Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Lymphoma

Hematologic Neoplasms

Cancer Pain

Pain

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Neoplastic Processes

Neurologic Manifestations

Lymphosarcoma

Antipyretics

Analgesics

All Drugs and Chemicals

Acetaminophen

A 3+3 design for Phase I component and a two staged design for Phase II were to be used. Treatment: Sodium Bicarbonate Capsules (900 mg).

Cohort 1 patients will take 10 capsules/day; cohort 2 patients will take 20 capsules/day; cohort 3 patients will take 30 capsules/day and cohort 4 patients will take 40 capsules/day. Cohort 2 - 4 patients will begin at the cohort 1 dose and dose escalate to their respective cohort doses in order to prevent any side effects associated with alkalosis. Dose escalation will occur at a rate of 10 capsules/week.

Sodium Bicarbonate

Amit Mahipal, M.D.

The purpose of this study is to:

* Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
* Determine if sodium bicarbonate can reduce cancer-related pain.

Single institution Phase I/II study of sodium bicarbonate in combination with standard medical management for patients with moderate to severe tumor related pain.

Patients with metastatic solid malignancies and patients with hematologic malignancies with moderate to severe tumor related pain on a stable opioid regimen will be the subjects of this study.

Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

To evaluate the safety (Phase I) of oral Sodium bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain.

To determine the maximum tolerated dose (MTD) of oral sodium bicarbonate capsules for patients with tumor related moderate to severe pain.

Evaluate the efficacy (Phase II) of oral Sodium Bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain.

Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 4 weeks compared to baseline without a corresponding increase in opioid regimen. The response rate with 95% Clopper-Pearson confidence interval will be reported.

Pain will be rated by the participant using a visual assessment scale (VAS) on a 0 to 10 scale. Mild Pain (1-4), Moderate Pain (5-6), Severe Pain (7-10). The change in pain between baseline and 4 weeks after treatment as measured by the VAS will be assessed using two-sided one-sample t-test or Wilcoxon signed-rank test, depending on whether normality assumption holds.

Quality of life will be assessed using the Memorial Symptom Assessment Scale (MSAS) and Brief Pain Inventory (BPI). The change in score between baseline and 4 weeks after treatment will be compared using two-sided one-sample t-test or Wilcoxon signed-rank test, as appropriate.

Reliable Cancer Therapies

H. Lee Moffitt Cancer Center and Research Institute

Digestive System Diseases

Mouth and Tooth Diseases

Head and Neck Neoplasms

Mucositis

Stomatitis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Amino Acids

Glutamine

MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine

MucoLox

Jai Patel, PharmD, BCOP

This study will examine if the administration of prophylactic MucoLox formulation versus sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ± chemotherapy will result in significantly fewer subjects experiencing severe mucositis.

The primary objective of this double-arm, single-blinded, Phase II randomized study is to compare the area under the curve (AUC) for the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) score over a one-month period in subjects receiving the MucoLox formulation versus sodium bicarbonate rinse (as the control) for the prevention of severe mucositis in subjects with head/neck cancer receiving radiation ± chemotherapy. Secondary objectives include comparing the time to OMDQ MTS Q2 \> 2 between the two arms; estimating and comparing opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit; assessing and comparing changes in the remaining OMDQ questions longitudinally throughout study; evaluating and comparing the duration of symptom relief in those who experience any degree of oral mucositis; evaluating and comparing the frequency of delays in \[chemotherapy and/or radiation\] therapy throughout the study period; and summarizing and comparing the prevalence and grade of oral mucositis at each clinic visit. The safety objective is to summarize the rates of potential side effects related to each oral formulation. A total of 60 eligible subjects will be enrolled and randomized in a 1:1 fashion to one of the treatment arms. Subjects on the control arm (sodium bicarbonate) who experience severe mucositis will have the option to crossover to the Mucolox arm for an additional 7 ± 2 days or until day 29 ± 5 days, whichever is longer.

MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Phase II Randomized Trial of an Oral Formulation Containing a Mucoadhesive Polymer Hydrogel Vehicle (MucoLox®) to Mitigate Mucositis Symptoms in Head/Neck Cancer Patients Receiving Radiation ± Chemotherapy

To summarize the rates of potential side effects related to each oral formulation, including but not limited to mouth discomfort, allergic reactions, exacerbation of mucositis symptoms, mouth ulcers, dry mouth, unpleasant taste or dysgeusia. Safety variables include AEs and SAEs related to the study treatment. Adverse events will be evaluated continuously throughout the study. Safety, tolerability, relationship to study treatment, and intensity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

To compare the area under the curve (AUC) for the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) score over a one-month period in subjects receiving the MucoLox formulation versus sodium bicarbonate rinse (as the control) for the prevention of severe mucositis in subjects with head/neck cancer receiving radiation ± chemotherapy

To compare the time to OMDQ MTS Q2 \> 2 between the two arms

To estimate opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5) and compare between the two arms

To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.

To evaluate and compare the duration of symptom relief in those who experience any degree of oral mucositis between the two arms

To evaluate the frequency of delays in \[chemotherapy and/or radiation\] therapy throughout the study period and compare between the two arms.

To summarize the prevalence and grade of oral mucositis at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5), as assessed by the treating investigator using the WHO criteria for grading, and compare between the two arms.

The Generalized McNemar's test will be used to analyze correlation between patient report OMDQ Q2 scores and oral mucositis grading assessed by treating investigator using WHO criteria.

Professional Compounding Centers of America

Atrium Health Levine Cancer Institute

Wake Forest University Health Sciences

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Pharmaceutical Solutions

IV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.

sodium bicarbonate

IV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.

NaCl

Ricardo G Silva, MD

Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, \>18 years old, with a GFR \<60 and \>30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.

Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Barretos Cancer Hospital

Micronutrients

Zinc

The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)

The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)

Zinc Gluconate

Carlo Lajolo, Prof.

Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.

Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.

The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.

The study will be conducted as a single-blind randomized clinical trial (RCT). The population will be divided into two groups, receiving respectively the medical device and a solution based on Sodium Bicarbonate (5 g/L)

The principal investigator will be encharged of generating the allocation sequence, of enrolling the participants and of assigning the interventions to the participants.

The coworkers who will evaluate the onset of OM and its severity will be blinded about the selected product.

Prevention of Oral Mucositis in Head and Neck Cancer.

Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.

Catholic University of the Sacred Heart

Prof.

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

Systemic Chemotherapy + Oral Chemotherapy Group

Arterial catheter infusion chemotherapy plus oral chemotherapy group

Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group

Arterial catheter infusion chemotherapy

Arterial catheter infusion Sodium Bicarbonate

Systemic Chemotherapy

Oral Chemotherapy

Ming Chao

Min Chao

This project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not suitable for the treatment of unresectable gastric cancer. The clinical practice value of resection of gastric cancer can provide high quality evidence-based medical basis for the treatment guidelines of advanced gastric cancer, and explore a new clinical technology with exact curative effect and higher safety.

Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer

A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer

Second Affiliated Hospital, School of Medicine, Zhejiang University

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Acute Coronary Syndrome

Syndrome

Respiratory Insufficiency

Myocardial Infarction

Infarction

Lung Neoplasms

Angina Pectoris

Angina, Unstable

Arrhythmias, Cardiac

Pneumonia

Thromboembolism

Airway Obstruction

Ischemia

Necrosis

Lung Diseases

Respiratory Tract Diseases

Coronary Artery Disease

Myocardial Ischemia

Heart Diseases

Respiration Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Chest Pain

Thrombosis

Embolism

Embolism and Thrombosis

Acute Graft Versus Host Disease

Normal saline sprayed into stent/airway tubes then suctioned out through bronchoscope.

Sodium bicarbonate sprayed into stent/airway tubes then suctioned out through bronchoscope.

Normal saline administered in stent/airway tubes under direct visualization via the bronchoscope.

Normal Saline

4.2% bicarbonate solution mixed with equal volume of sterile water administered into stent/airway tubes under direct visualization via the bronchoscope.

Carlos A. Jimenez, MD

The goal of this clinical research study is to compare the effects of sodium bicarbonate to normal saline when used for clearing mucus blockage in patients with airway stents.

Study Agents:

Sodium bicarbonate is also called baking soda. In this study it will be mixed with water.

Normal saline is a salt water solution.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. The study doctor will use either sodium bicarbonate or normal saline during your bronchoscopy to clear mucus from your stent:

* If you are in Group 1, the study doctor will use sodium bicarbonate. The amount of sodium bicarbonate in the solution will be the same for all patients in Group 1.
* If you are in Group 2, the study doctor will use normal saline.

You will have an equal chance of being assigned to either group. Neither you nor the study staff can choose the group you will be in, and neither you nor your doctor will know if you are receiving sodium bicarbonate or normal saline. However, if needed for your safety, the study staff will be able to find out what you are receiving.

If you have more than 1 stent, only 1 of your stents will be checked for clearance of mucus in this study. However, all stents will be cleared of mucus if needed.

As part of your standard of care, you will have photographs and videos taken before and after your bronchoscopy. You will sign a separate consent form for your bronchoscopy. Your complete medical history will also be recorded.

For the bronchoscopy, you will be given drugs to help you relax, and then a local anesthetic will be sprayed into your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your airway tubes.

If you are in Group 1, a small amount of sodium bicarbonate will be sprayed into your stent/airway tubes and then suctioned out through the bronchoscope.

If you are in Group 2, a small amount of normal saline will be sprayed into your stent/airway tubes and then suctioned out through the bronchoscope.

Next, 3 study doctors will check how well the mucus in your stent was cleared. If the study doctors think not enough mucus has been cleared from your stent, you will "crossover" into the other study group and receive the other agent to clear your mucus.

Length of Study:

Your participation on the study will be over after you have completed the follow-up visits.

Follow-Up:

At about 7 days, and then again 30 days after your bronchoscopy, you will come to the clinic for a follow-up visit. The following procedures will be performed:

* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
* You will also be asked about any side effects you may be having.

This is an investigational study. Normal saline and sodium bicarbonate are agents used in bronchoscopies performed in patients with airway stents as standard of care. The comparison of sodium bicarbonate to normal saline to clear mucus from airway stents is considered investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Clearance Of Mucus In Stents (COMIS)

Response/efficacy of sodium bicarbonate versus normal saline in airway stents graded using scale. Percentage of obstruction resolution (relative to initial stent lumen obstruction by mucus): Good response 51-75% clearance; and Excellent 76 - 100% clearance. The Mantel-Haenszel chi-square test stratified by degree of lumen obstruction at study enrollment used to compare response (good or excellent obstruction resolution) rates between treatment arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain	NCT01846429	Tumor Cancer Pain Malignant Solid... Unresectable Ma... Hematologic Mal... Multiple Myelom... Lymphoma Neoplasm Metast...	Sodium Bicarbon...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer	NCT03461354	Mucositis Oral Head and Neck C...	MucoLox Sodium Bicarbon...	18 Years -	Wake Forest University Health Sciences
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate	NCT00540904	Radiographic Co...	sodium bicarbon... NaCl	18 Years -	Barretos Cancer Hospital
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain	NCT01846429	Tumor Cancer Pain Malignant Solid... Unresectable Ma... Hematologic Mal... Multiple Myelom... Lymphoma Neoplasm Metast...	Sodium Bicarbon...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Prevention of Oral Mucositis in Head and Neck Cancer.	NCT05853692	Oral Mucositis	Zinc Gluconate Sodium Bicarbon...	18 Years -	Catholic University of the Sacred Heart
Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer	NCT03822130	Successful Conv... Unresectable Ga...	Arterial cathet... Sodium Bicarbon... Systemic Chemot... Oral Chemothera...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Clearance Of Mucus In Stents (COMIS)	NCT01370278	Lung Neoplasms Respiratory Fai... Pneumonia Acute Coronary ... Unstable Angina Myocardial Infa... Cardiac Arrhyth... Thromboembolic ...	Normal Saline Sodium Bicarbon...	18 Years -	M.D. Anderson Cancer Center

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