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Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program (ATOPE)

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ClinicalTrials.gov Identifier: NCT03787966
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Irene Cantarero Villanueva, Universidad de Granada

Tracking Information
First Submitted Date  ICMJE December 14, 2018
First Posted Date  ICMJE December 27, 2018
Last Update Posted Date April 22, 2019
Estimated Study Start Date  ICMJE April 29, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
Left ventricular ejection fraction [ Time Frame: Participants will be followed over 12 months ]
To assess cardiac toxicity by echocardiography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03787966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • Cardiovascular events [ Time Frame: Participants will be followed over 12 months ]
    Number of cardiovascular events registered in a diary
  • Resting heart rate [ Time Frame: Participants will be followed over 12 months ]
    To assess cardiac function by a Holter
  • Heart Rate variability [ Time Frame: Participants will be followed over 12 months ]
    To assess cardiac autonomic system balance by a Holter
  • Muscle loss [ Time Frame: Participants will be followed over 12 months ]
    To assess muscle mass loss by Inbody
  • Quality of life with the Quality of Life Questionnaire (QLQ)-C30 [ Time Frame: Participants will be followed over 12 months ]
    With the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures. Values are assigned between 1 and 4 (1: not at all, 2: a little, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 evaluate with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of cancer impact on the patient of each of the scales. The high values in the scales of global health and function state indicate a better CV, while in the scale of symptoms it would indicate a decrease in CV since it indicates the presence of symptoms associated with cancer.
  • Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module. [ Time Frame: Participants will be followed over 12 months ]
    European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. After the scoring procedures for the QLQ-C30, all scale and single-item scores are linearly transformed to a 0 to 100 scale. For the functional scales and single items (ie, body image, sexuality, and future perspective), higher scores represent a better level of functioning. For the symptom scales and single item, a higher score represents a higher level of symptoms.
  • Chemotherapy regimen [ Time Frame: Participants will be followed over 12 months ]
    type of chemotherapy agent used and number of sessions.
  • Chemotherapy doses modifications [ Time Frame: Participants will be followed over 12 months ]
    delay of doses or reduction, total doses received from the total expected.
  • Early session termination. [ Time Frame: Participants will be followed over 12 months ]
    Patient stopped receiving chemotherapy before last >=1 sessions.
  • Missing bouts due to adverse effects of chemotherapy [ Time Frame: Participants will be followed over 12 months ]
    Adverse effects of chemotherapy treatment and if it was interrupted (>=3 missing consecutive bouts of exercise)
  • Number of hospitalizations. [ Time Frame: Participants will be followed over 12 months ]
  • Therapeutic exercise bout modification [ Time Frame: Participants will be followed over 12 months ]
    >=1 bout that required a dose modification during the program and number of bouts modified in total.
  • Time to treatment failure [ Time Frame: Participants will be followed over 12 months ]
    days from the start to the end of chemotherapy, if it was terminated for toxicity and/or tumor progression.
  • Program adverse effects reported by the participants. [ Time Frame: Participants will be followed over 12 months ]
    Frequency of serious and non-serious events occurring during program.
  • Functional capacity [ Time Frame: Participants will be followed over 12 months ]
    assessed by the 6-Minute Walking Test
  • Handgrip strength [ Time Frame: Participants will be followed over 12 months ]
    assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan
  • Shoulder strength [ Time Frame: Participants will be followed over 12 months ]
    assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
  • Lower limb strength [ Time Frame: Participants will be followed over 12 months ]
    assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
  • Abdominal strength [ Time Frame: Participants will be followed over 12 months ]
    assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
  • Flexibility [ Time Frame: Participants will be followed over 12 months ]
    assessed by the Modified sit-and-reach test
  • Waist and hip circumferences [ Time Frame: Participants will be followed over 12 months ]
    assessed by an inelastic tape
  • Body composition [ Time Frame: Participants will be followed over 12 months ]
    assessed by the InBody
  • Oxidative stress [ Time Frame: Participants will be followed over 12 months ]
    Thiobarbituric acid reactive substances (TBARS)
  • Oxidative stress [ Time Frame: Participants will be followed over 12 months ]
    carbonyls and 8-hydroxy-2' -deoxyguanosine (8-OHdG)
  • Inmune function [ Time Frame: Participants will be followed over 12 months ]
    Number of lymphocytes: (cluster of differentiation (CD) 8 and 4 and regulatory T lymphocytes)
  • inflammation [ Time Frame: Participants will be followed over 12 months ]
    C-reactive protein (CRP)
  • inflammation [ Time Frame: Participants will be followed over 12 months ]
    interleukin (IL) 6 and 10
  • inflammation [ Time Frame: Participants will be followed over 12 months ]
    tumor necrosis factor (TNF) alpha
  • inflammation [ Time Frame: Participants will be followed over 12 months ]
    insulin-like growth factor 1 (IGF-1)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program
Official Title  ICMJE Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program: Study Protocol of the ATOPE Trial in Women Recently Diagnosed With Breast Cancer
Brief Summary The aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.
Detailed Description

The positive relationship between physical exercise and cancer is widely justified in the literature, but an emerging research line warns of its capacity to improve the effectiveness and reduce the toxicity of cancer treatment (responsible for the appearance of side effects and comorbidities), that overload the health care system. To date, there is a lack of knowledge in different subjects: the possibility of implementing individualized exercise programs in clinical environment to mitigate the side effects of cancer treatment; the best moment in natural history of the disease to perform therapeutic exercise; and a tailored dose of exercise that maximizes its benefits.

In this context, the present study will evaluate the effects of a therapeutic exercise program conducted previously at the beginning of the cancer treatment, in the treatments' toxicity against the same program conducted during cancer treatments in women with breast cancer, and its positive effects on both clinical and biological variables and their possible impact on disease-free survival.

This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot study be carried out to check the feasibility of the proposed physical exercise program; phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical treatment against the same made during treatment, with a randomized controlled clinical trial; and phase 3: in which it will be integrated into the health service and a larger project will be requested at the international level.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Other: ATOPE-B
    Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.
    Other Name: Therapeutic exercise before medical treatment
  • Other: ATOPE-I
    Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.
    Other Name: Therapeutic exercise during medical treatment
Study Arms  ICMJE
  • Experimental: ATOPE-B
    An adapted therapeutic exercise program performed before medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).
    Intervention: Other: ATOPE-B
  • Active Comparator: ATOPE-I
    An adapted therapeutic exercise program performed during medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).
    Intervention: Other: ATOPE-I
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Breast cancer diagnosis I-III stage
  • On the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy.
  • If they meet other criteria which predisposes to higher toxicity.
  • Have signed informed consent.
  • Have medical clearance for participation.

Exclusion Criteria:

  • Patient underwent previous cancer treatments.
  • Patients were previously diagnosed with cancer.
  • Pregnant patients.
  • Patients performing other type of therapeutic exercise at diagnosis time with an intake >or = to 150 moderate-intensity or 75 min of vigorous-intensity a day.
  • Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis >70%, metastasis etc.).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Irene Cantarero-Villanueva, PhD 958248764 irenecantarero@ugr.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787966
Other Study ID Numbers  ICMJE ATOPE18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Irene Cantarero Villanueva, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Irene Cantarero-Villanueva, PhD Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
PRS Account Universidad de Granada
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP