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

Riphah International University

Status: Enrolling

Conditions: Chemotherapy Induced Peripheral Neuropathy; Breast Cancer Patients

Treatments: Behavioral: Conventional Exercise Therapy; Behavioral: Sensorimotor Training Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06737926

REC/RCR&AHS/24/0204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Group A: Experimental Group receiving Sensorimotor Training Exercise.

Experimental group

Description:

Participants will undergo sensorimotor training exercises targeting balance, pain reduction, and functional exercise capacity.

Treatment:

Behavioral: Sensorimotor Training Exercise

Group B: Control Group receiving Conventional Exercise Therapy.

Active Comparator group

Description:

Participants will receive conventional exercise therapy as per standard guidelines.

Treatment:

Behavioral: Conventional Exercise Therapy