period. Patients with morbid obesity "body mass index >40%". Patients with a history of non-surgically repaired nerve compression injuries such as carpal tunnel, brachial plexopathy, spinal stenosis, and spinal nerve root compression. Patients with a history of central nervous system primary or metastatic malignancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shaimaa MA El Sayeh, PhD
    Phone
    +201007766160
    Email
    sh.sayeh87@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shaimaa MA El Sayeh, PhD
    Organizational Affiliation
    Lecturer at Faculty of Physical Therapy, Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients

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