Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sensorimotor Training Exercise, Conventional Exercise Therapy.
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Peripheral Neuropathy, Breast Cancer Patients. Basic parameters: 30 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Sensorimotor Training on Pain Intensity, Perceived Balance Confidence and Functional Exercise Capacity With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
Overview
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
- Behavioral Sensorimotor 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. - Behavioral Conventional 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.
Primary outcome measures
- Numeric Pain Rating Scale (NPRS) [Time frame: 6 weeks]
- TUG Test [Time frame: 6 weeks]
- Activities-Specific Balance Confidence Scale [Time frame: 6 weeks]
- 6-Minute Walk Test [Time frame: 6 weeks]
Secondary outcome measures (3)
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale [Time frame: 6 weeks]
- EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) [Time frame: 6 weeks]
- Fullerton Advanced Balance Scale (FAB Scale) [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 2 centers
- Mayo Hospital Lahore — Lahore
- Mayo Hospital — Lahore
Identifiers
NCT: NCT06737926 · REC/RCR&AHS/24/0204