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

NCT05816187 | Completed DMC

• 1 other identifier: Internal Code 012-23
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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 INTERVENTION: two treatment groups: supervised therapeutic exercise and control group. Tho groups will be supervised in performing PET for a period of 6 weeks and the other group will receive the usual care. 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.

Conditions

Breast Cancer; Colon Cancer

Keywords

Quality of Life; Therapeutic exercise; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fatigue measurement with FACIT-F

  1.5, 3, 6, 12 months follow up

• Functional capacity

  Basal, 1.5, 3, 6, 12 months follow up

• Force with manual hydraulic dynamometer.

  Basal, 1.5, 3, 6, 12 months follow up

• The five Times Sit to Stand Test (5x Sit-To-Stand Test)

  Basal, 1.5, 3, 6, 12 months follow up

Study Arms (2)

Supervised exercise

EXPERIMENTAL

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.

Behavioral: Education program on healthy habits

Usual care

NO INTERVENTION

Subjects receive usual care

Interventions

Education program on healthy habits BEHAVIORAL

6-week supervised educational program.

Supervised exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Hospital Universitario Infanta Leonor: collaborator

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: March 15, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 22, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-09

Locations

ES (1)