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Trial Title:
Efficacy and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Concurrent Treatment.
NCT ID:
NCT05816187
Condition:
Breast Cancer
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
Quality of Life
Therapeutic exercise
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Education program on healthy habits
Description:
6-week supervised educational program.
Arm group label:
supervised with chemotherapy, radiotherapy or hormone treatment
Arm group label:
supervised without chemotherapy, radiotherapy or hormone treatment
Intervention type:
Behavioral
Intervention name:
Habitual
Description:
The same therapeutic exercise protocol will be scheduled which will be carried out
autonomously without supervision with telephone tracking
Arm group label:
Not Supervised exercise group
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Infanta Leonor
Address:
City:
Madrid
Zip:
28031
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Infanta Leonor
Address:
City:
Madrid
Zip:
28031
Country:
Spain
Status:
Active, not recruiting
Start date:
March 15, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Universidad Complutense de Madrid
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Infanta Leonor
Agency class:
Other
Source:
Universidad Complutense de Madrid
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816187
