Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Inflammation

Uterine Cervical Neoplasms

Pelvic Inflammatory Disease

Pelvic Infection

Communicable Diseases

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

Adnexal Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Micronutrients

Other Dietary Supplements

Vitamins

Trace Elements

Antioxidants

Protective Agents

Omega 3 Fatty Acid

Dietary intervention providing:

Energy: 28-31 kcal/kg/day. Protein: 20-30%. Fat: 30-40%. Carbohydrates: 40-50%. The diet will be individualized according to the patients' comorbidities (obesity, type 2 diabetes, hypertension, renal insufficiency).

This group will include the consumption of foods that contain immune modulating nutrients:

Omega-3 fatty acids, antioxidants, soluble fiber, probiotics. The recommendation to include these foods will be made according to the patients' access to food in their home area.

Dietary intervention providing:

Energy: 28-31 kcal/kg/day. Protein: 20%. Fat: 20%. Carbohydrates: 60%. Diet will have lactose restriction, fiber restriction and fat restriction.

Diet will include foods rich in omega-3 fatty acids.

Omega-3 fatty acids

Diet will include foods rich in antioxidant vitamins, trace elements, and polyphenols.

Diet will include foods rich in soluble fiber.

Soluble fiber

Diet will include foods rich in probiotics.

Probiotics

Diet will be restricted to 5g lactose/day

Lactose restriction

Fiber restriction

Diet will be restricted to 20% total energy intake

Fat restriction

Lucely Cetina, MD, MSc

During radiation therapy (RT) to pelvic tumors, the small intestine, colon and rectum are inevitably included in the radiation field and are healthy tissues that suffer damage as an adverse effect. Pelvic radiation disease (PRD) is the group of gastrointestinal symptoms experienced by patients that receive pelvic radiation. Intestinal inflammation, tissue damage, oxidative stress and tumor metabolism lead the patient to a catabolic state associated with an increase in energy demands. Also, the painful abdominal symptoms restrict the patients' food intake, leading the patients that develop PRD to an increased risk to develop protein-energy malnutrition and micronutrient deficiencies, all of which affect the patients' quality of life. Studies developed in patients with inflammatory bowel disease have suggested that probiotics may have an anti-inflammatory effect in the intestine. In addition, micronutrients and trace elements provide antioxidant capacity and exert immune-modulating effects during periods of intestinal inflammation. Thus, probiotics and immune-modulating nutrients may provide a means to diminish intestinal inflammation and symptoms associated with PRD. In this project the investigators propose that the nutritional management of cervical cancer patients be based on an anti-inflammatory diet, taking into account the nutritional status, age, comorbidities that the patient may present and symptoms developed during treatment. The nutritional intervention will include food rich in immune-modulating nutrients: omega-3 fatty acids, soluble fiber, antioxidants and polyphenols, and probiotics.

Cervical cancer is the second most frequent cancer in Mexican women, representing 16.9% of the total female population. At the National Cancer Institute of Mexico (Instituto Nacional de Cancerología), 80% cervical cancer patients arrive at locally advanced stages (IB2-IVA). Standard treatment for these stages is based on concomitant chemo-radiotherapy. During radiation therapy (RT) to pelvic tumors, the small intestine, colon and rectum are inevitably included in the radiation field and are healthy tissues that suffer damage as an adverse effect. Pelvic radiation disease (PRD) is the group of gastrointestinal symptoms experienced by patients that receive pelvic radiation. Acute PRD occurs during the time of treatment in 60 to 80% patients, symptoms include nausea, diarrhea, tenesmus, abdominal pain, urgency, mucositis, anorexia, bleeding and fatigue; these symptoms limit cancer treatment and affect the patients' quality of life. Chronic PRD is a progressive condition and a problem for cervical cancer survivors, symptoms include altered intestinal traffic, altered intestinal motility and nutrient malabsorption. The intestinal immune system plays an important role in the development of PRD and the secondary effects of RT. Intestinal inflammation, tissue damage, oxidative stress and tumor metabolism lead the patient to a catabolic state associated with an increase in energy demands. Also, the painful abdominal symptoms restrict the patients' food intake, leading the patients that develop PRD to an increased risk to develop protein-energy malnutrition and micronutrient deficiencies, all of which affect the patients' quality of life. Among some of the nutritional intervention assays for patients with PRD, some have described that a low residue diet, restricted in fat (20-25%), lactose (5g) and fiber (20g), reduces the frequency and severity of diarrhea; however, this dietary intervention does not prevent weight loss or malnutrition in patients. Furthermore, low residue diets limit the beneficial effect of dietary fiber and fatty acids that may aid in the inflammatory response. Likewise, patients with inflammatory bowel disease (IBD) develop similar symptoms to PRD. Studies developed in these patients have suggested that probiotics may have an anti-inflammatory effect in the intestine. In addition, micronutrients and trace elements provide antioxidant capacity and exert immune-modulating effects during periods of intestinal inflammation. Thus, probiotics and immune-modulating nutrients may provide a means to diminish intestinal inflammation and symptoms associated with PRD. In this project the investigators propose that the nutritional management of cervical cancer patients be based on an anti-inflammatory diet, taking into account the nutritional status, age, comorbidities that the patient may present and symptoms developed during treatment. The individualized energy requirements and nutrient proportions for patients without comorbidities, and for patients with comorbidities such as obesity, type 2 diabetes, hypertension and renal dysfunction, will be calculated according to the recommendations derived from the Consensus of Nutrition in patients with cancer treated with chemo-radiotherapy to the abdominopelvic area. Furthermore, the nutritional intervention will include food rich in immune-modulating nutrients: omega-3 fatty acids, soluble fiber, antioxidants and polyphenols, and probiotics. Because the low residue diet is routinely used for patients that receive pelvic radiation in other institutions, the anti-inflammatory nutritional intervention will be compared with the low residue diet.

An open controlled randomized clinical trial will be performed on women with locally advanced cervical cancer. Candidates will be randomly assigned to one of the two dietary interventions. Experimental group will receive an anti-inflammatory diet with an energy intake of 28-31 kcal/kg/day, based on 30-40% fat, 20% protein, and 40-50% carbohydrates, the diet will include foods rich in omega-3 fatty acids, soluble fiber, antioxidants and polyphenols, and probiotics. The control group will receive a low residue diet with 28-91 kcal/kg/day, based on 20% fat, 20% protein, and 60% carbohydrates, with no more than 20g fiber and 5g of lactose. In both groups, before, during and after cancer treatment, a thorough nutritional evaluation will be performed, gastrointestinal toxicity will be assessed, and serum cytokine levels and fecal calprotectin and lactoferrin levels will be determined to establish the local and systemic inflammatory response. The quality of life of patients will also be assessed before and after treatment.

Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer

Effect of an Anti-inflammatory Diet on the Nutritional Status and Cytokine Expression of Patients With Locally Advanced Cervical Cancer: A Randomized Clinical Trial

Determination of serum IFN-g using immune assay ELISA

Measurement of fecal calprotectin using immune assay ELISA

Evaluation of the severity of gastrointestinal symptoms according to the Common Toxicity Criteria for Adverse Events (CTCAE v4).

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.

Quality of life questionnaire developed and validated for cancer patients (EORTC QLQ-C30 v3, in spanish) will be applied, and the change in summary score will be evaluated.

National Institute of Cancerología

Rare Diseases

Carcinoma

Endometriosis

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Acute Graft Versus Host Disease

Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.

Quality-of-Life Assessment

Questionnaire Administration

Undergo proton or intensity modulated radiation therapy

Radiation Therapy

Clinical Trials Referral Office

Sujay A. Vora, M.D.

Daniel M. Trifiletti, M.D.

Clinical Trials Referra Office

Allison E. Garda, M.D.

This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.

PRIMARY OBJECTIVE:

I. To assess whether proton radiation therapy (RT) is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT) as measured with the Expanded Prostate Cancer Index Composite (EPIC) bowel domain.

SECONDARY OBJECTIVES:

I. To examine the association of bowel and bladder dose-volume histogram (DVH) with bowel and bladder toxicities, respectively.

II. To assess whether urinary toxicity rate is improved with proton RT compared to IMRT as measured with the EPIC urinary domain.

III. To determine if well-being is improved with proton RT compared to IMRT as measured by the Functional Assessment of Cancer Therapy (FACT) cervix domain.

IV. To determine if proton RT reduces grade 2+ hematologic toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 4.0) compared to IMRT.

V. Evaluate progression-free and overall survival between patients receiving proton RT and IMRT.

VI. To determine if proton RT improves overall patient quality of life compared to IMRT using the European Quality of Life Five Dimension (EQ-5D) questionnaire.

EXPLORATORY OBJECTIVES:

I. Evaluate ability to tolerate chemotherapy concurrent or after RT. II. Correlate bone marrow DVH with blood marrow function, and ability to tolerate chemotherapy concurrently or after RT.

III. Correlate bowel and skin DVH with acute toxicity. IV. To evaluate patient-reported gastrointestinal (GI) toxicities as a predictor of assigned treatment regimen, as well as physician-reported GI toxicities as a predictor of assigned treatment regimen.

V. Confirm the validity of the EPIC bowel and urinary domains when referencing the last 7 days.

OUTLINE:

Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers

Will be examined using analysis of covariance.

Will be examined in association with the change in EPIC Bowel and Urinary scores using analysis of covariance, considering the DVH variables as model covariates.

Measured by the Functional Assessment of Cancer Therapy cervix domain. Will be examined using analysis of covariance.

Measured by Common Terminology Criteria for Adverse Events version 4.0. Will be examined using logistic regression.

Will be examined using survival methods. Cumulative probability of progression rates will be calculated treating death as a competing risk. Cox models will be used to assess the association of treatment received (proton RT versus intensity modulated radiation therapy \[IMRT\]).

Will be examined using survival methods. Estimates of OS will be calculated using the Kaplan Meier method. Cox models will be used to assess the association of treatment received (proton RT versus IMRT).

Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be examined using analysis of covariance.

Mayo Clinic

Skin and Connective Tissue Diseases

Nervous System Diseases

Leiomyoma

Myofibroma

Pain

Pelvic Pain

Adenomyosis

Menorrhagia

Metrorrhagia

Neurologic Manifestations

Neoplasms, Connective and Soft Tissue

Hemorrhage

Uterine Hemorrhage

Menstruation Disturbances

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Laparoscopic hysterectomy

Abdominal hysterectomy

Kimberly Kho, MD, MPH

The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.

The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.

Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

1) Patient-centered outcomes composite

1. Quality of life - measured using the Short Form 12 (SF-12v2),
2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ)
3. Body image - measured using the Body Image Scale (BIS)
4. Return to normal activity -measured using the Activities Assessment Scale (AAS)
5. Pain - measured using a 10 point likert scale
6. Productivity - measured using a questionnaire about missed work

Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated

Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer	NCT03994055	Cervical Cancer Uterine Cervica... Pelvic Inflamma... Radiation Toxic... Diet Modificati...	Omega-3 fatty a... Antioxidants Soluble fiber Probiotics Lactose restric... Fiber restricti... Fat restriction	18 Years -	National Institute of Cancerología
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer	NCT04567771	Cervical Carcin... Endometrial Car... Endometriosis Pelvic Inflamma...	Quality-of-Life... Questionnaire A... Radiation Thera...	18 Years -	Mayo Clinic
Surgical Success After Laparoscopic vs Abdominal Hysterectomy	NCT01793584	Metrorrhagia Menorrhagia Leiomyoma Adenomyosis Pelvic Pain Endometriosis Pelvic Inflamma...	Laparoscopic hy... Abdominal hyste...	18 Years - 80 Years	University of Texas Southwestern Medical Center
Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer	NCT03994055	Cervical Cancer Uterine Cervica... Pelvic Inflamma... Radiation Toxic... Diet Modificati...	Omega-3 fatty a... Antioxidants Soluble fiber Probiotics Lactose restric... Fiber restricti... Fat restriction	18 Years -	National Institute of Cancerología
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer	NCT04567771	Cervical Carcin... Endometrial Car... Endometriosis Pelvic Inflamma...	Quality-of-Life... Questionnaire A... Radiation Thera...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for pelvic inflammatory disease