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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647398
• Other study ID #: PH-UEM-04
• Status: Completed
• Phase: N/A
• First received: January 3, 2016
• Last updated: April 4, 2018
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Fatigue
• Neoplasms

Intervention

Behavioral:
• Vigorous aerobic training
Supervised vigorous aerobic training

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital	Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in cancer related-fatigue		4 months
Secondary	Changes in cardiorespiratory fitness	measured through CPET	4 months
Secondary	Changes in quality of life	measured through EORTC QLQ C30	4 months
Secondary	adherence to the program		4 months
Secondary	adherence to international recommendations	measured by accelerometer	4 months
Secondary	Changes in body composition	measured by DEXA (Dual Energy X-Ray Absortiometry)	4 months
Secondary	Employment status		4 months