Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients

Not Applicable

Recruiting

Conditions: Chemotherapy Induced Peripheral Neuropathy
Breast Cancer Patients

Brief Summary: 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.

Detailed Description: The study incorporated a single blinded randomized controlled trial conducted at Mayo Hospital, Lahore. It involved 22 participants (N=22) recruited by using non-probability convenience sampling technique according to inclusion criteria and randomly allocated into either of two groups (Experimental group or Control group) using randomizer.org. The participants in experimental group performed sensorimotor training based on progressively challenging balance exercises on unstable surfaces. Participants performed three sets of exercises per session twice a week for 6 weeks, 45 minutes per session. The control group performed conventional exercises such as range of motion, stretching, strengthening, deep breathing and aerobic exercises for 2 times a week for 6 weeks, 45 minutes per session. Pre and post assessment of participants was done on numeric pain rating scale for pain intensity, TUG test for balance, activities-specific balance confidence scale for perceived balance confidence, 6-minute walk test for functional exercise capacity and EORTC QLQ C-30 for quality of life.

Recruitment & Eligibility

Inclusion Criteria

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
CIPN symptoms as subjectively assessed by FACT/GOG-Ntx. Score ranges from 0-44 (5). 0 - 10: Minimal or no neurotoxicity symptoms, 11 - 20: Mild neurotoxicity symptoms, 21 - 30: Moderate neurotoxicity symptoms, 31 - 40: Severe neurotoxicity symptoms, 41 - 44: Very severe neurotoxicity symptoms
For balance testing Fullerton Advanced Balance (FAB) scale was used. 0-19 = high risk of falls, 20-29 = moderate balance impairment, 30-40 = good balance. The cut off value is ≤ 25/40 Points.
Objective neurological testing such as Achilles and patellar tendon reflexes (1 = agile, 2 = weak, 3 = missing), peripheral deep sensitivity (0=no sensitivity to 8=highest sensitivity), light touch perception (symmetrical or impaired), sense of position (1 = position recognized, 2 = only position of knee recognized, and 3 = no recognition) and lower leg strength (0 = no activity to 5 = normal force) rated on a Likert-scale

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	6 weeks	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.
TUG Test	6 weeks	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
Activities-Specific Balance Confidence Scale	6 weeks	The ABC-Scale is a self-reported assessment of the participant's level of confidence in static and dynamic balance while doing functional activities
6-Minute Walk Test	6 weeks	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

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale	6 weeks	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
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)	6 weeks	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).
Fullerton Advanced Balance Scale (FAB Scale)	6 weeks	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.

Locations (2): Mayo Hospital Lahore
🇵🇰
Lahore, Punjab, Pakistan
Mayo Hospital
🇵🇰
Lahore, Punjab, Pakistan