Chemotherapeutic ToxicityNCT06012253
The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life
A study testing Home Based Walking Program in people with Chemotherapeutic Toxicity, run by Akdeniz University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study aims to evaluate the effect of home-based walking program on peripheral neuropathy, fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapeutic Toxicity
- What is being tested?
- Home Based Walking Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 20 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Being bone and brain metastases
- Being peripheral neuropathy due to reasons other than chemotherapy (such as chronic disease, diabetes mellitus, nutritional disorders)
- Skin sensitivity on the hands and feet
- Having cardiovascular, pulmonary, musculoskeletal, or psychological disorders that limit exercise or mobility
- Being in another supportive program
- Being in the very active category according to the "International Physical Activity Scale (IPAQ- Short Form)"
- Being a severity of more than 4 points according to the "Modified Borg Scale (MBS)"
- Being a score of 2 and above according to the "ECOG Performance Scale"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life in Patients Receiving Taxane and Platinum-Based Chemotherapy
The study aims to evaluate the effect of home-based walking program on peripheral neuropathy, fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy.
Read the detailed description
The study was designed as a randomized controlled trial. This study will be carried out with a total of 88 cancer patients receiving taxane and platinum-based chemotherapy, 44 of whom were in the intervention group and 44 in the control group, whose treatment was started in Akdeniz University Hospital."Home Based Walking Program" will be applied to the patients in the intervention group for 8 weeks.Within the scope of the Home-Based Walking Program, face-to-face patient education, patient education booklet, sending text messages, face-to-face and telephone counseling were planned.
Patient Identification Form, International Physical Activity Questionnaire (IPAQ- Short Form), National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria, Cancer Fatigue Scale, EORTC QLQ-CIPN20 (Quality of Life Chemotherapy-Induced Peripheral Neuropathy) and EORTC QLQ-C30 (Quality of Life Scale), Interview Form will be used to collect data.
- Conditions
- Chemotherapeutic Toxicity
- Being tested
- Home Based Walking Program
- Keywords
- Home-based walking program, Chemotherapy, Cancer, Peripheral neuropathy, Fatigue, Quality of life, Nurse
- Medical subject headings
- Neoplasms, Peripheral Nervous System Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Walking ProgramOther
The intervention group will be applied to "Home Based Walking Program". It was aimed that the patients should do at least 150 minutes of moderate-intensity physical exercise per week for up to 8 weeks. The content of the program includes a walking information booklet (information notes, activity chart and obstacle avoidance form), exercise diary, face-to-face-telephone counseling, sending text messages, prepared in line with international guides. It was planned to give weekly counseling to the patients included in the intervention group for an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| Home Based Walking Program | Experimental | Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life Receives: Other: Home Based Walking Program |
| Control group | No intervention | The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (IPAQ- Short Form)
It is used to evaluate physical activity. The form includes walking, moderate and vigorous activity, sitting categories. The total score includes the sum of time (minutes) and frequency (days).
Measured: Baseline and 8th week
National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria
This scale was developed to evaluate the grading of chemotherapy-related peripheral neurotoxicity. It evaluates sensory and motor neuropathy between grades 1-5.
Measured: Baseline and 8th week
Cancer Fatigue Scale
This scale was developed to evaluate the fatigue of cancer patients. It includes 15 questions and three sub-dimensions: Physical, Affective and Cognitive. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of fatigue.
Measured: Baseline and 8th week
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)
This scale was developed to evaluate the effect of peripheral neuropathy on quality of life of cancer patients. It includes 20 questions and three sub-dimensions: Sensory, Motor and Autonomic. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of symptoms and problems related to peripheral neuropathy.
Measured: Baseline and 8th week
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: Global health status, Functional, Symptom. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good quality of life.
Measured: Baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start15 Sep 2023
- Primary completion30 Aug 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic ToxicityStudies 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
- This is a randomized controlled trial consisting of two groups: experimental and control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hava Kara, Akdeniz University
- Investigators
- Fatma Arikan, PhD, RN, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012253
- Sponsor's protocol ID
- "70904504/376"
- Status last verified
- Jun 2025
- First submitted
- 19 Aug 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life in Patients Receiving Taxane and Platinum-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT06012253
- Acronym / sponsor ID
- "70904504/376"
- Conditions
- Chemotherapeutic Toxicity
- Keywords
- Home-based walking program, Chemotherapy, Cancer, Peripheral neuropathy, Fatigue, Quality of life, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Akdeniz University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 25 Aug 2023 (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.
The study aims to evaluate the effect of home-based walking program on peripheral neuropathy, fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy.
Detailed description
The study was designed as a randomized controlled trial. This study will be carried out with a total of 88 cancer patients receiving taxane and platinum-based chemotherapy, 44 of whom were in the intervention group and 44 in the control group, whose treatment was started in Akdeniz University Hospital."Home Based Walking Program" will be applied to the patients in the intervention group for 8 weeks.Within the scope of the Home-Based Walking Program, face-to-face patient education, patient education booklet, sending text messages, face-to-face and telephone counseling were planned.
Patient Identification Form, International Physical Activity Questionnaire (IPAQ- Short Form), National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria, Cancer Fatigue Scale, EORTC QLQ-CIPN20 (Quality of Life Chemotherapy-Induced Peripheral Neuropathy) and EORTC QLQ-C30 (Quality of Life Scale), Interview Form will be used to collect data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial consisting of two groups: experimental and control
| Arm | Type | Receives |
|---|---|---|
| Home Based Walking Program | Experimental | Other: Home Based Walking ProgramEffect of home-based walking program on peripheral neuropathy, fatigue and quality of life |
| Control group | No intervention | –The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Being bone and brain metastases
- Being peripheral neuropathy due to reasons other than chemotherapy (such as chronic disease, diabetes mellitus, nutritional disorders)
- Skin sensitivity on the hands and feet
- Having cardiovascular, pulmonary, musculoskeletal, or psychological disorders that limit exercise or mobility
- Being in another supportive program
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 |
|---|---|---|
| Home Based Walking ProgramThe intervention group will be applied to "Home Based Walking Program". It was aimed that the patients should do at least 150 minutes of moderate-intensity physical exercise per week for up to 8 weeks. The content of the program includes a walking information booklet (information notes, activity chart and obstacle avoidance form), exercise diary, face-to-face-telephone counseling, sending text messages, prepared in line with international guides. It was planned to give weekly counseling to the patients included in the intervention group for an 8-week period. | Other | Home Based Walking Program |
Primary outcome
International Physical Activity Questionnaire (IPAQ- Short Form)
Time frame: Baseline and 8th week
It is used to evaluate physical activity. The form includes walking, moderate and vigorous activity, sitting categories. The total score includes the sum of time (minutes) and frequency (days).
National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria
Time frame: Baseline and 8th week
This scale was developed to evaluate the grading of chemotherapy-related peripheral neurotoxicity. It evaluates sensory and motor neuropathy between grades 1-5.
Cancer Fatigue Scale
Time frame: Baseline and 8th week
This scale was developed to evaluate the fatigue of cancer patients. It includes 15 questions and three sub-dimensions: Physical, Affective and Cognitive. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of fatigue.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)
Time frame: Baseline and 8th week
This scale was developed to evaluate the effect of peripheral neuropathy on quality of life of cancer patients. It includes 20 questions and three sub-dimensions: Sensory, Motor and Autonomic. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of symptoms and problems related to peripheral neuropathy.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Baseline and 8th week
This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: Global health status, Functional, Symptom. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good 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 18 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Fatma Arikan, PhD, RN study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Walking Program in people with Chemotherapeutic Toxicity, run by Akdeniz University Hospital 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 0 inclusion and 8 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 18 Jun 2025. 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?
International Physical Activity Questionnaire (IPAQ- Short Form) (time frame: Baseline and 8th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.