Web-Based Exercise for Neuropathy and Quality of Life in Breast Cancer

NCT06879678 | Completed

• 1 other identifier: Bilecik14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy is a widely used treatment method for cancer patients. However, various side effects may occur depending on the drug used, treatment duration, and dosage. One of these side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common complication that negatively affects patients' quality of life due to nerve damage. In particular, taxane-based chemotherapy drugs (e.g., docetaxel and paclitaxel), which are commonly used in the treatment of breast cancer, can lead to peripheral neuropathy. Studies indicate that the incidence of taxane-induced neuropathy ranges between 61% and 92%. While this condition primarily presents with sensory symptoms, it can also affect motor and autonomic nervous system functions in some patients. Currently, pharmacological treatments for preventing CIPN are limited. Aside from duloxetine, no medication has been proven effective. Therefore, non-pharmacological approaches, such as exercise, are considered an important alternative for alleviating neuropathy symptoms. Exercise is emerging as an effective method for preventing and managing peripheral neuropathy during cancer treatment. Research suggests that regular exercise has positive effects on the nervous system and can help reduce neuropathic symptoms, thereby improving patients' quality of life. This randomized controlled trial aims to evaluate the effects of a web-based exercise program on neuropathic symptoms and quality of life in breast cancer patients undergoing chemotherapy. The study consists of two phases: In the first phase, a web-based exercise program will be developed under the guidance of a physiotherapist to help manage neuropathic symptoms. In the second phase, the effectiveness of this program will be assessed. Data will be collected using the Patient Information Form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and the EORTC QLQ-C30 Quality of Life Questionnaire. Evaluations will be conducted before the intervention and at the end of an 8-week period in both the intervention and control groups. This study aims to demonstrate the potential effects of web-based exercise programs in alleviating neuropathic symptoms and improving quality of life in cancer patients.

Conditions

Chemotherapy-Induced Peripheral Neuropathy (CIPN); Breast Cancer

Keywords

Breast Cancer; Chemotherapy-Induced Peripheral Neuropathy (CIPN); Exercise Therapy; Quality of Life; Web-Based Intervention

Outcome Measures

Primary Outcomes (2)

• Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)

  The Turkish validity and reliability of the scale were tested in breast cancer patients receiving taxane chemotherapy (n=430). The first section assesses sensory and motor symptoms (numbness, itching, burning, discomfort, cold sensitivity, pain, weakness, balance problems), with responses scored from 0 to 10. Higher scores indicate greater discomfort. In the second section, difficulties in daily activities (e.g., dressing, walking, working, exercising) are also rated from 0 to 10. The scale's overall Cronbach alpha is 0.87, with test-retest reliability ranging from 0.90 to 0.96. These results confirm that the scale is valid and reliable for the Turkish population.

  At baseline (first visit) and at 8 weeks

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  The scale was adapted into Turkish in 2008, and its validity and reliability were determined in cancer patients. The scale consists of 30 items. It includes three subscales: functional, symptom, and global health status. The functional subscale includes physical function, role function, emotional function, cognitive function, and social function. The symptom subscale includes fatigue, nausea-vomiting, pain, shortness of breath, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. The first 28 items of the scale are based on a 4-point Likert scale. The items are rated as follows: Never: 1- Very much: 4. Higher scores in this section indicate a higher level of functional ability or symptom severity. A lower average score on the symptom subscale indicates higher quality of life.The global health status of the scale is assessed with items 29 and 30, rated on a scale 1: very poor, 7: excellent. Higher scores in this section indicate better quality of life.

  At baseline (first visit) and at 8 weeks

Study Arms (2)

Control group

NO INTERVENTION

standard protocol

Intervention group

EXPERIMENTAL

Web-Based Exercise Program + standard protocol

Behavioral: Web-Based Exercise Program

Interventions

Web-Based Exercise Program BEHAVIORAL

Web-Based Exercise Program + standard protocol

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and speak Turkish,
• Over 18 years of age,
• Receiving taxane-based chemotherapy in daytime chemotherapy units,
• Reporting at least one neuropathy symptom according to CIPNAT,
• Diagnosed with stage II-III breast cancer,
• Receiving a planned weekly taxane-based chemotherapy infusion dose (70-99 mg/m², 100-129 mg/m², 130-159 mg/m², 160 mg/m² and above) and completing 8 treatment cycles,
• Having internet access,
• No history of deep vein thrombosis,
• Not using anticoagulant medication,
• Willing to participate in the study.

You may not qualify if:

• Younger than 18 years or older than 75 years,
• Having central nervous system disorders affecting movement, balance, sensation, or coordination,
• Presence of any skin infection, scar tissue, inflammation, or incision on the hands or ankles,
• Diagnosed with a proven cardiac condition or using medication for cardiac issues,
• Pregnant women or those in the postpartum period,
• History of polyneuropathy before chemotherapy,
• Cognitive impairment,
• Presence of metal implants in the exposure area,
• History of any other malignancy,
• Undergoing mastectomy.
• Withdrawal Criteria
• Patients meeting the following conditions will be withdrawn from the study:
• Patients whose taxane treatment protocol is changed,
• Patients who wish to withdraw from the study,
• Patients with a pulse rate above 100 bpm,

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Gulhane Education and Research Hospital, Ankara, 06010

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (5)

• Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

  PMID: 25261162 BACKGROUND

• Odynets T, Briskin Y, Todorova V. Effects of Different Exercise Interventions on Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419880598. doi: 10.1177/1534735419880598.

  PMID: 31625419 BACKGROUND

• Comez S, Karayurt O. The effect of web-based training on life quality and spousal adjustment for women with breast cancer and their spouses. Eur J Oncol Nurs. 2020 Aug;47:101758. doi: 10.1016/j.ejon.2020.101758. Epub 2020 Apr 9.

  PMID: 32659714 BACKGROUND

• Bektas H, Coskun HS, Arikan F, Ozcan K, Tekeli A, Kondak Y, Sezgin MG, Yangec E, Kalav S. Development and evaluation of the efficacy of a web-based education program among cancer patients undergoing treatment with systemic chemotherapy: a randomized controlled trial. Support Care Cancer. 2022 Jul;30(7):6021-6033. doi: 10.1007/s00520-022-07039-w. Epub 2022 Apr 12.

  PMID: 35412076 BACKGROUND

• Dixit S, Tapia V, Sepulveda C, Olate D, Berrios-Contreras L, Lorca LA, Alqahtani AS, Ribeiro IL. Effectiveness of a Therapeutic Exercise Program to Improve the Symptoms of Peripheral Neuropathy during Chemotherapy: Systematic Review of Randomized Clinical Trials. Life (Basel). 2023 Jan 18;13(2):262. doi: 10.3390/life13020262.

  PMID: 36836620 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• SABAHAT COŞKUN, Doç.Dr.

  Bilecik Şeyh Edebali Üniversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: The study population will consist of breast cancer patients who receive taxane-based chemotherapy and meet the inclusion criteria at the Day Chemotherapy Unit of a training and research hospital. A sample size calculation has been conducted for the study. Before conducting the power analysis, the effect size must be determined. In this study, the effect size has been derived from a similar previous study. Based on this study, the Type-1 error (α) is set at 0.05, power (1-β) is 0.85, and the effect size (d = 0.60) for the Student's t-test has been calculated. Based on these parameters, the minimum required sample size was 82 (41 per group), and we planned to recruit 90 to account for attrition. Overall, 95 patients were enrolled (47 control, 48 intervention), and after exclusions (control: 2 hospitalized; intervention: 2 protocol changes, 1 withdrawal due to severe symptoms), the study was completed with 90 patients (45 per group).

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 17, 2025
• Study Start: May 28, 2025
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)