Chemotherapy Induced Peripheral Neuropathy, Breast Cancer Patients
Conditions
Keywords
Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy, Postural Balance, Sensorimotor Neuropathy, Exercise
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.
Interventions
BEHAVIORALSensorimotor Training Exercise
Participants 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.
BEHAVIORALConventional Exercise Therapy
Participants 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.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Pakistan
Contacts
Primary ContactImran Amjad, PHD
Outcome results
None listed