Clinical trial NCT04663178: Foot Bath and Chemotherapy Induced Fatigue
Official title: The Effect of Warm Salt Water Foot Bath on the Management of Chemotherapy Induced Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapeutic Toxicity
Chemotherapy-induced Fatigue
Keywords: Chemotherapy Induced Fatigue
Warm salt water foot bath
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Having the complaint of peripheral neuropathy.
* Being diagnosed with diabetes
* Having impaired skin integrity.

Primary outcomes:
measure: Patient Identification Form
timeFrame: One week
measure: Fatigue Severity
timeFrame: One week
measure: Piper Fatigue Scale
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Outpatient Chemotherapy Unit of the Institute of Oncology in Istanbul University
state: Sisli
Study officials:
affiliation: IUC Florence Nıghtingale Nursing Faculty
name: Ferda AKYUZ OZDEMIR
role: PRINCIPAL_INVESTIGATOR
References: