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OpenTrials
Completed

NCT Number: NCT02647398

Study Comparing Two Strategies of Exercise in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, 28222, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vigorous aerobic training

Behavioral

Supervised vigorous aerobic training

Primary outcomes

  1. Improvement in cancer related-fatigue

    Time frame: 4 months

Secondary outcomes

  1. Changes in cardiorespiratory fitness

    Time frame: 4 months

    measured through CPET

  2. Changes in quality of life

    Time frame: 4 months

    measured through EORTC QLQ C30

  3. adherence to the program

    Time frame: 4 months

  4. adherence to international recommendations

    Time frame: 4 months

    measured by accelerometer

  5. Changes in body composition

    Time frame: 4 months

    measured by DEXA (Dual Energy X-Ray Absortiometry)

  6. Employment status

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Collaborators

  • Universidad Europea de Madrid

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2016
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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