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

Breast Neoplasms Clinical Trial

— ATOPE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787966
• Other study ID #: ATOPE18
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2023
• Source: Universidad de Granada
• Contact: Irene Cantarero-Villanueva, PhD
• Phone: 958248764
• Email: irenecantarero[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• ATOPE-B
Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.
• ATOPE-I
Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction	To assess cardiac toxicity by echocardiography	Participants will be followed over 12 months
Secondary	Cardiovascular events	Number of cardiovascular events registered in a diary	Participants will be followed over 12 months
Secondary	Resting heart rate	To assess cardiac function by a Holter	Participants will be followed over 12 months
Secondary	Heart Rate variability	To assess cardiac autonomic system balance by a Holter	Participants will be followed over 12 months
Secondary	Muscle loss	To assess muscle mass loss by Inbody	Participants will be followed over 12 months
Secondary	Quality of life with the Quality of Life Questionnaire (QLQ)-C30	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.	Participants will be followed over 12 months
Secondary	Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module.	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.	Participants will be followed over 12 months but will not be assessed in baseline
Secondary	Chemotherapy regimen	type of chemotherapy agent used and number of sessions.	Participants will be followed over 12 months
Secondary	Chemotherapy doses modifications	delay of doses or reduction, total doses received from the total expected.	Participants will be followed over 12 months
Secondary	Early session termination.	Patient stopped receiving chemotherapy before last >=1 sessions.	Participants will be followed over 12 months
Secondary	Missing bouts due to adverse effects of chemotherapy	Adverse effects of chemotherapy treatment and if it was interrupted (>=3 missing consecutive bouts of exercise)	Participants will be followed over 12 months
Secondary	Number of hospitalizations.		Participants will be followed over 12 months
Secondary	Therapeutic exercise bout modification	>=1 bout that required a dose modification during the program and number of bouts modified in total.	Participants will be followed over 12 months
Secondary	Time to treatment failure	days from the start to the end of chemotherapy, if it was terminated for toxicity and/or tumor progression.	Participants will be followed over 12 months
Secondary	Program adverse effects reported by the participants.	Frequency of serious and non-serious events occurring during program.	Participants will be followed over 12 months
Secondary	Functional capacity	assessed by the 6-Minute Walking Test	Participants will be followed over 12 months
Secondary	Handgrip strength	assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan	Participants will be followed over 12 months
Secondary	Shoulder strength	assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)	Participants will be followed over 12 months
Secondary	Lower limb strength	assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)	Participants will be followed over 12 months
Secondary	Abdominal strength	assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)	Participants will be followed over 12 months
Secondary	Flexibility	assessed by the Modified sit-and-reach test	Participants will be followed over 12 months
Secondary	Waist and hip circumferences	assessed by an inelastic tape	Participants will be followed over 12 months
Secondary	Body composition	assessed by the InBody	Participants will be followed over 12 months
Secondary	Oxidative stress	Thiobarbituric acid reactive substances (TBARS)	Participants will be followed over 12 months
Secondary	Oxidative stress	carbonyls and 8-hydroxy-2' -deoxyguanosine (8-OHdG)	Participants will be followed over 12 months
Secondary	Inmune function	Number of lymphocytes: (cluster of differentiation (CD) 8 and 4 and regulatory T lymphocytes)	Participants will be followed over 12 months
Secondary	inflammation	C-reactive protein (CRP)	Participants will be followed over 12 months
Secondary	inflammation	interleukin (IL) 6 and 10	Participants will be followed over 12 months
Secondary	inflammation	tumor necrosis factor (TNF) alpha	Participants will be followed over 12 months
Secondary	inflammation	insulin-like growth factor 1 (IGF-1)	Participants will be followed over 12 months