NCT02647398

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

January 3, 2016

Last Update Submit

April 4, 2018

Conditions

NeoplasmsFatigue

Keywords

Cancer survivorstrainingexercisecancer-related fatigue

Outcome Measures

Primary Outcomes (1)

  • Improvement in cancer related-fatigue

    4 months

Secondary Outcomes (6)

  • Changes in cardiorespiratory fitness

    4 months

  • Changes in quality of life

    4 months

  • adherence to the program

    4 months

  • adherence to international recommendations

    4 months

  • Changes in body composition

    4 months

  • +1 more secondary outcomes

Study Arms (2)

A: Supervised combined training

EXPERIMENTAL

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

Behavioral: Vigorous aerobic training

B: Supervised strength training

ACTIVE COMPARATOR

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

Interventions

Vigorous aerobic trainingBEHAVIORAL

Supervised vigorous aerobic training

A: Supervised combined trainingB: Supervised strength training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • mobility limitation
  • treatment with beta-blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

NeoplasmsFatigueMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Itziar Pagola, PhD

    Universidad Europea de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

ES(1)