An interventional study of Photobiomodulation and Usual care in Hematologic Cancer, sponsored by Universidad del Desarrollo. Recruiting at 1 site in Chile. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Universidad del Desarrollo · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Photobiomodulation and usual care (education, cryotherapy, and mouth hygiene).
Device: Photobiomodulation · Other: Usual care
Usual care (education, cryotherapy, and mouth hygiene).
Other: Usual care
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.
Also known as: Low level laser therapy
Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
Oral Mucositis
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.
Time frame: 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)
Level of Pain
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.
Time frame: 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)
Handgrip strength
It is the maximal isometric strength of the handgrip that will be measured in KgF with Hydraulic Hand Dynamometer (Jamar Digital Plus®).
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Exercise tolerance
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Physical fitness
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Health related quality of life
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Length of hospital stay
Number of hospitalization days/bed days from the day of admission to medical discharge
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Use of opioids
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Body mass index
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).
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Nutritional status
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Daily calorie intake
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Arm circumference
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Triceps skinfold
Corresponds to the thickness of the triceps region (mm). It will be assessed with a skinfold caliper. Higher values indicate more body fat.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Acceptability
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Number of days from transplant to engraftment
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.
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Plan to share: Yes — Individual participant data may be requested to the researchers by e-mail, in case of relevant justification. All data shared with other researchers will be anonymous.
Supporting information: Study protocol, Sap
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