Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD

Stem Cell Transplant Complications Clinical Trial

Official title:

Physical Therapy in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation With a Diagnosis of Chronic Graft-versus-host Disease: A Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279585
• Other study ID #: ECA GVHD
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: University of Seville
• Contact: Raquel P Aguilar, PhDcand
• Phone: 955 013 260
• Email: raquelijorml[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD.

Description:

Design: Prospective controlled clinical trial.

Location: Virgen del Rocío University Hospital, Hematology Unit.

Statistical analysis plan:The data will be analyzed using SPSS v.26 software for Windows and Epidat 4.2. All statistical tests will be conducted considering a 95% confidence interval (p-value <0.05). To compare the score of the main outcome measure, quality of life (score range 0-200), between the experimental and control groups, the t-test or Mann-Whitney test will be employed (depending on the normality of the data). The comparison will be conducted at three time points (T0, T1, and T2). Furthermore, multivariate analysis will be performed using generalized equations of repeated measures to determine score changes between the groups. Since it is a Likert scale-based score, the Friedman test will be used to compare score changes, employing the Bonferroni test for pairwise comparisons.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: September 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic Graft-Versus-Host Disease (cGVHD) treated at Virgen del Rocío University Hospital will be invited to participate in the trial (n=108), under the following eligibility criteria: Inclusion criteria:

• Adult (18 years or older); Underwent allogeneic hematopoietic stem cell transplantation (alloHSCT) diagnosed with cGVHD; No medical contraindication for moderate or high-intensity exercise; Proficiency in the Spanish language; Have access to the internet.

Exclusion Criteria:

• Unable to perform initial or final physical assessments; Having serious pre-existing conditions before the oncological diagnosis or diseases that are not or poorly controlled; Not signing or delivering the informed consent on the indicated date.

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Graft vs Host Disease
• Graft-versus-host-disease
• Hematologic Cancer
• Hematologic Neoplasms
• Hematological Malignancy
• Stem Cell Transplant Complications

Intervention

Other:
• Physical therapy
Health education sessions and combined therapeutic exercise sessions, based on muscular strength training and cardiorespiratory endurance.

Locations

Country	Name	City	State
Spain	University of Seville; Manuel Siurot Avenue, no number	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life	MEASURE NAME: Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT); VERSION: 4; NUMBER OF ITEMS: 50; RESPONSE SCALE: 5 point Likert-type scale; SCORING:Manual scoring template, some items are reverse scored. Higher score represents better quality of life.	Week 1, Week 6, and Week 13
Primary	Chronic Graft-Versus-Host Disease (cGVHD) symptom burden	Modified Lee Chronic Graft-Versus-Host Disease Symptom Scale (mLSS) for 7 days. This is an instrument with 7 domains (skin, eyes, mouth, lungs, nutrition, energy, and psychiatry) and a total of 28 items to assess. The response options for "Please inform us if any of the following problems have bothered you in the last 7 days" range from 0 to 4 (Not at all, A little, Moderately, Quite a bit, Extremely). A difference of 5 to 6 points (standard deviation) will be considered clinically significant. Subscales range from 0 to 100, with a higher score indicating worse symptoms.	Week 1, Week 6, and Week 13
Secondary	Muscular strength	Sit-to- Stand test y Handrig strength test	Week 1, Week 6, and Week 13
Secondary	Cardiorespiratory fitness	2-min Walk Test	Week 1, Week 6, and Week 13
Secondary	Functional status	Human Activity Profile (HAP)	Week 1, Week 6, and Week 13
Secondary	Distress	Distress-Thermometer	Week 1, Week 6, and Week 13
Secondary	Mood	"Mood Assessment Scale" (MAS); Designed to assess transient mood states, both positive and negative, in any individual at any time, through 16 items divided into four scales (depression, anxiety, hostility, and joy), each defined by 4 items and evaluated using the Likert scale, with scores ranging from 0 to 10. The values for each category are calculated by the mean. All 16 statements have the same structure; they all begin with the phrase "I feel" and end with an adjective describing a mood state.	Week 1, Week 6, and Week 13
Secondary	Anxiety	Hospital Anxiety and Depression Scale (HADS) questionnaire; The "Hospital Anxiety and Depression Scale questionnaire" (HADS); a useful tool for identifying anxiety and depression states in cancer patients and applicable during clinical practice. The two categories consist of one subscale each, with seven items rated from 0 to 4 points, with higher scores (in the range of 0 to 21) indicating anxious and depressive states. Participants should respond considering how they felt and/or behaved during the last seven days.	Week 1, Week 6, and Week 13
Secondary	Biological markers	Cytokines (interleukins) and lymphocytic populations as part of routine analysis. Blood sample.	Week 1, Week 6, and Week 13
Secondary	Responses to medical treatment	NIH Criteria	Week 1, Week 6, and Week 13