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

Sponsor

Universidad de Granada (Other)

Overall Status

Recruiting

CT.gov ID

NCT03787966

Collaborator

(none)

110

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Other: ATOPE-B Other: ATOPE-I	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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).	Other: ATOPE-B Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment. Other Names: Therapeutic exercise before medical treatment
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).	Other: ATOPE-I Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment. Other Names: Therapeutic exercise during medical treatment

Arm

Intervention/Treatment

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).

Other: ATOPE-B

Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.

Other Names:

Therapeutic exercise before medical treatment

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).

Other: ATOPE-I

Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.

Other Names:

Therapeutic exercise during medical treatment

Outcome Measures

Primary Outcome Measures

Left ventricular ejection fraction [Participants will be followed over 12 months]
To assess cardiac toxicity by echocardiography

Secondary Outcome Measures

Cardiovascular events [Participants will be followed over 12 months]
Number of cardiovascular events registered in a diary
Resting heart rate [Participants will be followed over 12 months]
To assess cardiac function by a Holter
Heart Rate variability [Participants will be followed over 12 months]
To assess cardiac autonomic system balance by a Holter
Muscle loss [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 [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. [Participants will be followed over 12 months but will not be assessed in baseline]
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 [Participants will be followed over 12 months]
type of chemotherapy agent used and number of sessions.
Chemotherapy doses modifications [Participants will be followed over 12 months]
delay of doses or reduction, total doses received from the total expected.
Early session termination. [Participants will be followed over 12 months]
Patient stopped receiving chemotherapy before last >=1 sessions.
Missing bouts due to adverse effects of chemotherapy [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. [Participants will be followed over 12 months]
Therapeutic exercise bout modification [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 [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. [Participants will be followed over 12 months]
Frequency of serious and non-serious events occurring during program.
Functional capacity [Participants will be followed over 12 months]
assessed by the 6-Minute Walking Test
Handgrip strength [Participants will be followed over 12 months]
assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan
Shoulder strength [Participants will be followed over 12 months]
assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Lower limb strength [Participants will be followed over 12 months]
assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Abdominal strength [Participants will be followed over 12 months]
assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Flexibility [Participants will be followed over 12 months]
assessed by the Modified sit-and-reach test
Waist and hip circumferences [Participants will be followed over 12 months]
assessed by an inelastic tape
Body composition [Participants will be followed over 12 months]
assessed by the InBody
Oxidative stress [Participants will be followed over 12 months]
Thiobarbituric acid reactive substances (TBARS)
Oxidative stress [Participants will be followed over 12 months]
carbonyls and 8-hydroxy-2' -deoxyguanosine (8-OHdG)
Inmune function [Participants will be followed over 12 months]
Number of lymphocytes: (cluster of differentiation (CD) 8 and 4 and regulatory T lymphocytes)
inflammation [Participants will be followed over 12 months]
C-reactive protein (CRP)
inflammation [Participants will be followed over 12 months]
interleukin (IL) 6 and 10
inflammation [Participants will be followed over 12 months]
tumor necrosis factor (TNF) alpha
inflammation [Participants will be followed over 12 months]
insulin-like growth factor 1 (IGF-1)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.).