Hematologic CancerPOMFITTNCT06260111
Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation
A study testing Photobiomodulation in people with Hematologic Cancer, run by Universidad del Desarrollo at 1 site in Chile.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Cancer
- What is being tested?
- Photobiomodulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 10 Jun 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Clinica Dávila
Santiago, Santiago Metropolitan, 8431657
Tomás A López-Espinoza, MSc.C., +56962056755, tlopeze@udd.cl
Hernán López, MD, +56966795985, hernan.lopez@davila.cl
About this study
Official title: Laser Photobiomodulation to Prevent Oral Mucositis and Functional Impairment Among Adult Hematologic Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Hematologic Cancer
- Being tested
- Photobiomodulation, Usual care
- Keywords
- Low level laser therapy, Hematopoietic stem cell transplantation, Oral mucositis, Physical fitness, Physical therapy
- Medical subject headings
- Hematologic Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Also called Low level laser therapy
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.
Usual careOther
Usual care for oral mucositis includes education, cryotherapy, and mouth hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Experimental | Photobiomodulation and usual care (education, cryotherapy, and mouth hygiene). Receives: Device: Photobiomodulation; Other: Usual care |
| Control group | Other | Usual care (education, cryotherapy, and mouth hygiene). Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Secondary outcomes (13)
Handgrip strength
It is the maximal isometric strength of the handgrip that will be measured in KgF with Hydraulic Hand Dynamometer (Jamar Digital Plus®).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion on the day of hospital discharge, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start10 Jun 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo, Clínica Dávila
- Responsible party
- Principal investigator, Cinara Sacomori, Ph.D., Universidad del Desarrollo
- Investigators
- Cinara Sacomori, Ph.D., Principal investigator, Universidad del DesarrolloPaulina A Araya-Castro, Ph.D., Study chair, Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260111
- Sponsor's protocol ID
- SA23I0021
- Acronym
- POMFITT
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ferreira B, da Motta Silveira FM, de Orange FA. Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial. Support Care Cancer. 2016 Mar;24(3):1035-42. doi: 10.1007/s00520-015-2881-8. Epub 2015 Aug 7.
PubMed 26248655Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
PubMed 32786044Robijns J, Nair RG, Lodewijckx J, Arany P, Barasch A, Bjordal JM, Bossi P, Chilles A, Corby PM, Epstein JB, Elad S, Fekrazad R, Fregnani ER, Genot MT, Ibarra AMC, Hamblin MR, Heiskanen V, Hu K, Klastersky J, Lalla R, Latifian S, Maiya A, Mebis J, Migliorati CA, Milstein DMJ, Murphy B, Raber-Durlacher JE, Roseboom HJ, Sonis S, Treister N, Zadik Y, Bensadoun RJ. Photobiomodulation therapy in management of cancer therapy-induced side effects: WALT position paper 2022. Front Oncol. 2022 Aug 30;12:927685. doi: 10.3389/fonc.2022.927685. eCollection 2022.
PubMed 36110957Tribolet P, Kaegi-Braun N, Gressies C, Baumgartner A, Wagner KH, Stanga Z, Schuetz P. Handgrip Strength Values Depend on Tumor Entity and Predict 180-Day Mortality in Malnourished Cancer Patients. Nutrients. 2022 May 23;14(10):2173. doi: 10.3390/nu14102173.
PubMed 35631314Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164.
PubMed 29210933McQuellon RP, Russell GB, Cella DF, Craven BL, Brady M, Bonomi A, Hurd DD. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997 Feb;19(4):357-68. doi: 10.1038/sj.bmt.1700672.
PubMed 9051246Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
PubMed 22613940Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
PubMed 10380242Lopez-Espinoza T, Araya-Castro P, Gutierrez-Silva L, Pena-Espinoza M, Sacomori C. Photobiomodulation to prevent oral mucositis and physical function impairments after hematopoietic cell transplantation: POMFITT randomized trial. Support Care Cancer. 2026 Jul 3;34(7):732. doi: 10.1007/s00520-026-10970-x.
PubMed 42399564Lopez-Espinoza T, Sacomori C, Araya-Castro P, Quintiliano-Scarpelli D, Roldan P, Pena-Espinoza M, de Rezende LF, Lopez-Vidal H. Photobiomodulation therapy to prevent oral mucositis and functional impairment in adult patients with haematological cancer undergoing haematopoietic stem cell transplantation: randomised trial protocol. BMJ Open. 2024 Oct 26;14(10):e088073. doi: 10.1136/bmjopen-2024-088073.
PubMed 39461860
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Photobiomodulation to Prevent Oral Mucositis and Functional Impairment Among Adult Hematologic Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06260111
- Acronym / sponsor ID
- POMFITT / SA23I0021
- Conditions
- Hematologic Cancer
- Keywords
- Low level laser therapy, Hematopoietic stem cell transplantation, Oral mucositis, Physical fitness, Physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo, Clínica Dávila
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Experimental | Device: Photobiomodulation, Other: Usual carePhotobiomodulation and usual care (education, cryotherapy, and mouth hygiene). |
| Control group | Other | Other: Usual careUsual care (education, cryotherapy, and mouth hygiene). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAlso: Low level laser therapyPhotobiomodulation 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. | Device | Photobiomodulation group |
| Usual careUsual care for oral mucositis includes education, cryotherapy, and mouth hygiene. | Other | Control group, Photobiomodulation group |
Primary outcome
Oral 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)
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
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)
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.
13 secondary outcomes
Handgrip strength
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Exercise tolerance
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Physical fitness
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Health related quality of life
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Length of hospital stay
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Use of opioids
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Body mass index
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Nutritional status
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Daily calorie intake
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Arm circumference
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Triceps skinfold
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Acceptability
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Number of days from transplant to engraftment
Time frame: Through study completion on the day of hospital discharge, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 26248655Ferreira B, da Motta Silveira FM, de Orange FA. Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial. Support Care Cancer. 2016 Mar;24(3):1035-42. doi: 10.1007/s00520-015-2881-8. Epub 2015 Aug 7.
- Background: PubMed 32786044Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
- Background: PubMed 36110957Robijns J, Nair RG, Lodewijckx J, Arany P, Barasch A, Bjordal JM, Bossi P, Chilles A, Corby PM, Epstein JB, Elad S, Fekrazad R, Fregnani ER, Genot MT, Ibarra AMC, Hamblin MR, Heiskanen V, Hu K, Klastersky J, Lalla R, Latifian S, Maiya A, Mebis J, Migliorati CA, Milstein DMJ, Murphy B, Raber-Durlacher JE, Roseboom HJ, Sonis S, Treister N, Zadik Y, Bensadoun RJ. Photobiomodulation therapy in management of cancer therapy-induced side effects: WALT position paper 2022. Front Oncol. 2022 Aug 30;12:927685. doi: 10.3389/fonc.2022.927685. eCollection 2022.
- Background: PubMed 35631314Tribolet P, Kaegi-Braun N, Gressies C, Baumgartner A, Wagner KH, Stanga Z, Schuetz P. Handgrip Strength Values Depend on Tumor Entity and Predict 180-Day Mortality in Malnourished Cancer Patients. Nutrients. 2022 May 23;14(10):2173. doi: 10.3390/nu14102173.
- Background: PubMed 29210933Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164.
- Background: PubMed 9051246McQuellon RP, Russell GB, Cella DF, Craven BL, Brady M, Bonomi A, Hurd DD. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997 Feb;19(4):357-68. doi: 10.1038/sj.bmt.1700672.
- Background: PubMed 22613940Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
- Background: PubMed 10380242Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
- Derived from this study: PubMed 42399564Lopez-Espinoza T, Araya-Castro P, Gutierrez-Silva L, Pena-Espinoza M, Sacomori C. Photobiomodulation to prevent oral mucositis and physical function impairments after hematopoietic cell transplantation: POMFITT randomized trial. Support Care Cancer. 2026 Jul 3;34(7):732. doi: 10.1007/s00520-026-10970-x.
- Derived from this study: PubMed 39461860Lopez-Espinoza T, Sacomori C, Araya-Castro P, Quintiliano-Scarpelli D, Roldan P, Pena-Espinoza M, de Rezende LF, Lopez-Vidal H. Photobiomodulation therapy to prevent oral mucositis and functional impairment in adult patients with haematological cancer undergoing haematopoietic stem cell transplantation: randomised trial protocol. BMJ Open. 2024 Oct 26;14(10):e088073. doi: 10.1136/bmjopen-2024-088073.
- Definition of outcomesLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cinara Sacomori, Ph.D. principal investigator
Universidad del Desarrollo
Paulina A Araya-Castro, Ph.D. study chair
Universidad del Desarrollo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Hematologic Cancer, run by Universidad del Desarrollo at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cinara Sacomori, Ph.D. (+562 23279661, csacomori@udd.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260111, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.