Colorectal CancerNCT05882396
Rood's Approach and Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
A study testing Rood's approach and Traditional physical therapy program in people with Colorectal Cancer and Peripheral Neuropathy, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Colorectal Cancer, Peripheral Neuropathy
- What is being tested?
- Rood's approach and Traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Rood's Approach on Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
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.
Read the 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.
- Conditions
- Colorectal Cancer, Peripheral Neuropathy
- Being tested
- Rood's approach, Traditional physical therapy program
- Keywords
- Rood's approach, Oxaliplatin-induced peripheral neuropathy, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rood's approachOther
Patients will receive Rood's approach includes various facilitatory and inhibitory techniques.
Traditional physical therapy programOther
Participants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rood's approach group | Active comparator | Thirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy. Receives: 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. Receives: Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at twelve weeks after the intervention
Secondary outcomes (1)
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
Measured: Change from baseline at twelve weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion28 Dec 2023 (estimated)
- Study completion11 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy. will be indiscriminately assigned to two groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa MA El Sayeh, PhD, Principal investigator, Lecturer at Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882396
- Sponsor's protocol ID
- P.T.REC/012/004322
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rood's Approach on Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT05882396
- Acronym / sponsor ID
- P.T.REC/012/004322
- Conditions
- Colorectal Cancer, Peripheral Neuropathy
- Keywords
- Rood's approach, Oxaliplatin-induced peripheral neuropathy, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 28 Dec 2023 (estimated)
- Study completion
- 11 Jan 2024 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty Patients with colorectal cancer have oxaliplatin-induced peripheral neuropathy. will be indiscriminately assigned to two groups.
| Arm | Type | Receives |
|---|---|---|
| Rood's approach group | Active comparator | Other: Rood's approach, Other: Traditional physical therapy programThirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy. |
| Traditional physical therapy program group | Active comparator | Other: Traditional physical therapy programThirty colorectal cancer patients have oxaliplatin-induced peripheral neuropathy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rood's approachPatients will receive Rood's approach includes various facilitatory and inhibitory techniques. | Other | Rood's approach group |
| Traditional physical therapy programParticipants will be engaged in aerobic exercises and balance training, three times per week for twelve weeks. | Other | Rood's approach group, Traditional physical therapy program group |
Primary outcome
NCT-CTCAE peripheral neuropathy grading
Time frame: Change from baseline at twelve weeks after the intervention
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
Time frame: Change from baseline at twelve weeks after the intervention
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
Time frame: Change from baseline at twelve weeks after the intervention
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
Time frame: Change from baseline at twelve weeks after the intervention
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.
1 secondary outcome
The 4-Stage Balance Test
Time frame: Change from baseline at twelve weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa MA El Sayeh, PhD principal investigator
Lecturer at Faculty of Physical Therapy, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Rood's approach and Traditional physical therapy program in people with Colorectal Cancer and Peripheral Neuropathy, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa MA El Sayeh, PhD (+201007766160, sh.sayeh87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCT-CTCAE peripheral neuropathy grading (time frame: Change from baseline at twelve weeks after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.