Hematologic Cancer
Conditions
Keywords
Low level laser therapy, Hematopoietic stem cell transplantation, Oral mucositis, Physical fitness, Physical therapy
Brief summary
The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT). The main questions it aims to answer are: • Is photobiomodulation with laser in the oral cavity, compared to standard care, effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT? • What is the level of patient´s acceptability of photobiomodulation with laser in the oral cavity during HSCT? Participants once a day will receive photobiomodulation (diode laser device) in their oral cavity from the first day of transplantation conditioning until third day post-transplant. Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment.
Detailed description
Background: Oral mucositis is a highly prevalent condition in individuals treated for hematologic neoplasms, primarily during hematopoietic stem cell transplantation (HSCT). This condition delays the recovery process, increasing infections, interventions, and hospital stays. To date, there are few experimental trials evaluating the use of photobiomodulation with laser for the management of oral mucositis and reporting its effect on functional outcomes in patients with hematologic cancer undergoing HSCT. Aim: To evaluate the effectiveness and social acceptability of using photobiomodulation in the oral cavity to prevent mucositis and functional impairments in adult patients undergoing HSCT. Methods: Randomized controlled clinical trial with parallel groups (intervention group with photobiomodulation versus a control group), assessor and statistician blinded. Participants and setting: 30 patients with hematologic neoplasms aged 18 to 65 undergoing HSCT at the Oncology and Bone Marrow Transplant Unit of Clínica Dávila. Primary outcome measures: Oral mucositis will be assessed on a daily basis with the World Health Organization Scale. Functional capacity will be evaluated with a 2-minute static walking test; handgrip strength using digital Jamar® dynamometry; lower limb strength with 30s Sits-and-Stand test; and quality of life using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire. Acceptability will be assessed by recording treatment adherence and a Visual Analog Scale. Evaluations will be performed at two time points: on admission to the transplant unit before the start of the conditioning regimen and on the day of hospital discharge. Intervention: Photobiomodulation will be delivered from the first day of conditioning until day 3 post-transplant. A diode laser device with a wavelength of 660 nm, an output power of 40 mW, and an energy density of 4 J/cm2 measured at the end of the optical fiber with 0.04 cm2 of sectional area will be used. The investigators expect that photobiomodulation prevents oral mucositis and enhance functional capacity, muscle strength, nutritional status, and quality of life in patients with hematologic cancer undergoing bone marrow transplantation.
Interventions
DEVICEPhotobiomodulation
Photobiomodulation will be used in sessions of approximately 5 to 10 minutes each. An InGaIP diode laser will be used with the following parameters: wavelength of 660 nm, output power of 40 mW, and an energy density of 4 J/cm2 measured at the end of the fiber optic with 0.04 cm2 of section area. The laser will be applied at 10 points in each oral region, with an exposure time of 4 s per point, using 0.16 J of energy per point. The protocol was based on previous studies.
OTHERUsual care
Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Sponsors
Agencia Nacional de Investigación y Desarrollo
Clínica Dávila
Universidad del Desarrollo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Assessor will be blinded only for the secondary outcomes. The person responsible for statistical analyses will also be blinded.
Intervention model description
The design of the study consists of a randomized, controlled trial with parallel groups (photobiomodulation + usual care versus a control group with only usual care), allocation ratio of 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults over 18 years of age with hematological neoplasms who require medical indication of an HSCT according to the Transplant Committee at Clinica Dávila * With sufficient understanding of Spanish.
Exclusion criteria
* Observed cognitive deficit * Patients who do not meet the criteria of clinical stability, progression of the disease, and that do not fulfill requirement of the National Hematopoietic Stem Cell Transplantation Program. * Participants with an oral infection from any type of Candida prior to HSCT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Mucositis | From the first day up to the 20th after stem cell transplantation (or up to the day of hospital discharge if prior to day 20) | It refers to the maximal degree of oral mucositis developed after stem cell transplantation. It will be recorded daily from the first day after stem cell transplantation up to the day 20 after transplantation). The World Health Organization (WHO) oral mucositis scale will be used. Scores range from 0 (no mucositis), 1 (pain/erythema), 2 (erythema, ulcers; can eat solid foods), 3 (ulceration, requiring only a liquid diet), to 4 (oral feeding is not possible). The higher the grade, the worse the mucositis. |
| Level of Pain | From the first day up to the 20th day after stem cell transplantation (or up to the day of hospital discharge if prior to day 20) | It refers to the perceived level of pain related to oral mucositis from a numeric scale (0 to 10), where 0 means no pain and 10 the worse possible pain. Higher scores means more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical fitness | Through study completion on the day of hospital discharge, an average of 1 month | It is the ability to carry out daily tasks and perform physical activities in a highly functional state, often as a result of physical conditioning. Physical fitness will be evaluated with the 30-Second Sit and Stand (SST30') assesses the ability to rise from a chair and sit back down, as well as the strength and functionality of the lower limbs. |
| Health related quality of life | Through study completion on the day of hospital discharge, an average of 1 month | Health related quality of life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. Quality of life will be assessed using the validated and widely used instrument in the oncology population undergoing hematopoietic stem cell transplantation, the Functional Assessment of Cancer Therapy-Bone Marrow Transplant questionnaire. |
| Length of hospital stay | Through study completion on the day of hospital discharge, an average of 1 month | Number of hospitalization days/bed days from the day of admission to medical discharge |
| Use of opioids | Through study completion on the day of hospital discharge, an average of 1 month | The number of days that the patient required analgesic medication (opioids) and receives it to alleviate oral mucositis pain from the onset of oral mucositis according to World Health Organization criteria until medical discharge. |
| Body mass index | Through study completion on the day of hospital discharge, an average of 1 month | The body mass index is a person's weight in kilograms divided by the square of height in meters. It will be obtained from the patient's clinical file. Higher values mean malnutrition due to body weight excess and lower values mean malnutrition due to underweight. It will be classified according to World Health Organization: underweight (\<18.5), normal weight (18,5 to 24.9), overweight (25 to 29.9) and obesity (\>30). |
| Handgrip strength | Through study completion on the day of hospital discharge, an average of 1 month | It is the maximal isometric strength of the handgrip that will be measured in KgF with Hydraulic Hand Dynamometer (Jamar Digital Plus®). |
| Daily calorie intake | Through study completion on the day of hospital discharge, an average of 1 month | It correspond to the mean of daily calorie intake (kcal/day) of the patient. It will be obtained from the hospital record. Higher values mean higher calorie intake. |
| Arm circumference | Through study completion on the day of hospital discharge, an average of 1 month | It is the circumference of the arm (cm) that will be measured in the mean point between the distance of olecranon and acromion with relaxed arm and elbow flexed at 90 degrees. |
| Triceps skinfold | Through study completion on the day of hospital discharge, an average of 1 month | Corresponds to the thickness of the triceps region (mm). It will be assessed with a skinfold caliper. Higher values indicate more body fat. |
| Acceptability | Through study completion on the day of hospital discharge, an average of 1 month | To estimate patient´s acceptability, a visual analogue scale from 0 to 10 will be used only with intervention group, where 0 refers to no acceptability, 5 to a moderate level of acceptability and 10 to an optimal level of acceptability. Furthermore, the register of adherence to the PBM sessions will serve as an indicator of this acceptability, since the professional who performs the intervention will consult the patient every day regarding their willingness to receive PBM and will note on the record sheet. |
| Number of days from transplant to engraftment | Through study completion on the day of hospital discharge, an average of 1 month | It to refers to how long, in days, did it take to engrafment of the hematopoyetic stem cell transplant. Engraftment is the process by which hematopoietic stem cells (HSC) make their way (homing) to free bone marrow (BM) niches where they can find optimal conditions to survive and proliferate. |
| Nutritional status | Through study completion on the day of hospital discharge, an average of 1 month | Nutritional status has been defined as an individual's health condition as it is influenced by the intake and utilization of nutrients. The evaluation of the nutritional status will be through the Subjective Global Evaluation. This scale classifies patients in: well nourished, mildly/moderately malnourished, or severely malnourished. |
| Exercise tolerance | Through study completion on the day of hospital discharge, an average of 1 month | The exercise capacity of an individual as measured by endurance (maximal exercise duration and/or maximal attained work load) during an EXERCISE TEST. It will be assessed with the 2-Minute Walking Test is a functional test that assesses an individual's aerobic capacity and is used as a performance measure. |
Countries
Chile
Contacts
Primary ContactCinara Sacomori, Ph.D.
Backup ContactTomás Lopez, MScC.
Outcome results
None listed