Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorRiphah International University
About this trial
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Therefore, the objective of this study is to determine the effects of Sensorimotor training on pain intensity, perceived balance confidence, and functional exercise capacity with chemotherapy-induced peripheral neuropathy in breast cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females with invasive ductal carcinoma, stages I-III
Age ranged between 30-65 years
3-6 months post breast cancer diagnosis
Those who have completed chemotherapy treatment and are medically stable
Disqualifiers
Women with additional types of cancer besides breast cancer
Chronic medical conditions such as poorly controlled diabetes (6)
Significant neurological (multiple sclerosis) or cardiopulmonary disease (myocardial infarction < 3 months) that may affect performance (6)
Unstable bone metastasis
Trial design
Design model
Parallel
Treatments tested in this trial
Sensorimotor Training Exercise
BehavioralParticipants will perform sensorimotor training exercises designed to improve balance, reduce pain intensity, and enhance functional exercise capacity. The program will include progressive exercises focusing on proprioception, neuromuscular coordination, and functional mobility. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist.
Conventional Exercise Therapy
BehavioralParticipants will undergo conventional exercise therapy, including stretching, strengthening, and aerobic exercises, based on standard physiotherapy protocols. The therapy aims to maintain joint mobility, reduce stiffness, and improve general physical fitness. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Group A: Experimental Group receiving Sensorimotor Training Exercise.Experimental treatment 1 intervention
Group B: Group B: Control Group receiving Conventional Exercise Therapy.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Pain Rating Scale (NPRS)
It is a uni-dimensional subjective measure of pain intensity in adults, including those with cancer pain. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
Time frame
6 weeks2
TUG Test
It is used to determine the fall risk and measure the progress of balance. Mobility and balance is assessed based on time to complete the test: \< 10 seconds = normal. \< 20 seconds = good mobility \< 30 seconds = walking and balance problems
Time frame
6 weeks3
Activities-Specific Balance Confidence Scale
The ABC-Scale is a self-reported assessment of the participant's level of confidence in static and dynamic balance while doing functional activities
Time frame
6 weeks4
6-Minute Walk Test
The 6-minute walk test (6MWT) is a standardized field test used to predict cardio-respiratory fitness in healthy individuals, as well as to assess functional exercise capacity and responsiveness to rehabilitation treatments in a variety of patient groups
Time frame
6 weeksSecondary outcomes
1
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale
The FACT/GOG Ntx subscale is designed to measure chemotherapy-induced PN. It contains 11 items covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy
Time frame
6 weeks2
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 is composed of nine multi-item scales: 5 functioning scales (physical, role, cognitive, emotional and social), a global QOL scale, and 3 symptom scales (fatigue, pain and nausea/vomiting).
Time frame
6 weeks3
Fullerton Advanced Balance Scale (FAB Scale)
It is a screening tool which can be used in different group. It has long form (consisting of 10 tasks) and a short form (consisting of 4 tasks). The scale consists of a 5-point Likert scale from 0-4.
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov