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

NCT06737926 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/24/0204
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemotherapy Induced Peripheral Neuropathy; Breast Cancer Patients

Keywords

Breast Cancer; Chemotherapy-Induced Peripheral Neuropathy; Postural Balance; Sensorimotor Neuropathy; Exercise

Outcome Measures

Primary Outcomes (4)

• Numeric Pain Rating Scale (NPRS)

  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.

  6 weeks

• TUG Test

  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

  6 weeks

• Activities-Specific Balance Confidence Scale

  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 weeks

• 6-Minute Walk Test

  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

  6 weeks

Secondary Outcomes (3)

• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale

  6 weeks

• EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)

  6 weeks

• Fullerton Advanced Balance Scale (FAB Scale)

  6 weeks

Study Arms (2)

Group A: Experimental Group receiving Sensorimotor Training Exercise.

EXPERIMENTAL

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

Behavioral: Sensorimotor Training Exercise

Group B: Control Group receiving Conventional Exercise Therapy.

ACTIVE COMPARATOR

Participants will receive conventional exercise therapy as per standard guidelines.

Behavioral: Conventional Exercise Therapy

Interventions

Sensorimotor Training Exercise BEHAVIORAL

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.

Group A: Experimental Group receiving Sensorimotor Training Exercise.

Conventional Exercise Therapy BEHAVIORAL

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.

Group B: Control Group receiving Conventional Exercise Therapy.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females with invasive ductal carcinoma, stages I-III
• Age ranged between 30-65 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Links

• Twice-weekly neuromuscular stimulation training reduced the incidence of chemotherapy-induced peripheral neuropathy compared with standard care, especially among patients taking vinca alkaloids.

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Muhammad Asrar Yousaf, M.phil

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: January 15, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)