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

Majadahonda Iron Gate University

Status: Completed

Conditions: Neoplasms; Fatigue

Treatments: Behavioral: Vigorous aerobic training

Study type: Interventional

Funder types: Other

Identifiers

NCT02647398

PH-UEM-04

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

A: Supervised combined training

Experimental group

Description:

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

Treatment:

Behavioral: Vigorous aerobic training

B: Supervised strength training

Active Comparator group

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)

Treatment:

Behavioral: Vigorous aerobic training