Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation at the Hospital Israelita Albert Einstein
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation
Sponsor: Hospital Israelita Albert Einstein

Centro de Oncologia e Hematologia Einstein Família Dayan – Daycoval 
 
 
 
Maria Ester Azevedo Massola 
Nelson Hamerschlak 
 
 
 
 
 
 
 
Impact of Yoga and Gentle Massage Practices on 
Symptom Management in Patients Undergoing 
Hematopoietic Stem Cell Transplantation at the 
Hospital Israelita Albert Einstein 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
São Paulo 
2023 

1. Introduction 
1.1 Hematopoietic Stem Cell Transplantation (HSCT) 
This project aims to observe the impact of yoga practices on symptom management in patients 
undergoing Hematopoietic Stem Cell Transplantation (HSCT) at the Israelite Albert Einstein 
Hospital - Morumbi Unit. The clinical use of HSCT as a new form of cancer treatment was 
developed by the Fred Hutchinson Cancer Center in Seattle, USA. The first HSCT was 
performed in 1957, under the direction of Edward Donnall Thomas, MD, who was awarded the 
Nobel Prize in 1990 for his groundbreaking work (1)(2). HSCT, also known as Bone Marrow 
Transplant (BMT), began in Brazil in 1979 at the Hospital das Clínicas of the Federal University 
of Paraná. In 1983, it was implemented in another public service, the National Cancer Institute 
(INCA) in Rio de Janeiro. In 1987, the Israelite Albert Einstein Hospital was the first private 
institution to perform HSCT, using a unique type of transplant in Brazil at the time: autologous 
transplant, with the patient's own frozen marrow. Today, the HSCT unit has performed more 
than 1,300 transplants, and HIAE is the only hospital in Latin America to obtain FACT 
(Foundation for the Accreditation of Cellular Therapy) accreditation (1). HSCT is a complex and 
costly procedure performed only in specialized centers. HSCT has become a standard 
treatment for many patients with congenital or acquired disorders, malignant or non-malignant 
diseases, and remains associated with significant morbidity and mortality. It requires a vast 
network of specialists from various fields of medicine in its process (2)(3). The treatment 
involves risks, is lengthy, and predisposes the patient to various complications that require rapid 
management to ensure the life, survival, and quality of life of individuals. In addition to physical 
problems, emotional and social changes that occur throughout the process must be observed. 
Special attention should be given to social isolation in the early stages of treatment, as well as 
feelings of fear and distress that often affect both the patient and their family members (4). This 
treatment is used to replace the patient's bone marrow when it is defective due to diseases or 
not functioning properly. There are three types of HSCT: 
 
Autologous: performed with the patient's own cells, collected from the marrow or 
through peripheral blood, frozen, and stored (cryopreserved). After collection and 
cryopreservation, the patient undergoes a high-dose chemotherapy regimen, with or 
without radiation therapy, called conditioning, aimed at eliminating diseased cells, which 
consequently leads to the destruction of the patient's bone marrow. After conditioning, 
the previously collected stem cells are thawed and infused into the patient, a process 
similar to a blood transfusion. 
 
Allogeneic: performed using stem cells from a donor, who can be a relative or not. The 
degree of compatibility is determined by a set of genes located on chromosome number 
6. The analysis is performed in the laboratory, using blood samples from the donor and 
the patient, known as human leukocyte antigen (HLA) testing. The patient's siblings are 
the relatives most likely to be 100% compatible. When the marrow donor is a relative, 
the transplant is called related allogeneic, and when not, it is called unrelated 
allogeneic. It is also possible to perform a related transplant with 50% compatible 
donors, known as haploidentical transplantation, usually done through the father or 
mother. 
 
Syngeneic: The procedure is exactly the same as allogeneic, but in this case, the 
donor and the recipient are identical twins. 
Most transplants are indicated for hematological diseases. Autologous HSCT is usually 
indicated for Multiple Myeloma (MM) and Lymphomas. It can also be used to treat solid tumors, 
such as germ cell tumors, Neuroblastomas, Ewing's Sarcoma, and Meduloblastoma. For 
allogeneic HSCT, the main indications are Acute Myeloid Leukemia (AML), Acute Lymphoblastic 
Leukemia (ALL), Myelodysplastic Syndromes, and Myeloproliferative Neoplasms. 
Hematopoietic stem cell transplantation can also be used to treat a variety of non-malignant 
conditions, such as Severe Aplastic Anemia (SAA), Sickle Cell Anemia, Thalassemia, Hereditary 
Immunodeficiency Syndromes, and certain metabolic disorders (2)(3). When the bone marrow 

starts functioning again (usually around 2 to 4 weeks after cell infusion), it is said to have 
"engrafted," and the transplant is considered successful. Rigorous medical monitoring remains 
essential, as complications can still arise even a year after the procedure. New reduced-
intensity conditioning regimens have been developed, reducing toxicity, which has expanded the 
use of HSCT to older patients or those with comorbidities. Over the last two decades, there has 
been rapid expansion and continuous evolution in transplant protocols, and new indications are 
constantly being evaluated (5). Complications resulting from HSCT can be divided into three 
categories, based on time: 
1. Pre-engraftment period: from the start of the conditioning regimen until neutrophil 
recovery. Patients may experience pancytopenia, gastrointestinal toxicities, infections 
(the most common being gram-positive and gram-negative bacteria, herpes, 
candidiasis, and invasive aspergillosis), and organ dysfunction. Organ failure and even 
death can occur. The risks vary depending on the type of transplant, the conditioning 
regimen, the underlying disease, and the recipient's comorbidities. 
2. Early post-engraftment period: from neutrophil recovery to generally 100 days post-
transplant. Acute Graft-Versus-Host Disease (GVHD) can occur early in this post-
engraftment period. GVHD occurs when transplanted immune cells recognize the 
recipient as foreign and mount an immune response, causing the disease. Acute GVHD 
occurs only in allogeneic transplants and usually affects the skin, gastrointestinal 
system, and liver; common manifestations include skin rash, watery diarrhea, persistent 
nausea, vomiting, cholestatic jaundice, and abnormal liver function tests. Systemic 
corticosteroids are the mainstay of therapy, and severe acute GVHD is associated with 
worse survival. During this early post-engraftment period, patients remain at risk of 
infectious complications. Despite neutropenia recovery, cellular immunity remains 
impaired, and there is a risk of opportunistic infections such as cytomegalovirus and 
susceptibility to common respiratory viruses like influenza and adenovirus. As a general 
rule, the presence of GVHD and its treatment entails a higher degree of 
immunosuppression. Therefore, patients with active GVHD have a higher risk of 
invasive fungal infections and viral reactivation. 
3. Late post-engraftment period: typically from day 100 onwards. Chronic GVHD can 
occur and affect one or more organs (skin is usually the most affected). If the salivary 
and lacrimal glands are affected, it results in increased dryness. As with acute GVHD, 
the gastrointestinal tract and liver can be affected. Patients with chronic GVHD 
experience autoimmune phenomena and more frequent opportunistic infections, 
reducing their quality of life. Multimodal treatment is often used, but management is 
usually based on immunosuppression. After HSCT, patients need to receive their 
primary immunizations again. Throughout the entire post-transplant period, the 
recurrence of the underlying disease remains one of the leading causes of mortality. 
Post-HSCT survivors, especially those with chronic GVHD, score lower on measures of 
quality of life (2). 
It is observed that bone marrow transplantation can be a curative option for high-risk cancer 
patients and other life-threatening diseases. Advances in transplantation have led to an 
increasing number of long-term survivors, estimated to reach 500,000 in the United States 
alone by 2030. As overall outcomes and survival after BMT improve, infections remain among 
the most important causes of late morbidity and mortality, accounting for 7% to 13% of deaths 
among survivors within 3 years. The entire team must maintain high vigilance for infections in 
this population and ensure adherence to existing antimicrobial prophylaxis and vaccination 
guidelines (6). 
1.2 Main Symptoms in Patients Undergoing HSCT 
The most common symptoms experienced by patients undergoing HSCT include both physical 
symptoms (fatigue, pain, sleep disturbances, nausea, loss of appetite, drowsiness) and 
psychological (anxiety, depression) and social symptoms (loneliness, negative self-image, loss 

of control and privacy). The most prevalent symptoms include pain (particularly musculoskeletal 
pain), fatigue, and sleep difficulties (7)(8)(9). These symptoms, along with the physical isolation 
of patients during hospitalization (an average of 3 to 4 weeks), can contribute to a decline in 
quality of life and mood (10). Joint Commission International, the American College of 
Physicians, the National Comprehensive Cancer Network (NCCN), and the American Society of 
Clinical Oncology (ASCO) recommend a combination of pharmacological and non-
pharmacological modalities in the management of pain, one of the most common, costly, and 
feared symptoms in cancer patients. Integrative Medicine therapies are non-pharmacological 
interventions, and evidence is growing regarding the use of mind-body practices (such as yoga, 
meditation, tai chi chuan, relaxation), acupuncture, massage therapy, and music therapy in 
managing pain for these patients (8). Although pain-related symptoms are not well-described in 
patients undergoing HSCT, evidence suggests that most of the pain in these patients is 
correlated with mucositis, GVHD, vascular necrosis, arthralgias, myalgias, and muscle cramps 
(9). If pain is exacerbated by anxiety, fear, depression, sleep disturbances, or psychological 
distress, mind-body therapies and therapeutic massage should be considered (8). It is noted 
that pain increases during hospitalization (11). Fatigue is characterized by a chronic and intense 
feeling of tiredness, which is not typically associated with stress and does not decrease with 
rest. On a physical level, fatigue manifests as bodily tiredness and lack of strength, on an 
emotional level as depressed motivation and mood, and on a cognitive level as difficulty 
concentrating (12). Fatigue is one of the most common concerns of HSCT survivors, affecting 
adult patients undergoing both allogeneic and autologous transplants to a high degree. The 
level of fatigue increases during hospitalization and usually remains with the highest post-
transplant scores compared to other symptoms, although it gradually decreases to pre-
transplant levels over time (9)(11)(13). Gielissen et al. demonstrated that 35% of transplant 
patients (both allogeneic and autologous) still had severe fatigue one year after the transplant 
(14). In most studies, factors associated with fatigue include younger age and chronic pain for 
all patients, and specifically, female sex and chronic GVHD in allogeneic recipients (15). Fatigue 
represents a high risk for the development of clinical depression and anxiety (12). 
Understanding of this issue is still limited in pediatric survivors (9). Loss of appetite, as well as 
nausea/vomiting, are symptoms with the highest increase before transplant and during 
hospitalization. They gradually and continuously decrease after discharge (11). Sleep-related 
problems also worsen during hospitalization, improve after discharge, but remain as a persistent 
symptom at a high level, although not surpassing the level of fatigue. Dyspnea should be 
considered a moderate but persistent problem, in which patients experience shortness of breath 
or difficulty breathing. Patients report lower levels of physical capacity during hospitalization, 
and scores usually improve to pre-transplant levels after one year. Fatigue, dyspnea, and 
insomnia are symptoms that persist and should therefore be considered persistent problems 
after HSCT, with scores above the general population (11). Physical recovery usually occurs 
earlier than emotional recovery in transplant patients (16). It is well-documented that being 
diagnosed and treated for cancer is a challenging experience, associated with high levels of 
stress and suffering. Stress remains high in 22% to 43% of long-term HSCT survivors, due to 
various factors such as difficulty living with uncertainties, fear of recurrence, anxiety and 
depression, loneliness, memory problems, financial concerns, and somatic worries (9)(17). Risk 
factors do not consistently vary by gender, age, or time since transplant, but stress appears to 
be higher for patients treated with prednisone, those with chronic GVHD, lower family income, 
greater physical limitations, higher level of education, or lower social support (9)(16)(17). 
Caregivers should be trained to provide better support and meet the needs of patients, as well 
as to learn how to better communicate their own needs. Ineffective and low-quality social 
support often increases the stress and suffering of the patient. Good communication between 
the multiprofessional team and caregivers/family members can improve the quality and quantity 
of support and meet the specific needs of each patient (17). With advances in reduced-intensity 
conditioning and supportive care in hematopoietic cell transplantation, few studies report 
clinically significant rates of Post-Traumatic Stress Disorder (PTSD) symptoms and associated 
risk factors (18). HSCT can be considered a traumatic event, defined according to the 
Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), as exposure to 
"death, threat of death, or actual serious injury" and can encompass "a sudden, catastrophic 

event" due to a medical occurrence. Thus, transplantation has the potential to lead to a 
diagnosis of PTSD in patients and their informal family caregivers. A broader approach is 
needed to screen for stress problems in cancer patients, taking into account the psychological 
history of the patients (18)(19). It is observed that PTSD affects 5% to 28% of these adult 
patients, but symptoms are likely underdiagnosed or diagnosed as depression or anxiety 
(9)(18). Interestingly, the number of studies reporting positive psychological benefits from 
cancer diagnosis and treatment has been increasing (20). In HSCT survivors, few studies have 
examined Post-Traumatic Growth (PTG): positive psychological change experienced as a result 
of exposure to traumatic or highly challenging events, and even fewer have considered 
evaluations of spirituality in this population (9). PTG is associated with a greater appreciation of 
life, better relationships, existential growth, increased self-confidence, and self-esteem. Possible 
mediators of PTG include social support, proactive guidance from the healthcare team, support 
groups, expressive writing, cognitive-behavioral therapy, and meditation, among others, which 
can serve as methods to enhance PTG (9)(21). In a recent study (2021) conducted by Maya 
Corman et al. that analyzed PTG five months after HSCT, they reported that the experience of 
this treatment seems to be more related to psychological decline after transplantation than to 
PTG (22). 
This comprehensive review provides valuable insights into the challenges and symptoms faced 
by patients undergoing Hematopoietic Stem Cell Transplantation (HSCT). It highlights the 
multifaceted nature of the physical, psychological, and social issues encountered during this 
complex medical procedure. Understanding these challenges is crucial for healthcare providers 
to improve the care and quality of life for HSCT recipients. Additionally, the discussion of 
potential complementary therapies, such as yoga and mind-body practices, underscores the 
importance of holistic approaches to managing the symptoms and improving the overall well-
being of these patients. 
 
2. OBJECTIVE 
This project aims to analyze the impact of yoga and gentle massage practices on symptom 
management in patients undergoing Bone Marrow Transplantation. 
2.1 Primary Objective 
 
To analyze the effects of yoga and/or gentle massage practices + standard treatment 
versus standard treatment alone on symptom management in patients undergoing 
Hematopoietic Stem Cell Transplantation, assessed by the Edmonton Symptom 
Assessment Scale (ESAS). Primary Outcomes 
 
To analyze changes in ESAS in the domains of fatigue, pain, nausea, anxiety, and well-
being before and after each of the 8 sessions. 
2.2 Secondary Objectives 
 
To analyze changes in the Quality of Life Scale during HSCT; 
 
To analyze changes in the Religiosity Scale during HSCT; 
 
To analyze the subjective experience of the patient during HSCT; 
 
To analyze patient satisfaction during HSCT. Secondary Outcomes 
 
Changes in the Quality of Life Scale at 2 time points: upon admission and on 
Day 21 or at discharge (whichever occurs first); 
 
Changes in the Religiosity Scale at 2 time points: upon admission and on Day 
21 or at discharge (whichever occurs first); 

 
Open-ended question about the subjective experiences of patients undergoing 
HSCT on Day 21 or at discharge (whichever occurs first); 
 
Questions about patient satisfaction during HSCT on Day 21 or at discharge (whichever 
occurs first). 
2.3 Hypothesis The practice of yoga and gentle massage combined with standard treatment is 
superior to standard treatment alone in symptom management in patients undergoing HSCT. 
3. METHOD  
3.1 Population The study will be conducted at the Albert Einstein Israelite Hospital - Morumbi 
Unit, with patients admitted to the Oncology and Hematology Center for Bone Marrow 
Transplantation. Only after obtaining Informed Consent (ICF) acceptance, the patient's clinical 
and sociodemographic variables during hospitalization will be extracted from the electronic 
medical record of the institutional database: age, gender, month/year and type of transplant, 
conditioning intensity, donor type, cell source, and underlying disease. 
3.1.1 Inclusion Criteria 
 
Adults aged 18 and older; 
 
Admitted to the HIAE, eligible for Bone Marrow Transplantation; 
 
Patients who speak and read Portuguese. 
3.1.2 Exclusion Criteria 
 
Patients with hearing impairment; 
 
Patients previously diagnosed with psychiatric disorders: schizophrenia. 
3.2 Experimental Design This is a prospective open-label randomized study evaluating the 
practice of yoga and gentle massage combined with standard treatment versus the use of 
standard treatment alone. 
3.3 Sample Size The sample will consist of a total of 40 patients for this study. Based on a pilot 
sample (N = 40) with only one session of yoga + gentle massage, an improvement of 1.58 
points (SD = 1.58 points) in fatigue was observed. Aiming to find an average difference of at 
least 1.5 points between the intervention group (yoga + gentle massage + standard treatment) 
and the control group (exclusive standard treatment) over 8 proposed sessions, with 80% power 
and 95% confidence, a sample of 18 patients in each group would be required. Since, in 
addition to fatigue, other parameters such as pain, nausea, anxiety, and well-being will be 
evaluated, we will use a sample of at least 20 patients per group to also account for these 
parameters, totaling at least 40 patients in the study. 
3.4 Randomization Randomization will be performed according to the randomization block 
generated by Excel and will be carried out using the REDCap tool. Thus, upon accepting 
participation in the protocol, each patient will receive an individual number that will be included 
in this randomization block, with the sequence of their participation in the protocol 
predetermined by the Excel table to be inserted into REDCap and randomized according to 
parameterization, stratified by age groups: 18 to 30 / 31 to 50 / 51 to 65 / over 66 years 18 to 40 
/ 41 to 60 / above 61 years and by type of transplant: autologous, allogeneic, and umbilical cord. 
3.5 Training Program During the HSCT period, patients will be randomized into two groups: 
 
Group A (control): standard treatment 
 
Group B (intervention): yoga  or gentle massage plus standard treatment 
The intervention sessions will be verbally conducted by integrative therapists from the 
Integrative Medicine Team, hired by the Oncology and Hematology Center of HIAE, all with 

postgraduate degrees in Yoga (Institute of Teaching and Research in Yoga - IEPY) and in 
Integrative Health Bases and Well-being (Albert Einstein Institute of Teaching and Research - 
IIEP). Group B (intervention) will receive a total of 8 individual integrative practice sessions at 
the bedside, each lasting 15 to 20 minutes, with 2 sessions per week during the following 
periods: • from admission until Day 0 • until Day 7 • until Day 14 • until Day 21 or discharge. The 
therapist will choose the integrative practices that best suit the patient for each session, 
according to their psychophysical state and presented symptoms, as there are many variations 
during HSCT. Group A (control) will receive 8 visits from integrative therapists who will remain in 
the patient's room, able to interact but without offering integrative practices, during the same 
period described above. After Day 21, these patients will also receive 8 integrative practice 
sessions at the bedside or in the Integrative Medicine room. If any patient from this group needs 
to receive Integrative Medicine care, they will receive it and be withdrawn from the study.  
3.5.1 Yoga Yoga sessions will be conducted at the patient's bedside, in a supine or sitting 
position, using one or more of the following techniques: gentle stretches (asanas), guided 
relaxation (savasana), deep and slow diaphragmatic breathing (pranayama), and meditative 
exercises focusing on natural breathing or visualizing a place that brings well-being (dhyana). 
Based on these techniques, the integrative therapist will choose what best suits the patient for 
each session, according to their psychophysical state and presented symptoms, as there are 
many variations during HSCT. Non-violence (ahimsa) as a basic and essential principle of yoga 
practice will be reiterated in each class to encourage participants to be gentle with themselves 
and accept possible limitations. 
3.5.2 Massage Gentle massage involves gentle touches, using light pressure, mainly with the 
palm, with a slow and steady rhythm over the entire body. It can be performed over clothing and 
even over the sheet and blanket. The sequence of light touches begins at the head, moving 
down the right shoulder, arm, forearm, and right hand; thigh, knee, leg down to the right foot, 
where it will be gently massaged on the back, fingers, and sole of the right foot. Afterward, the 
therapist's hands move up in the reverse sequence on the left side of the patient's body, 
finishing again at the head. The action of this technique is on the skin and not on the muscles. 
Sensory information from this gentle touch on the epidermis activates the Relaxation Response 
in the Autonomic Nervous System, increasing the stimulation of the PNS and decreasing the 
excitement of the SNS. 
3.6 Assessments The scales and questionnaires will be digitally administered through the 
REDCap Einstein platform. Only the Qualitative Report will be provided in printed form for the 
patient to describe their experience. All these documents are available in the appendices of this 
project. 
3.6.1 Edmonton Symptom Assessment Scale - ESAS-Br The Edmonton Symptom 
Assessment Scale - ESAS-Br will be used before and after each of the 8 sessions in both 
groups, assessing the domains: pain, fatigue, nausea, anxiety, and well-being. 
3.6.2 Functional Assessment Cancer Therapy - Bone Marrow Transplantation Quality of 
Life Scale - FACIT-BMT The Functional Assessment Cancer Therapy - Bone Marrow 
Transplantation Quality of Life Scale - FACIT-BMT will be used at two time points: upon 
admission and on Day 21 (or at discharge). 
3.6.3 Duke Religious Index - DUREL The Duke Religious Index - DUREL will be applied at two 
time points: upon admission and on Day 21 (or at discharge). 
3.6.4 Qualitative Report The Qualitative Report will be handed to the patient in printed form on 
Day 21 (or at discharge), using an open-ended question for the patient to describe: "What was 
your experience with Integrative Medicine like?" 
3.6.5 Patient-Reported Experience Measures (PREMs) To assess patient satisfaction and 
experience, the Patient-Reported Experience Measures (PREMs) will be applied on Day 21 (or 
at discharge). 

3.7 Statistical Analysis The qualitative characteristics of patients will be described according to 
groups using absolute and relative frequencies, and associations with the groups will be verified 
using chi-square tests or exact tests, while quantitative characteristics will be described 
according to groups using summary measures (mean, standard deviation, median, minimum, 
and maximum), and group comparisons will be made using t-Student tests or Mann-Whitney 
tests depending on the probability distribution of the data. Mean changes in each ESAS domain 
over the 8 therapy sessions will be calculated, and group means on the scales will be compared 
using t-Student tests or Mann-Whitney tests. The analyses will be performed using IBM-SPSS 
software for Windows version 22.0, tabulated using Microsoft-Excel 2010 software, and tests 
will be conducted at a 5% significance level. 
4. ETHICAL ASPECTS This project will be submitted for review to the Research Project 
Management System of the Albert Einstein Israelite Hospital (HIAE), the institution hosting the 
Einstein Family Dayan - Daycoval Oncology and Hematology Center. Subsequently, it will be 
submitted to the Brazil Platform and the institutional Research Ethics Committee. All patients will 
sign the Informed Consent Form because it involves human subjects. 
5. RISKS AND BENEFITS 
5.1 Risks The expected risks, if any, for the procedures of this study (yoga and gentle 
massage) and for responses to research questions are minimal. Given that the topic of 
integrative practices would not put subjects at risk of health, criminal or civil liability, or be 
detrimental to their financial situation, employability, educational advancement, or reputation. 
Although we consider the risks of participation in this study to be low, we will ensure that any 
situation is handled sensitively and empathetically. If any discomfort arises during the study, it 
may be discontinued. 
5.2 Benefits As this is a randomized study, participants may not directly benefit from the 
proposed research; however, others may benefit from the knowledge gained in this study. 
 
 
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