Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

Fatigue Clinical Trial

Official title:

The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01581216
• Other study ID #: fatigue-hcb-01
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2012
• Last updated: August 10, 2015
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Barretos Cancer Hospital
• Contact: Adriana S Ferreira, PhD
• Phone: +55 17-3321-6600
• Email: asmferreira[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Fatigue related to cancer is the most common reported symptom and it prevents 91% of patients of having an active life, and in several cases, the fatigue persists for several months or even years after treatment. Fatigue does cause an impact in all dimensions of patients' quality of life and it is the main cause of reduction in patients' daily life activities.

Fatigue is reported by cancer patients in all phases of the illness as one of the most frequent symptoms, especially in cases presenting metastases.

In order to monitor fatigue, pharmacological and non-pharmacological techniques may be employed, such as physical activity. Physical exercise has shown positive results in mitigating fatigue improving cardiopulmonary functioning, physical capacity and patients' quality of life.

This study will assess the efficiency of physical activity upon controlling the fatigue and quality of life in patients with advanced stage of the disease at the end of 7 days using FACT-F subscale.

Description:

Six minute walking test: a) Patients who walk a distance ≤ 300 meters in the 6-minute walk test will make a 10 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit; b) Patients who walk 300-450 meters in the 6-minute walk test will make a 20 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit; c) Patients who walk a distance less than 450 meters in the 6-minute walk test will make a 30 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit.

Resistance exercise: Patient is assessed for the ability to use 1lb of dumbbell, if they are able to use easily then he has to use 2lb dumbbell. Dumbbell exercises during the first week are 10 repetitions, which will increase 10 repetitions per week, reaching a total of 40 repetitions on the last week. The exercises will be:

1. - shoulder flexion 0-180º;

2. - shoulder abduction and adduction;

3. - shoulder extension;

4. - elbow flexion;

5. - wrist flexion and extension;

Patients' will have monitored their blood pressure, heart/cardiac frequency ( 40-60% of HR RESERVE or 60-70% HR MAX) and oxygen saturation by way of a finger oximeter made by Digit and perceived effort = light sweating, increase HR and breathing. Daily walk in the Borg scale at the beginning, middle and end will be applied to evaluate the fatigue of the patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Be older than 18 years of age,

• Any gender

• Able to understand the study protocol,

• Functional capacity equal to or higher than 60, according to the Karnofsky scale,

• Patients with a life expectancy between 3 and 12 months,

• Patient able to ambulate independently without need for any orthotics.

Exclusion Criteria:

• Patients that use drugs in order to control fatigue (Methylphenidate, Modafinil),

• Anemic Patients (HB< 8.0 mg/dl),

• Patients with cognitive deficit,

• Uncontrolled pain higher than 5, according to Visual Analogue Scale (VAS),

• Patients currently exercising,

• Patients with congestive heart failure (CHF) (New York Heart Association functional class III or IV) or related angina.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• 10 minute walk
Patients who walk a distance = 300 meters in the 6-minute walk test will make a 10 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
• 20 minute walk
Patients who walk 300-450 meters in the 6-minute walk test will make a 20 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
• 30 minute walk
Patients who walk a distance less than 450 meters in the 6-minute walk test will make a 30 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.

Locations

Country	Name	City	State
Brazil	São Judas Tadeu Hospital	Barretos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	ESAS score and FACT-F questionnaire.	Baseline, 7 days, 14 days and 20 days after starting the intervention.	No
Secondary	Quality of life	EORTC QLQ-C30.	Baseline, 7 days, 14 days and 20 days after starting the intervention.	No
Secondary	Anxiety and Depression Evaluation	Anxiety & Depression Hospital Anxiety Depression scale (HADS)	Baseline, 7 days, 14 days and 20 days after starting the intervention.	No
Secondary	Patient impression satisfaction	Satisfaction-PGIC.	Baseline and 7 days after starting the intervention	No