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

NCT05882396 | Unknown

• 1 other identifier: P.T.REC/012/004322
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer; Peripheral Neuropathy

Keywords

Rood's approach; Oxaliplatin-induced peripheral neuropathy; Colorectal cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  Change from baseline at twelve weeks after the intervention

• 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.

  Change from baseline at twelve weeks after the intervention

• 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.

  Change from baseline at twelve weeks after the intervention

• 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.

  Change from baseline at twelve weeks after the intervention

Secondary Outcomes (1)

• The 4-Stage Balance Test

  Change from baseline at twelve weeks after the intervention

Study Arms (2)

Rood's approach group

ACTIVE COMPARATOR

Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

Other: Rood's approach; Other: Traditional physical therapy program

Traditional physical therapy program group

ACTIVE COMPARATOR

Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy.

Other: Traditional physical therapy program

Interventions

Rood's approach OTHER

Patients will receive Rood's approach includes various facilitatory and inhibitory techniques.

Rood's approach group

Traditional physical therapy program OTHER

Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.

Rood's approach group; Traditional physical therapy program group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Peripheral Nervous System Diseases

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; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Shaimaa MA El Sayeh, PhD

  Lecturer at Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaimaa MA El Sayeh, PhD

CONTACT

+201007766160; sh.sayeh87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Model Details: Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy. will be indiscriminately assigned to two groups.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: December 28, 2023
• Study Completion: January 11, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share