Clinical trial NCT06737926: Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy Induced Peripheral Neuropathy
Breast Cancer Patients
Keywords: Breast Cancer
Chemotherapy-Induced Peripheral Neuropathy
Postural Balance
Sensorimotor Neuropathy
Exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6 weeks
measure: TUG Test
timeFrame: 6 weeks
measure: Activities-Specific Balance Confidence Scale
timeFrame: 6 weeks
measure: 6-Minute Walk Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale
timeFrame: 6 weeks
measure: EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: 6 weeks
measure: Fullerton Advanced Balance Scale (FAB Scale)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital Lahore
state: Punjab
city: Lahore
country: Pakistan
facility: Mayo Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Asrar Yousaf, M.phil
role: PRINCIPAL_INVESTIGATOR
References: