Chemotherapy-Induced Peripheral Neuropathy (CIPN)NCT06879678
Web-Based Exercise for Neuropathy and Quality of Life in Breast Cancer
A study testing Web-Based Exercise Program in people with Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Breast Cancer, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy (CIPN), Breast Cancer
- What is being tested?
- Web-Based Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2025to 16 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- Having internet access,
- No history of deep vein thrombosis,
- Not using anticoagulant medication,
- Willing to participate in the study.
Who cannot join
- 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,
Show all 17Show fewer
- 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,
- Patients receiving fewer than four weekly chemotherapy applications,
- Women without internet access or those who do not visit the website at least five times for four hours throughout the follow-up period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Education and Research Hospital, Ankara, 06010
Ankara, 06010
About this study
Official title: Evaluating a Web-Based Exercise Program for Neuropathic Symptoms and Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Tria
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.
Read more
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.
Read the detailed description
Breast cancer is the most common type of cancer among women worldwide and in our country, ranking second among the leading causes of cancer-related deaths. Chemotherapy drugs are among the most widely used treatment methods for breast cancer. Peripheral neuropathy (PN) is one of the most common side effects caused by chemotherapy drugs, characterized by damage to the nervous system. This condition is specific to all chemotherapy drug classes and can develop even after a single drug administration. However, in most cases, it increases depending on the dose and duration of the drug, especially in elderly patients, those with diabetes, alcohol users, individuals with metabolic disorders, and those with vitamin B12 deficiency. Furthermore, the mechanisms responsible for the development of peripheral neuropathy have not yet been thoroughly elucidated.
The clinical symptoms of chemotherapy-induced peripheral neuropathy (CIPN) include tingling, numbness, muscle weakness, loss of balance, changes in touch, pain, and temperature perception, as well as constipation, postural hypotension, and loss of deep tendon reflexes. The early detection of CIPN symptoms can prevent disability, falls, and injuries, minimizing the progression of symptoms and complications. Otherwise, the presence and severity of neuropathic pain can negatively impact walking, daily activities, sleep, work, mood, enjoyment of life, and interpersonal relationships. This, in turn, can lead to a decline in patients' quality of life. Additionally, in patients experiencing these issues, dose reductions, treatment cancellations, or delays can adversely affect the treatment process and survival rates. In this context, the inability to tolerate the full dose and duration of chemotherapy due to CIPN emerges as a significant oncological issue.
There is limited evidence-based intervention to continue treatment and prevent or alleviate CIPN. Therefore, more research is needed on non-pharmacological supportive strategies to manage the burden of CIPN and improve patients' quality of life. One of the interventions with the potential to prevent or alleviate CIPN and consequently improve quality of life is exercise rehabilitation. Exercise programs play an important role in managing chemotherapy-induced side effects and improving patients' physical fitness and quality of life. Moreover, exercise programs have been found to positively impact peripheral nerves, inducing beneficial changes in vascular and metabolic systems, stimulating blood flow, and contributing to oxygen delivery.
Additionally, women who engage in moderate to vigorous physical activity before chemotherapy treatment have a lower risk of developing CIPN. Evidence-based studies have tested the positive effects of different types of exercise (aerobic, endurance, balance, and motor-sensory exercises) in reducing CIPN symptoms and improving quality of life. Most cancer patients receive chemotherapy on an outpatient basis and must manage the side effects that develop after treatment at home. During this process, cancer patients often lack professional support. Therefore, cancer patients and their families need to be supported not only in hospital settings but also at home.
Recently, there has been a rapid increase in the number of web-based education programs developed for cancer patients, which have been shown to be effective in increasing patients' knowledge levels, providing psychosocial support, reducing anxiety and depression levels, and improving quality of life. A randomized controlled web-based and mobile-supported intervention developed for women with breast cancer has been found beneficial in managing symptoms related to chronic pain and lymphedema. Furthermore, it has been observed that breast cancer patients can easily use web-based education programs and find them informative for both themselves and their families.
In this context, web-based educational programs and applications can provide interactive, cost-effective, efficient, and appropriate content for all users, including patients, families, and healthcare professionals. Delivering exercise training and follow-ups via the web can be a significant advantage for patients facing transportation difficulties, those with various physical barriers, or those who prefer the comfort and convenience of home. Planning web-based programs according to the needs of cancer patients can enhance their usage rates and effectiveness.
This study has been designed as a randomized controlled trial to evaluate the effectiveness of a web-based exercise program on neuropathic symptoms and quality of life in breast cancer patients undergoing chemotherapy.
- Being tested
- Web-Based Exercise Program
- Keywords
- Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy (CIPN), Exercise Therapy, Quality of Life, Web-Based Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Exercise ProgramBehavioural
Web-Based Exercise Program + standard protocol
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | standard protocol |
| Intervention group | Experimental | Web-Based Exercise Program + standard protocol Receives: Behavioral: Web-Based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (first visit) and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start28 May 2025
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 randomized (47 control, 48 intervention). Five discontinued participation (control: 2 hospitalizations; intervention: 2 taxane regimen changes, 1 withdrawal due to severe symptoms). Eight-week assessments and complete-case analyses included 90 patients (45 per group).
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahat Coşkun, Bilecik Seyh Edebali Universitesi
- Investigators
- SABAHAT COŞKUN, Doç.Dr., Study director, Bilecik Şeyh Edebali Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879678
- Sponsor's protocol ID
- Bilecik14
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon request, in accordance with ethical guidelines and with participant consent.
Publications
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.
PubMed 25261162Odynets 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.
PubMed 31625419Comez 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.
PubMed 32659714Bektas 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.
PubMed 35412076Dixit 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.
PubMed 36836620
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Web-Based Exercise Program for Neuropathic Symptoms and Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Tria
- ClinicalTrials.gov ID
- NCT06879678
- Acronym / sponsor ID
- Bilecik14
- Keywords
- Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy (CIPN), Exercise Therapy, Quality of Life, Web-Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the most common type of cancer among women worldwide and in our country, ranking second among the leading causes of cancer-related deaths. Chemotherapy drugs are among the most widely used treatment methods for breast cancer. Peripheral neuropathy (PN) is one of the most common side effects caused by chemotherapy drugs, characterized by damage to the nervous system. This condition is specific to all chemotherapy drug classes and can develop even after a single drug administration. However, in most cases, it increases depending on the dose and duration of the drug, especially in elderly patients, those with diabetes, alcohol users, individuals with metabolic disorders, and those with vitamin B12 deficiency. Furthermore, the mechanisms responsible for the development of peripheral neuropathy have not yet been thoroughly elucidated.
The clinical symptoms of chemotherapy-induced peripheral neuropathy (CIPN) include tingling, numbness, muscle weakness, loss of balance, changes in touch, pain, and temperature perception, as well as constipation, postural hypotension, and loss of deep tendon reflexes. The early detection of CIPN symptoms can prevent disability, falls, and injuries, minimizing the progression of symptoms and complications. Otherwise, the presence and severity of neuropathic pain can negatively impact walking, daily activities, sleep, work, mood, enjoyment of life, and interpersonal relationships. This, in turn, can lead to a decline in patients' quality of life. Additionally, in patients experiencing these issues, dose reductions, treatment cancellations, or delays can adversely affect the treatment process and survival rates. In this context, the inability to tolerate the full dose and duration of chemotherapy due to CIPN emerges as a significant oncological issue.
There is limited evidence-based intervention to continue treatment and prevent or alleviate CIPN. Therefore, more research is needed on non-pharmacological supportive strategies to manage the burden of CIPN and improve patients' quality of life. One of the interventions with the potential to prevent or alleviate CIPN and consequently improve quality of life is exercise rehabilitation. Exercise programs play an important role in managing chemotherapy-induced side effects and improving patients' physical fitness and quality of life. Moreover, exercise programs have been found to positively impact peripheral nerves, inducing beneficial changes in vascular and metabolic systems, stimulating blood flow, and contributing to oxygen delivery.
Additionally, women who engage in moderate to vigorous physical activity before chemotherapy treatment have a lower risk of developing CIPN. Evidence-based studies have tested the positive effects of different types of exercise (aerobic, endurance, balance, and motor-sensory exercises) in reducing CIPN symptoms and improving quality of life. Most cancer patients receive chemotherapy on an outpatient basis and must manage the side effects that develop after treatment at home. During this process, cancer patients often lack professional support. Therefore, cancer patients and their families need to be supported not only in hospital settings but also at home.
Recently, there has been a rapid increase in the number of web-based education programs developed for cancer patients, which have been shown to be effective in increasing patients' knowledge levels, providing psychosocial support, reducing anxiety and depression levels, and improving quality of life. A randomized controlled web-based and mobile-supported intervention developed for women with breast cancer has been found beneficial in managing symptoms related to chronic pain and lymphedema. Furthermore, it has been observed that breast cancer patients can easily use web-based education programs and find them informative for both themselves and their families.
In this context, web-based educational programs and applications can provide interactive, cost-effective, efficient, and appropriate content for all users, including patients, families, and healthcare professionals. Delivering exercise training and follow-ups via the web can be a significant advantage for patients facing transportation difficulties, those with various physical barriers, or those who prefer the comfort and convenience of home. Planning web-based programs according to the needs of cancer patients can enhance their usage rates and effectiveness.
This study has been designed as a randomized controlled trial to evaluate the effectiveness of a web-based exercise program on neuropathic symptoms and quality of life in breast cancer patients undergoing chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 randomized (47 control, 48 intervention). Five discontinued participation (control: 2 hospitalizations; intervention: 2 taxane regimen changes, 1 withdrawal due to severe symptoms). Eight-week assessments and complete-case analyses included 90 patients (45 per group).
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –standard protocol |
| Intervention group | Experimental | Behavioral: Web-Based Exercise ProgramWeb-Based Exercise Program + standard protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Exercise ProgramWeb-Based Exercise Program + standard protocol | Behavioural | Intervention group |
Primary outcome
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
Time frame: At baseline (first visit) and at 8 weeks
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.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: At baseline (first visit) and at 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 25261162Seretny 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.
- Background: PubMed 31625419Odynets 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.
- Background: PubMed 32659714Comez 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.
- Background: PubMed 35412076Bektas 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.
- Background: PubMed 36836620Dixit 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon request, in accordance with ethical guidelines and with participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SABAHAT COŞKUN, Doç.Dr. study director
Bilecik Şeyh Edebali Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Exercise Program in people with Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Breast Cancer, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) (time frame: At baseline (first visit) and at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879678, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.