Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Herbal and Botanical

Turmeric extract

Curcumin

Mitogens

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Turmeric

Curcuma longa oral gel for prevention radiation induced oral mucositis

Curcumin Gel

Standard preparation for prevention radiation induced oral mucositis

Standard Preparation

The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.

Researchers will compare between curcumin group and standard treatment group.

Two groups A) curcuma longa oral gel group B) standard treatment group

Curcumin Gel On Radiation Induced Oral Mucositis

The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients

Onset (at which week) of radiation induced mucositis in relation to EGF and IL8

Change in severity (degree of illness) of radiation induced mucositis in relation to EGF \& IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}

University of Baghdad

principal investigator

Behaviors and Mental Disorders

Rare Diseases

Anxiety Disorders

Mouth Neoplasms

Oral Cancer

Lip and Oral Cavity Cancer

Central Nervous System Depressants

Adjuvants, Anesthesia

Psychotropic Drugs

Anesthetics

Fentanyl

Rocuronium

Midazolam

Propofol

Participants received music therapy intervention

Patients in control group receive premedication

Participants did not receive premedication with midazolam 0,02 mg/kg intravenous and received music therapy intervention by a certified music therapist FAMI . Music Treatment consisted of 3 steps:

(1)30 minutes before surgery, music therapist (MTp) engaged the patient in an individual brief conversation (10 min.) to identify preferred musical genre/songs and prepared a customized playlists to listen to during induction; (2)After being monitored in the operating room, patients were prepared to listening to music ; (3)Music listening during anesthesia induction. Anesthesia was the same in both groups. Induction was carried out by fentanyl 3mcg/kg, propofol 2 mg/kg and rocuronium at the dose of 1mg/kg to facilitate intubation

music therapy intervention

Partecipants receive premedication with midazolam 0,02 mg/kg intravenous. Anesthesia was the same in both groups. Induction was carried out by fentanyl 3mcg/kg, propofol 2 mg/kg and rocuronium at the dose of 1mg/kg to facilitate intubation

Filomena Puntillo, PhD

People undergoing general anesthesia for oral cancer diagnosis and treatment often experience heightened anxiety, fear and stress with negative bodily responses, such as tachycardia, hypertension, increased myocardial consumption of O2, arrhythmias, increased peripheral resistance, hypercoagulability, immunodeficiency and catabolic response . Emotional distress and pain may be managed by pre-procedurally application of anxiolytic, analgesic, and anesthetic drugs, but with potential risks or side effects such as respiratory depression, nausea and vomiting, confusion, memory loss, hypoxemia, and drug-drug interactions. This may result in adverse outcomes, such as delayed healing, increased healthcare utilization, and cost.

A recent Cochrane review showed that benzodiazepines reduce pre-procedural anxiety compared with placebo with a low quality of evidence.

Music therapy (MT), defined as the clinical and evidence-based use of music interventions by a trained professional for the purpose of achieving individualized goals within a therapeutic relationship between patient, music and music therapist 6 , may be used as a safe and cost-effective complementary intervention in adjunct to standard surgical care.

During surgery, music is a powerful positive stimulus that evokes and modulates emotions as well as mood, face mask adverse stimuli, and improves emotional health through coping.

Music therapy and music medicine interventions are effective to prevent and treat emotional distress and pain before, during and after medical procedures .

Evidence from Cochrane systematic reviews shows that music interventions affect positively anxiety in patients with cancer, coronary heart diseases and in patients on mechanical ventilation .

Some studies reported also that music interventions reduced sedative requirements in patients undergoing surgery under regional anesthesia combined with sedation, both with midazolam and propofol and also in critically ill patients in intensive care units.

The primary aim of this study was to evaluate the effects of preoperative music therapy intervention compared to premedication with midazolam on anxiety, sedation and stress during general anesthesia for odontostomatological elective surgery.

Preoperative Music Listening in Odontostomatological Surgery (PMLOS)

Preoperative Music Listening Versus Intravenous Midazolam (PMLOS) on Anxiety, Sedation and Stress in Odontostomatological Surgery: a Randomized Controlled Study

Anxiety Visual Analogues Scale (A-VAS) was used to evaluate the level of anxiety from 0 (no anxiety) to 10 (maximum anxiety) before surgical procedure T0

Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia. BIS monitors are used to supplement Guedel's classification system for determining depth of anesthesia. Titrating anesthetic agents to a specific bispectral index during general anesthesia in adults (and children over 1 year old) allows the anesthetist to adjust the amount of anesthetic agent to the needs of the patient, possibly resulting in a more rapid emergence from anesthesia.

BIS monitoring is widely used in clinical anesthesia as an index for monitoring the electrical activity of the cerebral cortex and the sedative ingredients of anesthesia. BIS scores range from 0 to 100 (0, coma; 40-60, general anesthesia; 60-90, sedated; 100, awake) and reflect the level of sedation regardless of a patient's clinical characteristics or the type of sedative drug used.

Patient global impression of satisfaction (PGIS) with a 4 items score ( 1=very dissatisfied, 2=dissatisfied, 3=satisfied, 4=very satisfied).

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Pain, Postoperative

Pain

Ganglion Cysts

Synovial Cyst

Cysts

Facies

Facial Pain

Postoperative Complications

Neurologic Manifestations

Mucinoses

Connective Tissue Diseases

Levobupivacaine

Mepivacaine

Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine)

Troncular scalp blockade (Levobupivacaine 7,5%) Local site infiltration (Mepivacaine) Transnasal sphenopalatine ganglion block (Levobupivacaine 7,5%)

A cotton swab soaked in levobupivacaine 7,5% in inserted into the nose to block sphenopalatine ganglion, with the classic technique previously described

Sphenopalatine ganglion block

Troncular scalp blockade. Local site infiltration

Alba Scerrati, MD

Giorgio Mantovani, MD

Pasquale De Bonis, MD PhD

Post craniotomy pain is defined as headache developed up to 7 days from a craniotomy, not otherwise explained. A moderate to severe pain affects from 60 to 84% of patients.

Sphenopalatine ganglion block has been successfully used in patients with chronic or acute headache, facial pain and for transsphenoidal pituitary and endoscopic sinus surgeries.

There are evidences that sphenopalatine ganglion block reduces vegetative responses to skull pin closure.

This study aim to investigate feasibility and efficacy of sphenopalatine ganglion block in reducing pain after a neurosurgical supratentorial craniotomy.

Sphenopalatine Ganglion Block and Pain Management in Neurosurgery

From 0 (no pain) to 10 (worst pain ever) on a straight line

From 0 (no signs of pain) to 10 (Extreme pain)

Bitter taste, nose bleeding, throat discomfort

University Hospital of Ferrara

Wounds and Injuries

Dermatitis

Breast Neoplasms

Radiodermatitis

Breast Diseases

Skin Diseases

Two of four regions of the breast will be randomly chosen to receive 3M Cavilon No Sting Barrier Film treatment twice per week.

Half the breast will receive 3M Cavilon No Sting Barrier Film and one half will receive standard skin care

3M Cavilon No Sting Barrier Film

Michael Lock, MD, FRCPC

To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer.

Rationale

Radiation dermatitis is a common problem in a significant proportion of breast cancer patients. In addition, radiation dermatitis is a quantifiable complication which is relatively easily observed and graded according to modified Radiation Therapy Oncology Group (RTOG) criteria for toxicity. Radiation dermatitis is thought to be related to abrasion that degrades the keratinized skin surface. This results in decreased ability of skin stem cells to regenerate which leads to moist desquamation. A barrier film could potentially form a protective scaffold for new skin growth and repair. Cavilon No Sting Barrier Film (BF) has been shown in randomized trials involving post-mastectomy radiation patients to reduce the duration and frequency of radiation-induced moist desquamation. However, this treatment has not been studied in the statistically more prevalent situation of an intact breast. Therefore, we propose to investigate Cavilon to reduce side-effects of radiation treatment in intact breast cancer patients treated with conservative surgery and adjuvant radiation therapy.

2.0 STUDY OBJECTIVES 2.1 Primary Objectives To evaluate effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer. The grading of dermatitis will be obtained according to modified RTOG scale for visual assessment of radiation-induced skin erythema. This is attached as Appendix A. In addition, Skin Toxicity Assessment Tool (STAT) will also be used by the patient and physician validated against the quality of life tools and toxicity tools. This is attached as Appendix B.

2.2 Secondary Objectives Quality of Life The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) will be used to measure overall quality of life. Quality of life has been considered an important contributor to overall performance status and outcome. Quality of life consists of multiple components (e.g. physical, social, and psychological aspects, etc.). Improved quality of life translates into better outcomes, especially in the context of palliation. Global quality of life was found to be significantly associated with survival in a general population of cancer patients in Canada . In fact, many clinical trials in palliative care include improved quality of life for cancer patients as a primary outcome. The EORTC Quality of Life Questionnaire (QLQ-C30) was developed in Europe and is frequently used to measure quality of life and its related components . The EORTC QLQ C-30 is attached in appendix C.

Time to develop radiation dermatitis On each follow up visit, all patients will be assessed for development of any grade of radiation dermatitis. The time to develop grade I, II and or grade III radiation dermatitis will be calculated from the date of first dose of radiation therapy delivered to the date of visit at which the grade of dermatitis is observed. Time to additional treatment, i.e. over-the-counter or prescription interventions, will also be measured.

Image An observer, blind to the regions treated by Cavilon, will also grade each paired photographic image.

Qualitative Questions Qualitative questions are meant to ask personal opinion and perspectives. The answers provide further insight into the related issue or question. We have designed a very simple approach with 2-3 open-ended questions for both patient and practitioner. See Appendix D.

3.0 OVERALL STUDY DESIGN AND PLAN 3.1 Study Design Randomized paired comparison design, conducted at a single centre, the London Regional Cancer Program (LRCP), Ontario, Canada. A total of 47 patients will be accrued for this study. Eligible patients will be contacted and study details will be reviewed with them. The schedule for BF will be two times per week throughout the duration of radiation therapy. Each BF treatment will be applied immediately before radiation treatment by the radiation therapist using a film template. The template is a cellophane sheet with two quadrants physically removed. The quadrants removed will be randomly selected to receive the film spray treatment. The template is used only at the time of BF application. Other quadrants may receive standard treatment. No placebos will be used. To ensure the template is placed at the correct location for each treatment, localization will use the permanent tattoos used for radiation treatment localization. This is an intention-to-treat trial.

3.1.1 Baseline/Accrual (Visit 1)

Patients with a histopathologically or cytologically confirmed diagnosis of breast cancer scheduled to receive adjuvant radiation therapy may be screened. The following procedures/assessments will take place during this visit for the patient:

* Obtaining written informed consent
* Reviewing inclusion/exclusion criteria
* Obtaining disease history, including date of first diagnosis, and the history of the course of the patient's histopathologically or cytologically confirmed diagnosis of breast cancer, and information about prior radiation or chemotherapy
* Obtaining medical history (past or concurrent clinically significant disease(s))
* Obtaining demographic data including history of radiation sensitivity or radiation sensitizers
* Obtaining information about any planned treatment
* Perform a general physical examination
* A patient who meets all eligibility criteria will be enrolled in the study and the following additional procedures will be performed:
* Completion of questionnaire for STAT, modified RTOG visual assessment of erythema, qualitative questionnaire and QLQ-C30
* Assign two of four regions by random number list

3.1.2 Treatment Phase (Weekly assessment)

After the Baseline visit, patients will return to the study site for scheduled follow-up visits, also called Patient Review (PR). The following procedures/assessments will be performed during these visits:

* Evaluation and documentation of any grade radiation dermatitis using STAT and the modified RTOG erythema scale
* Documentation of any new medication use including use of skin creams

3.1.3 Follow-up Visit (One week post treatment completion)

The following procedures/assessments will be performed during the follow-up visit:

* Evaluation and documentation of any grade radiation dermatitis
* Completion of questionnaire for QLQ-C30
* Completion of qualitative questions
* Completion of global questionnaire

4.0 SELECTION OF STUDY POPULATION

The study will be conducted in patients with histopathologically or cytologically confirmed diagnosis of breast cancer, scheduled to receive adjuvant radiation therapy as outpatients at the London Health Sciences Centre, London, Ontario.

5.0 STATISTICAL EVALUATION 5.1 Determination of Sample Size The primary endpoint will be a comparison of region 1 (region treated with standard care) and region 2 (region treated with BF). Based on the same endpoint measure, we estimate the baseline/standard care risk of grade 2 toxicity and higher to be approximately 60% at any point during the assessment period. Studies with the same and similar products demonstrate an expected reduction of grade 2 or higher toxicity to approximately 30%. This is also a clinically important significant difference . The sample size required is 42 (paired analysis). This assumes a Type I error of 0.05 and a power of 80% to reject the null hypothesis. With an expected 5% excess added due to loss to follow up or non-evaluable data, we would require a sample size of 47 patients. This is consistent with landmark Uppsala randomized study demonstrating the value of corticosteroid cream with 42 patients.

5.2 Statistical Analysis SAS (SAS Institute, Cary, NC) was used to generate a random allocation list with two stratification blocks (i. chemo no chemo; ii. breast separation).The physician will be unaware of the treatment allocation, but the patient and radiation therapist administering the film will not be blinded. For qualitative measures, McNemar's (McNemar) chi-square test for paired proportions will be used. For quantitative measures, a paired t-test or a signed rank test will be used. For the 'time to event' variables that will be paired, Kaplan Meier estimates to graphically demonstrate the 'time to event' will be used. The statistical comparisons will be performed using proportional hazards models with a sandwich estimator to account for the pairing with a sandwich estimator. A repeated measures ANOVA will be used to assess the four quadrants. If the data is poorly distributed then we will take a median of the two treated areas and two control areas and apply a singed rank test. Note that this is not the principle endpoint of the trial. The principle endpoint of the trial is a 1-to-1 comparison of the BF treated area and the area treated using standard options. A multivariable analysis will be performed to determine factors impacting on skin toxicity. The multivariable analysis will not be used for between patient comparisons as differences will be accounted for by the pairing. All significant tests will be two-sided and performed at the 5% level.

within patient randomization of Cavilon skin spray

within patient randomization. One half of breast received Cavilon and other receives standard of care treatment. Care provider is blinded as to portion receiving treatment.

Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation

Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Women With Breast Cancer Receiving Adjuvant Radiation Therapy

Release as requested and via publication access notification

cost will be measured in Canadian dollars. The cost of standard care will be assessed by direct patient questioning on what was purchased. The cost of the Cavilon is standard for all patients (currently $28)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Curcumin Gel On Radiation Induced Oral Mucositis	NCT05982197	Radiation-Induc... Head and Neck C...	Curcumin Gel Standard Prepar...	16 Years - 80 Years	University of Baghdad
Preoperative Music Listening in Odontostomatological Surgery (PMLOS)	NCT05417529	Stage I or II M...	music therapy i... Standard Prepar...	18 Years -	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Preoperative Music Listening in Odontostomatological Surgery (PMLOS)	NCT05417529	Stage I or II M...	music therapy i... Standard Prepar...	18 Years -	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sphenopalatine Ganglion Block and Pain Management in Neurosurgery	NCT05136625	Post Operative ... Craniofacial Pa...	Sphenopalatine ... Standard Prepar...	18 Years -	University Hospital of Ferrara
Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation	NCT01762020	Breast Cancer Dermatitis	3M Cavilon No S... Standard Prepar...	18 Years - 80 Years	Lawson Health Research Institute
Preoperative Music Listening in Odontostomatological Surgery (PMLOS)	NCT05417529	Stage I or II M...	music therapy i... Standard Prepar...	18 Years -	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Spots Global Cancer Trial Database for standard preparation