Protocol summary
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Study aim
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Investigating the added value of sensory retraining to duloxetine on pain, sensory symptoms, nerve conduction velocity, hand dexterity and static balance in patients with chemotherapy induced sensory peripheral neuropathy
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Design
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A controlled, double group, single blinded (assessor), randomized, phase 3 clinical trial on 34 patients. For randomization permutational randomization method with the number of blocks 17 and block size 2 is used
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Settings and conduct
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patients who have been diagnosed with colon cancer and have undergone chemotherapy with oxaliplatin in the oncology departments of Shiraz University of Medical Sciences will enter. one group will receive sensory retraining exercises and duloxetine, and another group will receive only duloxetine. The assessor and the therapist are not the same person, and in this way the assessor will be blinded
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age over 40 years
presence of symptoms of peripheral neuropathy
A score of at least 4 out of 10 in at least one of the symptoms of neuropathy on the numeric rating scale of pain in the hands and feet in the last week
Completion of the chemotherapy course of patients at least 3 months and at most 9 months before the start of the study
life expectancy for 6 months
Exclusion criteria:
The presence of other types of peripheral neuropathy before the start of chemotherapy
epilepsy, arrhythmia or pacemaker
wound or swelling in the treatment area
diabetes, hyperthyroidism, kidney failure, hepatitis, AIDS and vitamin B12 deficiency
pregnancy
Use of drugs such as Gabapentin and Pregabalin by patients during the study period
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Intervention groups
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In the first group, participants receive sensory retraining exercises and duloxetine, and in the second group, participants receive only duloxetine
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Main outcome variables
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VAS
NCV
Hand dexterity
Static balance
Quality of life
Lower limb function
General information
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Reason for update
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Acronym
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CIPN
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IRCT registration information
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IRCT registration number:
IRCT20160221026674N5
Registration date:
2024-07-26, 1403/05/05
Registration timing:
prospective
Last update:
2025-04-19, 1404/01/30
Update count:
1
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Registration date
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2024-07-26, 1403/05/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-09-20, 1403/06/30
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Expected recruitment end date
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2025-01-19, 1403/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the added value of sensory retraining to duloxetine on pain, sensory symptoms, nerve conduction velocity, hand dexterity and static balance in patients with chemotherapy-induced sensory peripheral neuropathy- a controlled clinical trial study
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Public title
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The effect of sensory retraining on the symptoms of patients with chemotherapy-induced sensory peripheral neuropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 40 years
Reporting the presence of symptoms of peripheral neuropathy including pain, numbness, tingling and any abnormal sensations by the patient
A score of at least 4 out of 10 in at least one of the symptoms of neuropathy in the numeric rating scale of pain in the hands and feet in the last week
Completion of the chemotherapy course of patients at least 3 months and at most 9 months before the start of the study and the existence of life expectancy for at least 6 months
Exclusion criteria:
The presence of other types of peripheral neuropathy before the start of chemotherapy
The presence of any wound or swelling in the treatment area (hands and feet)
Epilepsy or cardiac arrhythmia or the presence of a pacemaker in the patient's heart
Suffering from diabetes, hyperthyroidism, kidney failure, hepatitis, AIDS and vitamin B12 deficiency
pregnancy
Use of drugs such as Gabapentin and Pregabalin by patients during the study period
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Age
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From 40 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Based on permutation randomization method with the number of blocks 17 and block size 2, the participants are placed in two groups of 17 people of sensory retraining exercises and duloxetine, and duloxetine alone. Randomization will be done manually by an epidemiologist who is unaware of the study groups. Random assignment of samples to groups is done with the ratio of 1:1 and with the help of numbered envelopes. Before performing the initial evaluation of each of the samples, the corresponding envelope is returned by the therapist at the Faculty of Rehabilitation Sciences in Shiraz.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assessor does not know which of the two groups each participant is placed in.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-06-12, 1403/03/23
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Ethics committee reference number
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IR.SUMS.REHAB.REC.1403.006
Health conditions studied
1
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Description of health condition studied
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Colon Cancer
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ICD-10 code
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C18
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ICD-10 code description
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Malignant neoplasm of colon
Primary outcomes
1
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Description
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Pain or paresthesia intensity
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Timepoint
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Before the start of the intervention and 28 days and 56 days after the start of the intervention
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Method of measurement
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VAS
Secondary outcomes
1
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Description
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Ulnar, median and med. & lat. plantar NCV
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Timepoint
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Before the start of the intervention and 28 days and 56 days after the start of the intervention
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Method of measurement
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Electromyography device
2
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Description
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Hand dexterity
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Timepoint
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before the start of the intervention and 28 days and 56 days after the start of the intervention
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Method of measurement
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Purdue peg board
3
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Description
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Static balance
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Timepoint
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before the start of the intervention and 28 days and 56 days after the start of the intervention
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Method of measurement
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Chronometer
4
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Description
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Quality of life
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Timepoint
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Before the start of the intervention and 28 days and 56 days after the start of the intervention
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Method of measurement
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EORTC QLQ_30 questionnare
5
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Description
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Lower limb function
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Timepoint
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Before the start of the intervention and 28 days and 56 days after the start of the intervention
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Method of measurement
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TUG test time using chronometer
Intervention groups
1
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Description
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Intervention group: Sensory retraining exercises and duloxetine drug
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Category
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Treatment - Other
2
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Description
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Control group: Duloxetine drug
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Information collection form including primary and secondary outcomes, informed consent form and SPSS file
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When the data will become available and for how long
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After publication the results of the study
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Only for recording information in scientific databases
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From where data/document is obtainable
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Correspondence with the project manager by email.
mohamadm@sums.ac.ir
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What processes are involved for a request to access data/document
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Maximum one month after sending the request by email
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Comments
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