Clinical trial NCT05816187: Efficacy and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Concurrent Treatment.
Official title: Study of the Effectiveness and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Simultaneous Chemotherapy, Radiotherapy or Hormonal Treatment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Colon Cancer
Keywords: Quality of Life
Therapeutic exercise
Cancer
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Infanta Leonor
First posted: 2023-04-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Health Related Quality of Life: EORTC QLQ-30
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
Secondary outcomes:
measure: Fatigue measurement with FACIT-F
timeFrame: 1.5, 3, 6, 12 months follow up
measure: Functional capacity
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
measure: Force with manual hydraulic dynamometer.
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
measure: The five Times Sit to Stand Test (5x Sit-To-Stand Test)
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
References: