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Completed

NCT Number: NCT02696408

Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation

The LLLT has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated lesions. There are little data in the literature showing its efficacy in prevention of mucositis in cohorts of patients with hematopoietic stem cells transplantation.

The main objective of this study is to assess the efficacy of a prophylactic low level laser therapy performed by nurses on the severity of oral mucositis during HSCT.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Léon Bérard, Lyon, France

Loading trial locations.

About this study

The main end point for efficacy is the reduction of severe mucositis (grade 3 or more). The secondary efficacy endpoints are the reduction of mucositis, whatever the grade, the reduction of time with mucositis, the time to onset of mucositis symptoms, the reduction of pain intensity and evaluation of quality of life.The secondary endpoints for safety are severe adverse events and potential toxicity. Patients will be allocated at inclusion with a 1/1 ratio either to laser-on or laser-off groups. In the laser group, patients will undergo laser therapy performed by nurses, which will consist of irradiation of the whole oral cavity during 2 minutes with 250mW power. In the laser-off group, laser therapy will be carried out with equipment off during the same time, and still performed by nurses. Protective eye shields will be used to avoid detrimental effects on eyes and to keep the subjects blind.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient undergoing autologous or allogeneic HSC (Hematopoietic Stem Cell) transplantation with myeloablative conditioning
  • Patient affiliated to a social security
  • Signed inform consent

Exclusion criteria

  • Patient undergoing HSCT (Hematopoietic Stem Cell Transplantation) with reduced intensity conditioning Slavin (FB2) or Seattle (F-2 Gy TBI)
  • Protected major patient
  • Pregnant woman
  • Patient with pacemaker
  • Epileptic Patient

Treatment and study plan

Laser treatment

Device

Patients randomized to the experimental arm receive in addition to mouthwash, preventive treatment of mucositis by LLLT performed by nurses consisting of daily scanning the entire oral cavity for 2 minutes with a power of 250 mW, starting with conditioning and ongoing until the onset of mucositis of grade 1.

If the mucositis is localised, preventive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), preventive laser is stopped for curative laser only.

Other names: Oncolase DIGI D5W200

PLACEBO

Device

Patients randomized to the Placebo arm receive in addition to mouthwash fictive laser treatment performed by nurses until the onset of mucositis of grade 1.

If the mucositis is localised, fictive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), fictive laser is stopped for curative laser only.

Primary outcomes

  1. prevalence of grade 3 mucositis and more

    Time frame: 30 days

    prevalence of grade 3 and more mucositis following the classification proposed by WHO (world health organization)

Secondary outcomes

  1. number of all grades of mucositis

    Time frame: 30 days

    The number of all grades of mucositis will be reported at day 30 post graft for all patients.

  2. duration of mucositis

    Time frame: 30 days

    The duration of mucositis will be reported at day 30 post graft for all patients.

  3. time of onset of mucositis

    Time frame: 30 days

    time of onset of mucositis will be assessed by measuring the interval between the beginning of packaging and the first day of mucositis has been assessed at a grade 1

  4. Pain

    Time frame: 30 days

    Pain will be reported for each patient during their participation: 30 days post graft maximum.

  5. Quality of life

    Time frame: 30 days

    Quality of life will be reported for each patient during their participation: 30 days post graft maximum.

  6. Safety

    Time frame: 30 days

    serious adverse events will be reported for each patient during their participation: 30 days post graft maximum.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de la Loire

Other

Collaborators

  • Centre Leon Berard
  • Hospices Civils de Lyon
  • Société Biophoton

Registry information

Official study title

Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation : a Randomized Double Blind Multicenter Prospective Phase III Trial

Acronym: STOP MUCITES

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2016
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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