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

Phase

N/A

Condition

Neurologic Disorders

Treatment

Sensorimotor Training Exercise

Conventional Exercise Therapy

Clinical Study ID

NCT06737926

REC/RCR&AHS/24/0204

Ages 30-65
Female

Study 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.

Eligibility Criteria

Inclusion

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 = highrisk of falls, 20-29 = moderate balance impairment, 30-40 = good balance. The cutoff 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 ofposition (1 = position recognized, 2 = only position of knee recognized, and 3 = norecognition) and lower leg strength (0 = no activity to 5 = normal force) rated on aLikert-scale

Exclusion

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 (myocardialinfarction < 3 months) that may affect performance (6)
Unstable bone metastasis

Study Design

Sensorimotor Training Exercise

January 15, 2024

December 31, 2024

Study 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.

Connect with a study center

Mayo Hospital
Lahore, Punjab 54000
Pakistan
Active - Recruiting
Mayo Hospital Lahore
Lahore, Punjab 54000
Pakistan
Active - Recruiting

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