Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Antineoplastic Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Herbal and Botanical

Turmeric extract

Cisplatin

Curcumin

Antioxidants

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Turmeric

Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Curcugreen (BCM95) 2000mg daily (each 6h)

Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Placebo Capsules 500mg 2000mg daily (each 6h)

BCM-95® (CURCUGREEN®) is a 100 percent pure extract of turmeric with enhanced bio-availability and bio-efficacy. Its powerful health-promoting benefits are derived from the colorful and aromatic qualities of the Indian spice

Placebo oral tablet

Jose A Carreño, Md

Determine the efficacy and safety of turmeric in the treatment of patients with advanced cervical cancer. Efficacy will be determined through radiological and histopathological criteria through the rate of response to treatment, duration of response, the rate of objective response and disease control, as well as overall survival and disease-free survival. The safety of therapy will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) classification

A placebo-controlled phase II clinical trial will be developed in patients with advanced cervical cancer who have an indication for radiotherapy. Those who accept to participate will receive the standard treatment with established chemo-radiation and will be randomized in two arms, the experimental will receive 500mg of the commercial presentation (curcugreen) c / 6h VO x 16 weeks and the control arm will receive placebo. The operative hypotheses are: the addition of curcumin to the treatment improves the cumulative probability of 3-year overall survival by 20% and improves the treatment response rate. The statistical analysis will include a Cox proportional hazards model and the results of the groups will be compared with the Student's T-test or ANOVA. This research hopes to collect tissue samples for future research that allows the identification of predictive biomarkers and disease prognoses.

Phase II clinical trial, randomized and placebo controlled

Curcumin in Advanced Cervical Cancer

Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer

Common Terminology Criteria for Adverse Events (CTCAE)

Instituto Nacional de Cancerologia, Columbia

Symptoms and General Pathology

Behaviors and Mental Disorders

Inflammation

Quality of Life

Concumption of 3 servings of the fermented dairy beverage a day, during oncological treatment.

Consumption of 3 servings of the placebo dairy beverage a day, during oncological treatment.

Placebo dairy beverage (placebo) is a sweetened dairy beverage.

Placebo dairy beverage

Lucely Cetina Pérez, MD, PhD

Many cancer survivors have increased risk of intestinal damage, affecting the quality of life of patients. The role of intestinal microbiota on the development of gastrointestinal toxicity and radiation enteritis has been described in cervical cancer patients that received pelvic RT. In this project we investigated the effect that a fermented dairy beverage (Yakult) may have in the modulation of inflammation and consequently of gastrointestinal toxicity in locally advanced cervical cancer (LACC) patients treated with concomitant chemo-radiotherapy (CRT).

Globally, many cancer survivors have undergone radiotherapy (RT) to pelvic tumors, this confers an increased risk of intestinal damage, affecting the quality of life of patients. The role of intestinal microbiota on the development of gastrointestinal toxicity and radiation enteritis has been described in cervical cancer patients that received pelvic RT. In this project we investigated the effect that a fermented dairy beverage (Yakult) may have in the modulation of inflammation and consequently of gastrointestinal toxicity in locally advanced cervical cancer (LACC) patients treated with concomitant chemo-radiotherapy (CRT).

In Mexico, the incidence of cervical cancer is 23 cases in 100,000 women (2015, Secretaría de Salud). In the Mexican National Cancer Institute (Instituto Nacional de Cancerología; INCan), 80% of patients arrive at locally advanced stages (IB2-IVA), the standard treatment is based on CRT. Gastrointestinal symptoms experienced by patients that receive pelvic RT define the pelvic radiation disease (PRD). Acute PRD is the result of cell death in the crypt epithelium and an acute inflammatory response in the lamina propria, which results in an insufficient replacement of the villi, rupture and inflammation of the mucosal barrier. Symptoms develop in 60-80% of patients. These include nausea, diarrhea, tenesmus, abdominal pain, urgency, anorexia, bleeding and fatigue; these are dose-limiting symptoms and affect the patients' quality of life.

A recent study analyzed the microbiota of LACC patients and found that patients that develop PRD during treatment with CRT possess a different microbiota to those patients that do not develop severe gastrointestinal toxicity. Evidence points to the critical role that the microbiota and intestinal inflammation play for the development of PRD in LACC patients. Therefore, an optimal intervention that modulates the microbiota is essential. We aimed to investigate the effect that a dairy beverage fermented with the probiotic Lactobacillus casei Shirota may have on intestinal and systemic inflammation, and consequently gastrointestinal symptoms and quality of life in women with LACC, undergoing CRT.

METHODS. This study was a double blind, placebo-controlled trial for Stage IIB cervical cancer patients that underwent CRT. The intervention group consumed of 3 servings of the fermented dairy beverage (Yakult) a day. The control group consumed 3 servings of the placebo beverage (with the same organoleptic qualities of Yakult). Clinical toxicity was analyzed with the Common Toxicity Criteria Version 2. Quality of Life score was measured with the QLQC 30 EORTC questionnaire. Fecal calprotectin was quantified to determine intestinal inflammation. Pro- and anti-inflammatory cytokines were quantified in blood samples to determine systemic inflammation.

Use of a Fermented Dairy Beverage in Cervical Cancer Patients Undergoing Concurrent Chemoradiation Therapy

Phase II Randomized, Double Blind Study of Probiotics in Patients With Cervical Cancer in Clinical Stages IIB Undergoing Concurrent Chemotherapy and Radiation Therapy

Toxicity was analyzed with the Common Toxicity Criteria Version 2.

A grading (severity) scale is provided for each adverse event (AE) term. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:

Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.

Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.

Grade 4 Life-threatening consequences; urgent intervention indicated.

Grade 5 Death related to AE.

It was measured with the EORTC QLQ-C30 V2.

Th1, Th2, Th17 and IL-10 citokines were quantified in blood samples to determine systemic inflammation using immune assay ELISA.

Yakult Honsha Co., LTD

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Instituto Nacional de Perinatologia

National Institute of Cancerología

Principal investigator

The patient will receive Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy.

Whole pelvis radiation therapy will be delivered according to institutional standard of care.

SBRT is delivered with 5 fractions of 5.5-8 Gy prescribed to the high-risk CTV, with dose constraints identical to those for high dose rate, volume-directed brachytherapy. The patient will undergo arc therapy with a minimum of two arcs. On-line kV CBCT will be used to verify the isocenter prior to each arc delivery. Patients will be resimulated for SBRT boost planning.

Radiation Therapy

Loren Mell, MD

The purpose of this study is to find out whether patients with cervical cancer treated with about a new radiation technique called "stereotactic body radiotherapy (SBRT) have less stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy radiation, metal hardware is placed through the vagina and into the uterus, which can cause pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not require the insertion of any metal hardware.

This is a Phase II, single-center, single-arm, study of Stereotactic Body Radiotherapy boost for stage IB-IVB cervical cancer.

The primary objective of the study is to test the hypothesis that stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

Study participants will be recruited within the UCSD Health System. For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study. The investigator will approach the subject and offer participation in the trial. If the patient chooses to participate, they will undergo pretreatment evaluations to determine if they are a good candidate to participate further in the study. Depending on when the patient last had these tests and procedures performed, some of them may not need to be repeated.

Upon confirmation of all eligibility criteria, the subject will be enrolled. Each enrolled subject will receive radiation therapy consisting of 30 to 35 treatments. The patient will first undergo Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks, followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy. Concurrent chemotherapy may be given with radiation therapy according to the discretion of the treating oncology team. No chemotherapy will be given during the SBRT phase of treatment. During radiation therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and evaluations for stress, anxiety, and pain.

Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer

To quantify treatment-related symptoms of post traumatic stress to determine if stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity following SBRT.

To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30).

To measure health-related quality of life based on the cervical cancer module (CX24).

To quantify intrafraction cervical motion using cone beam computed tomography.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Curcumin in Advanced Cervical Cancer	NCT04294836	Cervical Cancer...	Curcumin Placebo oral ta...	18 Years - 70 Years	Instituto Nacional de Cancerologia, Columbia
Use of a Fermented Dairy Beverage in Cervical Cancer Patients Undergoing Concurrent Chemoradiation Therapy	NCT05736315	Cervical Cancer...	Placebo dairy b...	18 Years - 70 Years	National Institute of Cancerología
Curcumin in Advanced Cervical Cancer	NCT04294836	Cervical Cancer...	Curcumin Placebo oral ta...	18 Years - 70 Years	Instituto Nacional de Cancerologia, Columbia
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for cervical cancer, stage iib