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

Breast Cancer Clinical Trial

Official title:

Study of the Effectiveness and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Simultaneous Chemotherapy, Radiotherapy or Hormonal Treatment.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05816187
• Other study ID #: Internal Code 012-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: September 2025

Study information

• Verified date: March 2023
• Source: Universidad Complutense de Madrid
• Contact: Arturo Cano
• Phone: 34611165586
• Email: arcano01[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: September 2025
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colonic Neoplasms

Intervention

Behavioral:
• Education program on healthy habits
6-week supervised educational program.
• Habitual
The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Leonor	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Hospital Universitario Infanta Leonor

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Health Related Quality of Life: EORTC QLQ-30	(EORTC QLQ-30). The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.	Basal, 1.5, 3, 6, 12 months follow up
Secondary	Fatigue measurement with FACIT-F	Fatigue measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire.; The FACIT-F 13-item scale is designed on a 5-point Likert scale (0 = nothing; 1 = little; 2 = something; 3 = a lot; 4 = very much). The FACIT-F scale is designed so that a high score is good, the possible score is 0 to 52, 0 being the worst possible and 52 the best.	1.5, 3, 6, 12 months follow up
Secondary	Functional capacity	The 6-minute walk test consists of measuring the maximum distance that the patient is able to walk in 6 minutes, on a tour short in a hallway, simultaneously assessing heart rate, oxygen saturation and degree of dyspnea. Usually healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex	Basal, 1.5, 3, 6, 12 months follow up
Secondary	Force with manual hydraulic dynamometer.	Valuation of the measured force with manual hydraulic dynamometer . The prehensile force exerted during 5 seconds will be measured, it will be done 3 times and the average will be taken.	Basal, 1.5, 3, 6, 12 months follow up
Secondary	The five Times Sit to Stand Test (5x Sit-To-Stand Test)	Valuation of the functional lower extremity strength with the The five Times Sit to Stand Test (5x Sit-To-Stand Test), The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back (43-45 cm, 17-18 inches high). Then the instruction is given by asking the test taker to sit on the chair by resting their back. Also, the test taker is instructed to fold their arms across their chest. Then the test taker should be instructed to do sit-to-stand five times, as quickly as possible, at the count of go and without their back or leg resting on the chair between the interval of repetition.; The lower the time to complete the test the better the outcome of the test.	Basal, 1.5, 3, 6, 12 months follow up