Symptoms and General Pathology

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Ulcer

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Herbal and Botanical

All Drugs and Chemicals

Chamomile

1. The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs).
2. Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
3. Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
4. Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

1. The plain icecubes will be prepared in the clinic with 400 mL of distilled water.
2. Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
3. Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
4. Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs). Patients are asked to swish the chamomile ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

Chamomile oral cryotherapy

The plain icecubes will be prepared in the clinic with 400 mL of distilled water. Patients are asked to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

Oral cryotherapy

Dina Y Essa, B.D.SC

Nada M Wassef, PHD

Dina Yousef

Norhan A Eldokkky, PHD

oral mucositis is a painful situation that significantly affects patients' quality of life with the severe cases being associated with ulcerated mucosa and secondary infection which may lead to life-threatening sepsis.Chamomile infusion in cryotherapy was used to aid in reduction of chemotherapy induced mucositis and to enhance the effect of standard cryotherapy alone by its anti-inflammatory, antifungal and antibacterial effect. The occurrence of oral mucositis is a significant complication of chemotherapy with prevalence of up to 80% in pediatric patients.The study is to be conducted at the in and outpatient clinics at the Department of Pediatric Oncology, National Cancer Institute,Egypt. A Structured interview questionnaire sheet will be filled with personal, medical and dental history. Intraoral examination will be carried out using sterile latex gloves, masks, plain mouth mirrors, sterile gauze and wooden tongue depressor. Patients who will agree to participate in the study will watch a video explaining how to perform oral hygiene.Preparation of the interventions is done in the clinic with 400 ml of distilled water with or without the infusion of 10 g of chamomile flowers."Chamomile classic infusion, Royal Herbs" .Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session. Follow ups are done at the 8th,15th and the 21st day of interventions application.

Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.

Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy: (A Randomized Pilot Study)

Primary outcome is measured using Children International Mucostitis Evaluation Scale (CHIMES).ChIMES1-4 each received a score of 0-5 where 5 is the worst degree of symptoms. ChIMES5 and ChIMES6 received a score of 1 or 0 if the child had received pain medications or not. Finally, ChIMES7 received a score of 1or 0 if oral ulcers were present or not. Any question that was scored as missing or 'I can't tell' was excluded from the total possible score. If all the questions were answered, the maximum score was 23. The ChIMES Total Score was the sum of all scores; 'I can't tell' responses and missing responses both received a score of 0. The ChIMES Percentage Score was the ChIMES Total Score over the total maximum score taking into account 'I can't tell' responses (by subtracting these items from the maximum score) multiplied by 100. Higher values indicate a worse outcome.

Assessed using Oral Mucositis World Health Organization Toxicity Scale.It represents grades of oral mucositis ranging from 0-4 with higher grades indicating worse outcome.

National Cancer Institute, Egypt

Cairo University

Master Degree Student

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Breast Neoplasms

Nausea

Vomiting

Breast Diseases

Skin Diseases

Signs and Symptoms, Digestive

Acute Graft Versus Host Disease

1. Teaching of oral cryotherapy by the investigator in the hospital,
2. Implementation of oral cryotherapy accompanied by the investigator in the hospital
3. Individual application of oral cryotherapy at home by patients

Routine procedures in the clinic were performed on the first course (day 0) when the patients came to receive adjuvant chemotherapy and every 21 days thereafter, and oral cryotherapy was not applied to the patients. Before applying the first adjuvant chemotherapy, Nausea Vomiting Training and Guide was given to have equal conditions with the patients in the intervention groups.

Ice application protocol developed by the researcher by scanning the literature was prepared by taking the opinions of 5 faculty members who are experts in their fields. Also, the chamber of physics engineers and the chamber of chemical engineers' opinion was taken for the necessary corrections or improvements regarding the chemical/physical structure of the ice and the method applied. In the content of the protocol, materials, preparation before intraoral ice application (written and visual), steps of intraoral ice application (written and visual), termination of intraoral ice application, recording of intraoral ice application, and situations to be considered are explained in detail respectively.

oral cryotherapy

Berna Çakmak Öksüzoğlu, Professor

The purpose of this randomized controlled, statistical blind study that has an intervention control group was to determine the effect of oral cryotherapy on anticipatory, acute, and late nausea and vomiting of breast cancer patients receiving adjuvant chemotherapy. The study was carried out between July 2020-May 2021 in the Unit of the Medical Oncology Department of University of Health Sciences Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. The study sample consisted of 54 breast cancer patients. 26 patients belonged to the intervention group and 28 to the control group. They were stratified based on their ages and body surface areas and were planned to receive chemotherapy for four cycles. The Oral Cryotherapy Protocol; developed by the researcher was made by obtaining opinions of five academic members and physics engineers and chemical engineers. Nausea and vomiting training guide and education was given to all patients in the study to avoid discrimination. The intervention group of the study applied oral cryotherapy with the researcher when they came to the hospital for the treatment and at home. No procedure outside of the routine treatment was performed on patients in the control group. Data in the study were collected through the Patient Information Form, the Rhodes Index of Nausea Vomiting and Retching (RINVR), and the EORTC QLQ-C30 Life Quality Index. The effect of oral cryotherapy was measured by the RINVR by contacting the patients every day for the first week during four cycles. EORTC QLQ-C30 and RINVR were conducted on patients when they came to the hospital throughout their cycles.

Nausea-vomiting (80%) is the leading symptom associated with chemotherapy. The chemotherapeutic regimen's emetogenicity is effective in the emergence of chemotherapy-induced nausea-vomiting (CINV). In CINV, centers such as the cerebral cortex and the gastrointestinal tract stimulated the Chemoreceptor Trigger Zone (CTZ). Cytotoxic drugs can easily reach the CTZ. Various emetogenic cause serotonin release from enterochromaffin cells in the gastrointestinal tract. Serotonin stimulates CTZ in the central nervous system, and emesis develops. Despite the antiemetic drugs given to prevent the side effects of chemotherapy drugs, 60% of patients experience nausea and vomiting. Adriamycin Cyclophosphamide (AC) chemotherapy agents often cause nausea and vomiting between 1-7th days after the treatment. When CINV cannot be controlled effectively and adequately, anticipatory nausea and vomiting develop, especially within 24 hours before chemotherapy treatment, and a learned reflex mechanism occurs. It is stated that uncontrolled anticipatory nausea and vomiting in adult patients triggers acute and late nausea and vomiting. It is indicated that approximately 70% of the patients who received chemotherapy treatment between the first and fifth days experienced vomiting at least once, and 80% of the patients experienced nausea at least once.

The guideline for the prevention and management of nausea-vomiting published by the Oncology Nursing Society (ONS) states that the use of non-pharmacological approaches together with pharmacological methods may be appropriate. One of the nonpharmacological applications recommended in the management of chemotherapy-related symptoms is oral cryotherapy. Cryotherapy is the process of cooling the tissues by utilizing the effect of pieces of ice. Cryotherapy causes local vasoconstriction when used in treatment with intravenously administered chemotherapy agents. The local effect of ice application in preventing muscle damage is that it causes vasoconstriction in blood and lymph vessels, reducing the inflammatory response and activation of some proteins. The most important neuroreceptors in the formation of the emetic response are serotonin, substance-P, dopamine, acetylcholine, corticosteroid, and histamine. The most important neurotransmitters are dopamine, serotonin, and substance-P. Substance-P stimulates cholinergic neurons, causing vasodilation, increased secretion, and smooth muscle contraction. This way, it triggers vomiting by stimulating the CTZ.

The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients

The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients Receiving Adjuvant Chemotherapy Treatment

The scale has three sub-dimensions as symptom experience, symptom occurrence, and symptom distress.

The scale consists of three sub-dimensions as general well-being, functional difficulties, and symptom control.

Berna KURT

Principal Investigator

Gland and Hormone Related Diseases

Nervous System Diseases

Esophageal Neoplasms

Carcinoma

Pancreatic Neoplasms

Stomach Neoplasms

Peripheral Nervous System Diseases

Neuroendocrine Tumors

Gastrointestinal Neoplasms

Carcinoma, Ductal

Digestive System Neoplasms

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuromuscular Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Diseases

Esophageal Cancer

Pancreatic Cancer

Bile Duct Cancer

Stomach Cancer

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Intrahepatic Cholangiocarcinoma

Pancreatic Neuroendocrine Tumor

Anal Cancer

Small Intestine Cancer

Neuroepithelioma

Antineoplastic Agents

Oxaliplatin

Fluorouracil

Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.

Patients undergo standard of care oral cryotherapy.

Acupuncture Therapy

Acupressure Therapy

Oral Cryotherapy

Questionnaire Administration

Quality-of-Life Assessment

Stacey Cohen

This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.

ARM II: Patients undergo standard of care oral cryotherapy.

Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer

Pilot Study of Oral Cryotherapy vs. Oral Cryotherapy Plus Acupuncture and Acupressure to Decrease Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy for GI Cancers

Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.

Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate.

The Neuropen is used to assess touch and pressure perception as well as protective pain and sharpness sensation. Touch and pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot. Pain and subjective sharpness sensation will be assessed using the 40-g Neurotip on the dominant foot. Loss of pain and pressure sensation are associated with increased CIPN.

A study-specific 128-Hz tuning fork will be used to assess vibration sensation on dominant lower extremity and dominant upper extremity sites. If the patient feels the vibration for 15 seconds or longer, this is defined as normal. If the patient feels the vibration less than 15 seconds, this is defined as absent or decreased vibration sensation. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN.

Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted.

Measured by patient-reported (National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE, Brief Pain Inventory \[BPI\], oral dysesthesia) and provider-assessed (CTCAE version 5) grading scales.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.	NCT03605186	Oral Mucositis ...	Chamomile oral ... Oral cryotherap...	6 Years - 18 Years	Cairo University
The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients	NCT05138627	Breast Cancer	oral cryotherap...	18 Years - 65 Years	Hacettepe University
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.	NCT03605186	Oral Mucositis ...	Chamomile oral ... Oral cryotherap...	6 Years - 18 Years	Cairo University
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer	NCT04505553	Appendix Carcin... Colon Carcinoma Esophageal Carc... Gastric Carcino... Liver and Intra... Malignant Diges... Pancreatic Carc... Rectal Carcinom... Small Intestina... Anal Carcinoma Digestive Syste... Digestive Syste... Pancreatic Neur...	Acupuncture The... Acupressure The... Oral Cryotherap... Questionnaire A... Quality-of-Life...	18 Years -	University of Washington

Spots Global Cancer Trial Database for oral cryotherapy