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Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue

Primary Purpose

Neoplasms, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vigorous aerobic training
Sponsored by
Puerta de Hierro University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms focused on measuring Cancer survivors, training, exercise, cancer-related fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65
  • history of breast or colon cancer
  • no evidence of disease
  • end of treatment in the last five years
  • able to understand the questionnaire PERFORM
  • able to manage the accelerometer

Exclusion Criteria:

  • mobility limitation
  • treatment with beta-blockers
  • exclusion criteria for CPET

Sites / Locations

  • Hospital Universitario Puerta de Hierro-Majadahonda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Supervised combined training

B: Supervised strength training

Arm Description

INTERVENTION: Two supervised 75 min-vigorous aerobic training & strength training

ACTIVE COMPARATOR: Two supervised 45-minute sessions of strength training & Participants will be advised to comply with international recommendations of physical activity (150 min pf MVPA)

Outcomes

Primary Outcome Measures

Improvement in cancer related-fatigue

Secondary Outcome Measures

Changes in cardiorespiratory fitness
measured through CPET
Changes in quality of life
measured through EORTC QLQ C30
adherence to the program
adherence to international recommendations
measured by accelerometer
Changes in body composition
measured by DEXA (Dual Energy X-Ray Absortiometry)
Employment status

Full Information

First Posted
January 3, 2016
Last Updated
April 4, 2018
Sponsor
Puerta de Hierro University Hospital
Collaborators
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02647398
Brief Title
Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue
Official Title
Randomized Study Comparing Two Strategies of Physical Activity in Long-term Breast and Colon Cancer Survivors and Their Impact on Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Puerta de Hierro University Hospital
Collaborators
Universidad Europea de Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.
Detailed Description
Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48. The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week. After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment. Secondary objectives include: cardiorespiratory fitness, quality of life; adherence to the training program; adherence to international recommendations, body composition, employment status

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Fatigue
Keywords
Cancer survivors, training, exercise, cancer-related fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Supervised combined training
Arm Type
Experimental
Arm Description
INTERVENTION: Two supervised 75 min-vigorous aerobic training & strength training
Arm Title
B: Supervised strength training
Arm Type
Active Comparator
Arm Description
ACTIVE COMPARATOR: Two supervised 45-minute sessions of strength training & Participants will be advised to comply with international recommendations of physical activity (150 min pf MVPA)
Intervention Type
Behavioral
Intervention Name(s)
Vigorous aerobic training
Intervention Description
Supervised vigorous aerobic training
Primary Outcome Measure Information:
Title
Improvement in cancer related-fatigue
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Changes in cardiorespiratory fitness
Description
measured through CPET
Time Frame
4 months
Title
Changes in quality of life
Description
measured through EORTC QLQ C30
Time Frame
4 months
Title
adherence to the program
Time Frame
4 months
Title
adherence to international recommendations
Description
measured by accelerometer
Time Frame
4 months
Title
Changes in body composition
Description
measured by DEXA (Dual Energy X-Ray Absortiometry)
Time Frame
4 months
Title
Employment status
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 history of breast or colon cancer no evidence of disease end of treatment in the last five years able to understand the questionnaire PERFORM able to manage the accelerometer Exclusion Criteria: mobility limitation treatment with beta-blockers exclusion criteria for CPET
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itziar Pagola, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Puerta de Hierro-Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain

12. IPD Sharing Statement

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Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue

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