Efficacy and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Concurrent Treatment.

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Breast Cancer; Colon Cancer

Treatments: Behavioral: Education program on healthy habits; Behavioral: Habitual

Study type: Interventional

Funder types: Other

Identifiers

NCT05816187

Internal Code 012-23

Details and patient eligibility

About

OBJECTIVE: To evaluate the effectiveness of a PET scan in oncological patients, with and without simultaneous treatment with chemotherapy, radiotherapy or hormonal therapy, in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention. DESIGN: Randomized controlled clinical trial, parallel groups with active control group. With randomization blinding, patient assessment and data analysis. STUDY SUBJECTS: 78 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (aromatase inhibitors, tamoxifen). INTERVENTION: three treatment groups: supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy, radiotherapy or hormonal treatment, supervised therapeutic exercise group with simultaneous chemotherapy, radiotherapy or hormonal treatment and control group. Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised. Patients will be followed for 1 year, with five blinded assessments: at baseline, after 6 weeks of intervention, 3, 6 and 12 months after baseline. MEASUREMENTS: Main: Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Measured pre-post intervention, 3, 6 and 12 months. Secondary: Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Measured pre-post intervention, 3, 6 and 12 months. Functional capacity measured with the 6-minute walk test. Pre-post intervention measurement, 3, 6 and 12 months. Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test. Pre-post intervention measurement, 3, 6 and 12 months.

Full description

OBJECTIVE: To evaluate the effectiveness of a PET scan in oncological patients, with and without simultaneous treatment with chemotherapy, radiotherapy or hormonal therapy, in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention. DESIGN: Randomized controlled clinical trial, parallel groups with active control group. With randomization blinding, patient assessment and data analysis. STUDY SUBJECTS: 78 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (aromatase inhibitors, tamoxifen). INTERVENTION: three treatment groups: supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy, radiotherapy or hormonal treatment, supervised therapeutic exercise group with simultaneous chemotherapy, radiotherapy or hormonal treatment and control group. Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised. Patients will be followed for 1 year, with five blinded assessments: at baseline, after 6 weeks of intervention, 3, 6 and 12 months after baseline. MEASUREMENTS: Main: Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Measured pre-post intervention, 3, 6 and 12 months. Secondary: Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Measured pre-post intervention, 3, 6 and 12 months. Functional capacity measured with the 6-minute walk test. Pre-post intervention measurement, 3, 6 and 12 months. Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test. Pre-post intervention measurement, 3, 6 and 12 months.COST

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-70 years.
• Oncological stage I, II or III.
• Completed adjuvant treatment between 3 months to 2 years. ECOG 1-2.
• Sign informed consent

Exclusion criteria

• Inability to read, understand and complete questionnaires, read and understand a brochure explanatory, understand and follow verbal orders (example; illiteracy, dementia or blindness).
• Musculoskeletal disorders that prevent the exercise of the exercise bike, elliptical, march tape.
• Important neurological disorders that involve impaired balance, coordination, ataxia.
• Sporting activity at moderate intensity exceeding 150mnts / week.
• Symptomatic anemia.
• Fecal incontinence
• Patient with a digestive ostomy.
• Decompensated heart disease,
• Uncontrolled hypertension
• Heart failure.
• Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom)
• Cardio-respiratory pathology that limits physical activity

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

supervised without chemotherapy, radiotherapy or hormone treatment

Experimental group

Description:

Therapeutic exercise program based on aerobic work, strength-endurance and self-stretching of 6 weeks duration, in addition to a reinforcement of the usual self-care recommendations.

Treatment:

Behavioral: Education program on healthy habits

supervised with chemotherapy, radiotherapy or hormone treatment

Experimental group

Description:

Therapeutic exercise program based on aerobic work, strength-endurance and self-stretching of 6 weeks duration, in addition to a reinforcement of the usual self-care recommendations.

Treatment:

Behavioral: Education program on healthy habits

Not Supervised exercise group

Active Comparator group

Description:

Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.

Treatment:

Behavioral: Habitual