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

Randomized Study Comparing Two Strategies of Physical Activity in Long-term Breast and Colon Cancer Survivors and Their Impact on Fatigue

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Fatigue
• Intervention / Treatment: Behavioral: Vigorous aerobic training

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:

1. cardiorespiratory fitness,
2. quality of life;
3. adherence to the training program;
4. adherence to international recommendations,
5. body composition,
6. employment status

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro-Majadahonda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: Supervised combined training; INTERVENTION: Two supervised 75 min-vigorous aerobic training & strength training	Behavioral: Vigorous aerobic training; Supervised vigorous aerobic training
Active Comparator: B: Supervised 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)	Behavioral: Vigorous aerobic training; Supervised vigorous aerobic training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in cancer related-fatigue	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cardiorespiratory fitness	measured through CPET	4 months
Changes in quality of life	measured through EORTC QLQ C30	4 months
adherence to the program		4 months
adherence to international recommendations	measured by accelerometer	4 months
Changes in body composition	measured by DEXA (Dual Energy X-Ray Absortiometry)	4 months
Employment status		4 months

Collaborators and Investigators

• Sponsor: Puerta de Hierro University Hospital
• Collaborators: Universidad Europea de Madrid
• Investigators: Study Director: Itziar Pagola, PhD, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 3, 2016
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: exercise; training; Cancer survivors; cancer-related fatigue
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: PH-UEM-04