Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

manuka honey

Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

placebo gel

Philippa Hawley, B.Med

The primary hypothesis of this study is that regular topical oral application of Manuka Honey will reduce the severity and duration of oral mucositis in patients who are undergoing mucotoxic radiation therapy for cancer treatment.

Oral mucositis is a common side-effect of radiation therapy for many head and neck cancers, and can have a very severe impact on quality of life and nutritional status. At least42% of patients treated for head and neck cancers will develop grade 3 or 4 oral mucositis. Although there have been positive trials, no study has had overwhelming data to strongly support any one agent in the prevention or treatment of oral mucositis. A comprehensive review of the literature done in 2004 found only benzydamine (a topical nonsteroidal anti-inflammatory agent) to be beneficial as a palliative treatment for established mucositis. Management essentially consists of pain management, with topical and oral analgesics/anaesthetics and anti-inflammatory agents, and nutritional support, once mucositis is established. Despite the use of these agents, many patients still have severe mucositis, and there is great need for new treatments to reduce this distressing complication of cancer therapy.

Currently, the only standard "treatment" consists of an oral rinse of warm water, salt, and baking soda 4 times a day. This is only to maintain oral hygiene and does not have any impact on the severity or duration of the mucositis itself. Topical fluoride is applied at bedtime to reduce the caries risk. Basic oral care (brushing and flossing as tolerated) is recommended to maintain general mucosal health and to reduce the impact of oral microbial flora.

Study Objectives The primary objective of this study is to see if topical oral Manuka honey reduces the severity of mucositis in patients receiving radiation treatment for head and neck cancer. Secondary objectives are to assess the impact of any demonstrated improvement in mucositis on nutrition, symptom burden, quality of life, and radiotherapy treatment interruptions.

The study was blinded to all except necessary pharmacy staff until after the study was closed.

A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer

Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.

British Columbia Cancer Agency

Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed

manuka honey: Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

Honey

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

placebo gel: Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.

Placebo

Total

Not all patients have baseline information available

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Weight

Diabetic

Smoker

ECOG > 0

Chemotherapy

Gy = Gray; the international system unit of radiation dose

Radiation Therapy => 7,000 Gy

Dr. Philippa Hawley

Patients who had at least one mucositis assessment were included in this analysis

Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment

Patients who had a minimum of 2 mucositis assessments were included in this analysis

Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments

Overall Study

Symptoms and General Pathology

Wounds and Injuries

Neoplasm Metastasis

Neoplastic Processes

Dermatologic Agents

All Drugs and Chemicals

Petrolatum

Participants in this group will receive the experimental APIS Biomaterial on the Head. One layer of APIS® will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.

Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities. One layer of APIS® will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.

Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

One layer of APIS® will be applied to the post-operative wound on the head covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Participants in this group will receive the experimental APIS Biomaterial on the Head.

One layer of APIS® will be applied to the post-operative wound on the lower extremities covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.

Standard Secondary Intention Healing on the Head

Standard Secondary Intention Healing on the Lower Extremities

Anna S Clayton, MD

The purpose of this study is to elucidate if a novel biomaterial containing gelatin, manuka honey, and hydroxyapatite enhances secondary intention healing when compared to conventional secondary intention healing for surgical defects after Mohs micrographic surgery on the head and distal lower extremities (below the knee). This novel biomaterial has already been FDA cleared for surgical wounds.

Secondary intention healing (SIH) is often underutilized and has several advantages compared to primary surgical repair. Wound care is minimal, bleeding and infection are rare, and risks associated with primary closure (e.g. hematoma, suture granuloma, graft or flap failure) are non-existent. Importantly, SIH facilitates surveillance of tumor recurrence, whereas flaps and grafts may bury residual tumor. When used in appropriate anatomical locations, SIH leads to high patient satisfaction. However, SIH requires regular wound care that can be cumbersome to patients.

Prior studies utilizing biologic dressings have shown patients report better quality of life during the post-operative period related to less pain, decreased dressing changes, and faster healing times. Biologic dressings provide an alternative to surgical autografts and eliminate the risks associated with graft harvesting (e.g. pain, infection, and scarring). For many patients, the cosmetic outcome following healing is important. However, cosmetic outcome with SIH is variable and depends on many factors, namely location (e.g. concavities favorable), skin laxity, and underlying musculature. Exuberant granulation tissue, hypopigmented and telangiectatic scars are the most frequent adverse cosmetic outcomes with SIH.

The novel biomaterial APIS® (SweetBio, Inc. Memphis, TN) is an advanced synthesis of gelatin, manuka honey, and hydroxyapatite bioengineered to protect wounds, manage exudate, and maintain a moist environment. It is FDA cleared (FDA number K1827250) for wound management across 9 indications including surgical wounds. It has been used successfully in a small case series of 8 patients for post-operative Mohs surgical wounds on the head and distal lower extremities. Time to complete re-epithelialization was 6 weeks (42 days), suggesting a reduction in healing time compared to standard SIH times for the leg and head of 127 and 57 days, respectively. Use of this novel biomaterial to enhance SIH is hypothesized to reduce healing times when compared to standard SIH wound care. This provides a useful option to aid SIH in sites like the lower legs, where healing can be prolonged due to intrinsic factors (e.g., cardiovascular disease, peripheral vascular disease, diabetes) or extrinsic factors (e.g., increased risk of surgical site infection following dermatologic surgery at sites below the knee).

Randomized, comparative studies evaluating augmented SIH compared to conventional SIH in dermatologic surgery are limited. This study aims to evaluate whether use of a novel biomaterial enhances SIH, particularly in shortening time to complete re-epithelialization. Patients undergoing Mohs micrographic surgery amenable to SIH on the head and distal lower extremities will be randomized into one of four groups (standard SIH or biomaterial APIS® enhanced SIH on the head or distal lower extremities). Patients will have regularly scheduled follow-up with questionnaires at each visit. The investigators aim to evaluate whether use of this novel biomaterial decreases complete re-epithelialization times, reduces infection rates, and improves cosmetic outcomes.

Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities

Novel Biomaterial Containing Gelatin, Manuka Honey, and Hydroxyapatite Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities - A Randomized Clinical Trial

Complete wound re-epithelialization is defined by epidermal regrowth covering entire post-operative defect. Patients will be seen in office 14 days post-operative, then every 14 days thereafter until complete re-epithelialization is achieved. Patients will also submit photos via Vanderbilt HIPAA compliant Box at regular follow-up intervals (post-operative day 7 then every 14 days thereafter until complete re-epithelialization is achieved). Time elapsed from surgery date to complete re-epithelialization will be noted in days.

Time will be measured in days. Increased days indicates slower wound healing.

Patients self-reported their surgical site/wound pain during each 2-week follow-up visit via a questionnaire. Scores were collected from participants until complete wound re-epithelialization, which was approximately 5 months for each participant.

Pain scale will range from 1 (no pain) to 10 (worst pain imaginable). These pain scores were then averaged amongst the participants included in each arm.

Post-operative wounds will be assessed for infection at regularly scheduled follow-ups. Any clinically suspected infection (e.g. erythema, purulence, malodor) will be reported.

Patients will report any bleeding (yes/no) via questionnaires at regularly scheduled follow-up appointments.

Participants were given a questionnaire at the final visit when complete wound re-epithelialization had been achieved (which was approximately 5 months for each participant) and asked, "Is the thickness of the scar different from your normal skin at present?" Participants reported on a scale of 1 (no, as normal skin) to 10 (yes, very different). These skin thickness scores were then averaged amongst the participants included in each arm.

Vanderbilt University Medical Center

Dermatology Resident Physician

Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.

Participants in this group will receive the experimental APIS Biomaterial on the Head. One layer of APIS® will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.

Participants in this group will receive the experimental APIS Biomaterial on the Head.: One layer of APIS® will be applied to the post-operative wound on the head covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

APIS Biomaterial on the Head

Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities. One layer of APIS® will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.

Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.: One layer of APIS® will be applied to the post-operative wound on the lower extremities covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

APIS Biomaterial on the Lower Extremities

Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Standard Secondary Intention Healing on the Head: Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Standard Secondary Intention Healing on the Lower Extremities: Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Participants received the experimental APIS biomaterial on the head. One layer of APIS biomaterial will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.

APIS Biomaterial on the Head (Intervention Group)

Participants in this group received standard secondary intention wound healing post-operative care on the head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Standard Secondary Intention Healing on the Head (Control Group)

Participants received the experimental APIS biomaterial on the distal lower extremities. One layer of APIS biomaterial will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.

APIS Biomaterial on the Lower Extremities (Intervention Group)

Participants in this group received standard secondary intention wound healing post-operative care on the distal lower extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Standard Secondary Intention Healing on the Lower Extremities (Control Group)

United States

Region of Enrollment

Sixteen patients with surgical defects on the lower extremities amenable and conducive for SIH were randomized to intervention or control by block randomization. Subjects were randomized in a 1:1 ratio. Twenty-one patients with surgical defects on the head were randomized in the same manner.

It was difficult to enroll patients during the COVID-19 pandemic as regular follow up visits were required.

Of the 21 patients enrolled in the head group, two were lost to follow up. The low infection rate could possibly be attributed to patients with defects on the distal lower extremities receiving prophylactic antibiotics. Photos taken at follow-up visits were not taken in standardized format, so the difference in wound healing may not be as evident photographically as it was clinically.

Karen Arnaud

APIS Biomaterial on Head (Intervention Group)

Of the 21 randomized in the head group, 11 were randomized to the intervention group and 10 to the control group. One participant from the intervention group, and one participant from the control group were lost to follow up before complete re-epithelialization was achieved.

Time to Complete Wound Re-epithelialization on the Head

Analysis of re-epithelialization of wounds of the lower extremities with standard secondary intention healing versus APIS biomaterial.

Time to Complete Wound Re-epithelialization on the Lower Extremities

Participants received the experimental APIS biomaterial on the lower extremities. One layer of APIS biomaterial will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.

Participants in this group received standard secondary intention wound healing post-operative care on the lower extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Patient Self Reported Pain Score

Number of Participants With at Least One Post-Operative Wound Infection

Participants in this group received standard secondary intention wound healing post-operative care on the lower extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape

Number of Participants With at Least One Report of Post-operative Bleeding

Two patients in the intervention group for the head, 2 patients in control group for the head, 1 patient in intervention group for lower extremities and 1 patient in control group for lower extremities failed to complete a final questionnaire on scar assessment.

Skin Thickness

Blood and Lymph Conditions

Leukemia

Pain

Neoplasms by Histologic Type

Hematologic Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Pharmaceutical Solutions

Anti-Infective Agents

Herbal and Botanical

Lidocaine

Nystatin

Olive

Efficacy of Manuka honey on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial.

Efficacy of olive oil on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial.

The control group at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine

5 for children or 10cc of honey for adults was ordered directly from a New Zealand company

Manuka honey

5 cc of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon will be given.

olive oil

Control at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine).

Control group

lina K Badr, PhD

Rima Saad, MSN

Rebecca El Asmar, MSN

Background: Oral mucositis (OM) is a significant complication occurring in approximately 40% of patients on chemotherapy regimens. Ulcerative lesions of OM can be very painful, with negative impact on diet, oral hygiene, and quality of life. Although a wide variety of agents have been tested to prevent OM or reduce its severity, none have provided conclusive evidence.

Objectives of this study will be: to determine the efficacy of honey or olive oil on the severity and pain of OM compared to placebo (standard care) and, (2) to assess which of the two interventions is more beneficial.

Research Questions:

1. Children/adults who receive honey (group 1) or olive oil (group 2) will have less severe OM compared to the control group (Severity is measured by recovery time from OM and is the primary outcome)
2. Children/adults who receive honey (group 1) OR Olive oil (group 2) will have less pain than the control group. (Severity of pain is the secondary outcome Methods: A randomized controlled study (RCT) will be used to evaluate the effect of topical application of honey or olive oil, in the treatment of chemotherapy-related OM in 60 participants with OM. The primary outcome will be the severity of mucositis, assessed by four trained nurses blinded to the study group using the scale presented by the World Health Organization (WHO). The secondary outcome will be pain also assessed by the four trained nurses on the visual analogue scale ort eh Wong Faces scale.

The relevance of this study lies in the possibility of challenging nurses in regard to the problem of OM and in proving a possible herbal cure that may influence clinical practice.

Data analysis: The characteristics of the three groups will be described using mean and SD, frequencies and percentages. Baseline differences between the two groups will be tested using ANOVA for continuous data, and the Chi-square for categorical data. Kruskall-Wallis (chi square) test will be used to find the association group assignment and WHO grades of OM and ANOVA and RANOVA tests will be used to find the association between group assignment and the pain scores. Bonferroni tests will be conducted to explore which of the three groups has the better outcomes.

When parents or adults express interest in the study they will be approached by the Principal investigator (LKB) or the 2 research nurses (RS or RA) who will make contact with the children and their parents and explain the study, ,answer all their questions and concerns and inform them about the study benefits/potential risks (see recruitment script appendix B in proposal). If a parent approves to participate in the study, he/she will sign an informed consent and any child above 7 will be asked to sign an assent form. The investigator will also assure the parents that participation is totally voluntary and it is not a part of the conventional treatment and that they have the full right to refuse participating and withdraw from the study at any time, even after signing the consent.

Recruitment activities will take when the children are hospitalized at the Children's cancer center in Lebanon (CCCL), 8 North and the Bone Marrow unit (BMT). Patients, parents and children will also have access to flyers in the unit briefly explaining the study. Potential subjects will be identified through reviewing daily census on the inpatient unit of CCCL, 8 north or the BMT unit. Participates will be screened for eligibility and will be excluded if they have any condition that may affect the efficacy of treatment as listed in the exclusion criteria. Participants will be randomly assigned to 1 of 3 groups, 20 patients in each group. The randomization method will be prepared in advance by a statistician not involved in the study, using a paper list-generated random assignment sequencel. Based on group assignment, participants will receive a different compound applied topically to the oral mucosa 3 times daily until healing, or for 7 days, whichever comes first.

Group 1 will receive 10cc of honey for adults and 5 cc for children, which will be supplied directly from a New Zealand.

Group 2 will receive maximum 5 g of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon. It will be stored in dark containers at room temperature for use in the study.

Group 3 will serve as control, which at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine).

Groups 1 and 2 patients will be instructed to slowly rinse the honey or olive oil in their mouths, swish it around for 1 minute duration, so as to make the honey or oil in contact with the oral mucosa and slowly swallow so as to make better contact with the pharyngeal mucosa. For group 3, patients will swish the respective solution for 1 minute then spit it out. The order of the different solutions will be written in each medical record by the attending physician and the nurse will observe the patient taking the solution and will document the administration on the hospital flowsheet.

The independent variable for this study is either olive oil or honey The dependent variables will be primary and secondary:

1. The primary outcome will be the severity of OM measured by recovery time, defined as the number of days from the initiation of treatment until healing or day 7 assessed by four trained nurses on a daily basis and who are blinded to the study group using the scale presented by the World Health Organization (WHO). The WHO scale is based upon the ability to eat and drink combined with objective signs of mucositis, namely erythema and ulceration (7). Visualisation of the oral cavity is critical for scoring, as the presence of oral ulcers delineates a WHO mucositis grade which ranges from 0 to 4 where higher scores correspond to worse mucositis. The WHO scale is classified as follows: grade 0=normal, no mucositis; grade 1=soreness and erythema; grade 2=erythema, ulcer, can eat solids; grade 3=ulcers, require liquid diet only; grade 4=alimentation not possible. The PI will establish inte-rater reliability with the four nurses by assessing patients on the WHO scale. Each nurse will conduct the assessment and compare her/his results with the PI, this will be done until a reliability of \>. 80 is achieved. Reliability will be done before the study begins and then every month until the completion of the study.
2. The secondary outcome will be a pain assessed as per the institution's policy using the Visual analogue 10cm scale (VAS) or the Wong faces scale. A 0 indicates no mouth or throat pain and 10 indicates the most severe mouth or throat pain ( see appendix E in the proposal). The construct, convergent and predictive validity of the VAS and the Faces scales have been widely published (26). Pain scores of the oral mucosa will be conducted twice a daily for study purposes. The patients will be assessed by their RNs for pain which is documented in the patient charts twice per day in the morign and in the evening (even in the absence of pain).

Pain scores of the oral mucosa will be conducted twice a daily for study purposes. The patients will be assessed by their RNs for pain which is documented in the patient charts twice per day in the morign and in the evening (even in the absence of pain), the nurses will have no knowlegde of group assignment.

Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy

"The Efficacy of Honey or Olive Oil on the Severity and Pain of Oral Mucositis Compared to Placebo (Standard Care) in Children With Leukemia Receiving Intensive Chemotherapy

Defined as the number of days from the initiation of treatment until healing or day 7 assessed by four trained nurses on a daily basis and who are blinded to the study group using the World Health Organization (WHO) scale. The WHO scale is based upon the ability to eat and drink combined with objective signs of mucositis, namely erythema and ulceration. Visualisation of the oral cavity is critical for scoring, as the presence of oral ulcers delineates a WHO mucositis grade which ranges from 0 to 4 where higher scores correspond to worse mucositis. The PI will establish inte-rater reliability with the four nurses by assessing patients on the WHO scale. Each nurse will conduct the assessment and compare her/his results with the PI, this will be done until a reliability of \>. 80 is achieved. Reliability will be done before the study begins and then every month until the completion of the study.

Pain assessed as per the institution's policy using the Visual analogue 10cm scale (VAS) or the Wong faces scale. A 0 indicates no mouth or throat pain and 10 indicates the most severe mouth or throat pain ( see appendix E in the proposal). The construct, convergent and predictive validity of the VAS and the Faces scales have been widely published (26). Pain scores of the oral mucosa will be conducted twice a daily for study purposes. The patients will be assessed by their RNs for pain which is documented in the patient charts twice per day in the morning and in the evening (even in the absence of pain).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer	NCT00615420	Radiotherapy In... Head and Neck C...	manuka honey placebo gel	-	British Columbia Cancer Agency
Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities	NCT04545476	Wound Heal	Participants in... Participants in... Standard Second... Standard Second...	18 Years -	Vanderbilt University Medical Center
Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy	NCT03399331	Oral Mucositis Leukemia	Manuka honey olive oil Control group	5 Years -	American University of Beirut Medical Center

Spots Global Cancer Trial Database for manuka honey

Every month we try and update this database with for manuka honey cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.