Chemotherapeutic ToxicityNCT04663178
Foot Bath and Chemotherapy Induced Fatigue
A study testing Warm Salt Water Foot Bath in people with Chemotherapeutic Toxicity and Chemotherapy-induced Fatigue, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Background: In a limited number of studies conducted with the participation of cancer patients, it has been reported that warm water bath may be beneficial for management of cancer-related fatigue. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapeutic Toxicity, Chemotherapy-induced Fatigue
- What is being tested?
- Warm Salt Water Foot Bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2017to 28 Feb 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving adjuvant or neoadjuvant chemotherapy with the diagnosis of early stage cancer
- Having fatigue severity of 3 and >3
- Agreeing to participate in the study.
Who cannot join
- Having the complaint of peripheral neuropathy.
- Being diagnosed with diabetes
- Having impaired skin integrity.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Outpatient Chemotherapy Unit of the Institute of Oncology in Istanbul University
Istanbul, Sisli, 34384
About this study
Official title: The Effect of Warm Salt Water Foot Bath on the Management of Chemotherapy Induced Fatigue
Background: In a limited number of studies conducted with the participation of cancer patients, it has been reported that warm water bath may be beneficial for management of cancer-related fatigue.
Objective: This experimental study was conducted to evaluate the effect of warm salt water foot bath applied to reduce the chemotherapy-induced fatigue.
Read more
Interventions/Methods: Seventy-nine patients who were experiencing moderate or higher level of fatigue were included in this study conducted between November 2017-February 2018. 42 of the patients were assigned to the experimental group and 37 patients were assigned to the control group. A training booklet about chemotherapy-induced fatigue were given to all patients. In addition, the experimental group was asked to perform 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath. Subsequently, the patients were called by phone every day for one week to record their fatigue levels.
Results: The 7-day fatigue course of both groups was similar. However the physical, emotional, affective and cognitive distress related to fatigue decreased in the experimental group but did not decrease in the control group.
Conclusion: The warm salt water footbath may be an effective approach in enhancing fatigue related quality of life. However, it is needed to conduct more comprehensive studies to express the effectiveness.
Implications to Practice: Nurses can propose the use of the warm salt water footbath in the management of chemotherapy induced fatigue.
Keywords: Chemotherapy Induced Fatigue, Warm salt water foot bath
Read the detailed description
Cancer is an important health problem that is seen frequently in the society and causes a large number of people to lose their lives today. Turkey Statistics Institute's report stating that 81.129 people living in Turkey lost their lives in 2018 due to cancer has further increased the importance of this issue.
The main treatment approaches used in the treatment of cancer are surgical treatment, chemotherapy, and radiotherapy. Being one of these treatment approaches, chemotherapy causes many side effects such as low blood count, fatigue, alopecia, change in taste/smell, nausea-vomiting, mucositis, constipation, diarrhoea, loss of appetite, and neuropathy and adversely affects the quality of life and compliance to treatment. Fatigue, which is one of these problems, is one of the main problems that is frequently reported by patients and adversely affects the daily activities of patients. The incidence of fatigue in patients undergoing chemotherapy has been reported to be 82-96%. Many studies have reported that 30% of patients continue to experience fatigue feeling even in the post-treatment period. Many patients have expressed that they have difficulty in performing activities of daily living and experience difficulty in focusing, lack of strength, apathy towards activities, mood disorders, and loss of sexual desire due to fatigue. Therefore, extensive examination and management of fatigue are important to ensure the compliance to treatment in these patients, increase the treatment efficacy, and enhance their quality of lives.
In the literature, the use of many pharmacological and non-pharmacological approaches in the management of chemotherapy-induced fatigue is recommended. While pharmacological approaches such as methylphenidate, modafinil, and erythrocyte transfusion ensure patients to cope with fatigue by generally treating the problems causing the development of fatigue, non-pharmacological approaches such as training of the patients as well as their families, increasing activity level, yoga, Tai-Chi and Reiki practice, cognitive behavioural therapy approach, energy saving, nutrition regulation, music therapy and massage strengthen patients and support them to cope with fatigue.
This experimental study was conducted in the Outpatient Chemotherapy Unit of the Institute of Oncology in Istanbul University between 15 November 2017 and 28 February 2018 after obtaining institutional permission and ethics committee approval. After giving information about the study, the patients who agreed to participate in the study were divided into experimental (n = 38) or control (n = 37) groups using a randomisation list prepared by random number method in Excel program by the researcher. Interactive training and training booklet containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to both groups. In addition; in order to cope with chemotherapy-induced fatigue, the experimental group patients were asked 1 day after the treatment to apply warm salt water bath of 41-42ºC once a day for 20 minutes between 21:00-22:00 at home for 7 days and when chemotherapy related fatigue was at the highest level. By using 10-minute video previously prepared by the researcher, how the patient will prepare and apply the temperature of the warm salt water of 41-42oC and the salt rate (280 grams of table salt to 8 litres of water) to be used for footbath were shown and explained.
- Being tested
- Warm Salt Water Foot Bath
- Keywords
- Chemotherapy Induced Fatigue, Warm salt water foot bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Salt Water Foot BathOther
A training booklet about chemotherapy-induced fatigue + 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath.
| Study group | Role | What they receive |
|---|---|---|
| Warm Salt Water Foot Bath Group | Experimental | In the first interview Patient Identification Form, Fatigue Severity and Piper Fatigue Scale (PFS) were applied to the patients. A training booklet about chemotherapy-induced fatigue containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to patients.
Each patient received iodine salt and a liquid thermometer to measure the temperature of the water. The patients were asked 1 day after the treatment to apply warm salt water bath of 41-42ºC once a day for 20 minutes for 7 days.
Subsequently, the fatigue level of the patients was evaluated 30 minutes after having a warm saltwater foot bath and recorded by questioning via calling them with phone every day and using the Visual Fatigue Scale for 7 days. In the last interview PFS was used to evaluate the effect level of fatigue on the quality of life and the assessment process was completed. Receives: Other: Warm Salt Water Foot Bath |
| Control Group | No intervention | A training booklet about chemotherapy-induced fatigue In the first interview Patient Identification Form, Fatigue Severity and Piper Fatigue Scale were applied to the patients. A training booklet about chemotherapy-induced fatigue containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to experimental group. Subsequently, the fatigue level of the patients was evaluated and recorded by questioning via calling them with phone every day and using the Visual Fatigue Scale for 7 days. The patients were evaluated in the evening. In the last interview conducted with the patient on the 7th day, Piper's Fatigue Scale was used to evaluate the effect level of fatigue on the quality of life and the assessment process was completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
This form, which was prepared by the researcher in accordance with the literature and consisting of seven sections, contains 29 questions evaluating the personal characteristics of the patients, the characteristics of the disease and the treatment process, and the functional adequacy of the patient.
Measured: One week
Fatigue Severity
The severity of fatigue was classified depending on NCI-CTCAE v3.0 adverse events classification system for fatigue: "0" for "I am not tired", "1" for "I am slightly tired, relieved by rest"; "2" for "I am moderately tired, not relieved by rest"; "3" for "I am very tired, not relieved by rest and is limited instrumental activities of daily living", "4" for "I am extremely tired", fatigue is not relieved by rest and is limited self-care activities of daily living.
Measured: One week
Piper Fatigue Scale
The questions the fatigue-related behavioural, affective, sensory and cognitive distress level of the patients in 22 items and 4 subscales. In each item of the scale, emotions that may be felt due to fatigue are ranged from 1 (weak) to 10 (strong). The person defines his/her fatigue he/she experiences at that moment by marking the best answer (number) reflecting it. Fatigue-related subscale scores (behavioural, affective, sensory and cognitive) are obtained by summing the scores of all items in that subscale and dividing the resulting score to number of items. The overall fatigue score is obtained by summing the score of all items and dividing them by the total number of items. The subscale and general scale score ranges from 0 to 10 and the increased score indicates increased perceived fatigue. There are also 5 open-ended questions in the scale and these questions are not included in the score calculation of fatigue perception.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start15 Nov 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda AKYUZ OZDEMIR, MsCN, Istanbul University - Cerrahpasa
- Investigators
- Ferda AKYUZ OZDEMIR, Principal investigator, IUC Florence Nıghtingale Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663178
- Sponsor's protocol ID
- Warm Salt Water Foot Bath
- Status last verified
- Sep 2023
- First submitted
- 2 Dec 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Warm Salt Water Foot Bath on the Management of Chemotherapy Induced Fatigue
- ClinicalTrials.gov ID
- NCT04663178
- Acronym / sponsor ID
- Warm Salt Water Foot Bath
- Keywords
- Chemotherapy Induced Fatigue, Warm salt water foot bath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 10 Dec 2020 (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.
Background: In a limited number of studies conducted with the participation of cancer patients, it has been reported that warm water bath may be beneficial for management of cancer-related fatigue.
Objective: This experimental study was conducted to evaluate the effect of warm salt water foot bath applied to reduce the chemotherapy-induced fatigue.
Interventions/Methods: Seventy-nine patients who were experiencing moderate or higher level of fatigue were included in this study conducted between November 2017-February 2018. 42 of the patients were assigned to the experimental group and 37 patients were assigned to the control group. A training booklet about chemotherapy-induced fatigue were given to all patients. In addition, the experimental group was asked to perform 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath. Subsequently, the patients were called by phone every day for one week to record their fatigue levels.
Results: The 7-day fatigue course of both groups was similar. However the physical, emotional, affective and cognitive distress related to fatigue decreased in the experimental group but did not decrease in the control group.
Conclusion: The warm salt water footbath may be an effective approach in enhancing fatigue related quality of life. However, it is needed to conduct more comprehensive studies to express the effectiveness.
Implications to Practice: Nurses can propose the use of the warm salt water footbath in the management of chemotherapy induced fatigue.
Keywords: Chemotherapy Induced Fatigue, Warm salt water foot bath
Detailed description
Cancer is an important health problem that is seen frequently in the society and causes a large number of people to lose their lives today. Turkey Statistics Institute's report stating that 81.129 people living in Turkey lost their lives in 2018 due to cancer has further increased the importance of this issue.
The main treatment approaches used in the treatment of cancer are surgical treatment, chemotherapy, and radiotherapy. Being one of these treatment approaches, chemotherapy causes many side effects such as low blood count, fatigue, alopecia, change in taste/smell, nausea-vomiting, mucositis, constipation, diarrhoea, loss of appetite, and neuropathy and adversely affects the quality of life and compliance to treatment. Fatigue, which is one of these problems, is one of the main problems that is frequently reported by patients and adversely affects the daily activities of patients. The incidence of fatigue in patients undergoing chemotherapy has been reported to be 82-96%. Many studies have reported that 30% of patients continue to experience fatigue feeling even in the post-treatment period. Many patients have expressed that they have difficulty in performing activities of daily living and experience difficulty in focusing, lack of strength, apathy towards activities, mood disorders, and loss of sexual desire due to fatigue. Therefore, extensive examination and management of fatigue are important to ensure the compliance to treatment in these patients, increase the treatment efficacy, and enhance their quality of lives.
In the literature, the use of many pharmacological and non-pharmacological approaches in the management of chemotherapy-induced fatigue is recommended. While pharmacological approaches such as methylphenidate, modafinil, and erythrocyte transfusion ensure patients to cope with fatigue by generally treating the problems causing the development of fatigue, non-pharmacological approaches such as training of the patients as well as their families, increasing activity level, yoga, Tai-Chi and Reiki practice, cognitive behavioural therapy approach, energy saving, nutrition regulation, music therapy and massage strengthen patients and support them to cope with fatigue.
This experimental study was conducted in the Outpatient Chemotherapy Unit of the Institute of Oncology in Istanbul University between 15 November 2017 and 28 February 2018 after obtaining institutional permission and ethics committee approval. After giving information about the study, the patients who agreed to participate in the study were divided into experimental (n = 38) or control (n = 37) groups using a randomisation list prepared by random number method in Excel program by the researcher. Interactive training and training booklet containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to both groups. In addition; in order to cope with chemotherapy-induced fatigue, the experimental group patients were asked 1 day after the treatment to apply warm salt water bath of 41-42ºC once a day for 20 minutes between 21:00-22:00 at home for 7 days and when chemotherapy related fatigue was at the highest level. By using 10-minute video previously prepared by the researcher, how the patient will prepare and apply the temperature of the warm salt water of 41-42oC and the salt rate (280 grams of table salt to 8 litres of water) to be used for footbath were shown and explained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Warm Salt Water Foot Bath Group | Experimental | Other: Warm Salt Water Foot BathIn the first interview Patient Identification Form, Fatigue Severity and Piper Fatigue Scale (PFS) were applied to the patients. A training booklet about chemotherapy-induced fatigue containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to patients. Each patient received iodine salt and a liquid thermometer to measure the temperature of the water. The patients were asked 1 day after the treatment to apply warm salt water bath of 41-42ºC once a day for 20 minutes for 7 days. Subsequently, the fatigue level of the patients was evaluated 30 minutes after having a warm saltwater foot bath and recorded by questioning via calling them with phone every day and using the Visual Fatigue Scale for 7 days. In the last interview PFS was used to evaluate the effect level of fatigue on the quality of life and the assessment process was completed. |
| Control Group | No intervention | –A training booklet about chemotherapy-induced fatigue In the first interview Patient Identification Form, Fatigue Severity and Piper Fatigue Scale were applied to the patients. A training booklet about chemotherapy-induced fatigue containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to experimental group. Subsequently, the fatigue level of the patients was evaluated and recorded by questioning via calling them with phone every day and using the Visual Fatigue Scale for 7 days. The patients were evaluated in the evening. In the last interview conducted with the patient on the 7th day, Piper's Fatigue Scale was used to evaluate the effect level of fatigue on the quality of life and the assessment process was completed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving adjuvant or neoadjuvant chemotherapy with the diagnosis of early stage cancer
- Having fatigue severity of 3 and >3
- Agreeing to participate in the study.
Key exclusion criteria (3 listed)
- Having the complaint of peripheral neuropathy.
- Being diagnosed with diabetes
- Having impaired skin integrity.
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 |
|---|---|---|
| Warm Salt Water Foot BathA training booklet about chemotherapy-induced fatigue + 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath. | Other | Warm Salt Water Foot Bath Group |
Primary outcome
Patient Identification Form
Time frame: One week
This form, which was prepared by the researcher in accordance with the literature and consisting of seven sections, contains 29 questions evaluating the personal characteristics of the patients, the characteristics of the disease and the treatment process, and the functional adequacy of the patient.
Fatigue Severity
Time frame: One week
The severity of fatigue was classified depending on NCI-CTCAE v3.0 adverse events classification system for fatigue: "0" for "I am not tired", "1" for "I am slightly tired, relieved by rest"; "2" for "I am moderately tired, not relieved by rest"; "3" for "I am very tired, not relieved by rest and is limited instrumental activities of daily living", "4" for "I am extremely tired", fatigue is not relieved by rest and is limited self-care activities of daily living.
Piper Fatigue Scale
Time frame: One week
The questions the fatigue-related behavioural, affective, sensory and cognitive distress level of the patients in 22 items and 4 subscales. In each item of the scale, emotions that may be felt due to fatigue are ranged from 1 (weak) to 10 (strong). The person defines his/her fatigue he/she experiences at that moment by marking the best answer (number) reflecting it. Fatigue-related subscale scores (behavioural, affective, sensory and cognitive) are obtained by summing the scores of all items in that subscale and dividing the resulting score to number of items. The overall fatigue score is obtained by summing the score of all items and dividing them by the total number of items. The subscale and general scale score ranges from 0 to 10 and the increased score indicates increased perceived fatigue. There are also 5 open-ended questions in the scale and these questions are not included in the score calculation of fatigue perception.
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 28 Sep 2023.
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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.
Ferda AKYUZ OZDEMIR principal investigator
IUC Florence Nıghtingale Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Salt Water Foot Bath in people with Chemotherapeutic Toxicity and Chemotherapy-induced Fatigue, run by Istanbul University - Cerrahpasa 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 3 inclusion and 3 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 28 Sep 2023. 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?
Patient Identification Form (time frame: One week). The study lists 3 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 28 Sep 2023.