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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Neoplasms, Fatigue

Intervention / Treatment
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* Behavioral: Vigorous aerobic training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Supervised combined training<br>INTERVENTION: Two supervised 75 min-vigorous aerobic training & strength training | Behavioral: Vigorous aerobic training<br>* Supervised vigorous aerobic training<br>|
| Active Comparator: B: Supervised strength training<br>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<br>* Supervised vigorous aerobic training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer survivors, training, exercise, cancer-related fatigue