Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

In addition to the standard care, subject will consume a 5-day fasting mimicking diet.

Subjects will receive the standard care and no dietary changes.

Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.

Fasting Mimicking Diet

6 cycles of standard chemotherapy for the gynecologic malignancy.

Chemotherapy

Min Wei, PhD

Jonathan D Boone, MD

Jonathan D Boone

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.

The study focuses on the chemotherapy of gynecologic malignancies.

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies

The NFOSI-18 questionnaire allows for a uniform assessment of health-related quality of life through an 18-question (5-point Likert-type scale) survey including four subscale domains: Disease-Related Symptoms - Physical, Disease-Related Symptoms - Emotional, Treatment Side Effects. and Function/Well-Being. To calculate subscale scores, sum the item scores within each domain. Higher subscale scores indicate more significant symptom burden or impact. The total score is obtained by summing all 18 item scores. A higher total score reflects more severe symptoms overall.

The ability to adhere to a 5-day fasting mimicking diet.

Changes in weight, skeletal muscle mass, body fat percentage by the Inbody(R) Body Composition Analyzer.

Change in blood insulin like growth factor 1 level.

Change in blood C reactive protein level.

Deviation from the planned chemotherapy regimen.

Rate of Adverse effects associated with chemotherapy

University of Tennessee Medical Center

L-Nutra Inc

Uterine Cervical Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Vaginal Cancer

Vulvar Cancer

20 patients greater than or equal to 65 years of age

Mahesh Varia, MD, ChB

Noam VanderWalde, MD

The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.

There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues. Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.

Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers

Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers

Patient-reported acute grade 3-5 radiation related toxicities will be based on the PRO-CTCAE questionnaire during and 4-8 weeks post radiation therapy and at 6 months.

Provider-reported grade 3-5 acute radiation related toxicities will be based on the CTCAE (Common Toxicity Criteria for Adverse Effects) v4.03 during and 4-8 weeks post radiation therapy

Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.

Poor adherence to treatment is defined by at least one of the following:

1. \> 3 day treatment delay secondary to treatment related toxicity during radiation therapy.
2. Hospitalization secondary to treatment related toxicity during or up to 4-8 weeks post radiation therapy.
3. Unplanned dose reductions in either radiation or concurrent chemotherapy secondary to treatment related toxicity during radiation therapy
4. Unplanned change in concurrent chemotherapy regimen secondary to treatment related toxicity during radiation therapy.

UNC Lineberger Comprehensive Cancer Center

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Thrombopoietin

Platelet-pheresis

Saroj Vadhan-Raj, MD

A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin

rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy Receiving Carboplatin

Pharmacia

LifeCell

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

Infertility

Quality of Life

Participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022.

Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility

Fertility sparing surgery

NAZLI ALBAYRAK, MD

FSS which aims to preserve a woman's fertility while still effectively treating the cancer, has become an increasingly popular option for young women diagnosed with these types of cancers. It is important to assess how FSS affects a woman's reproductive health, sexual function, psychological well-being, and overall quality of life. This research aims to provide valuable insights into the long-term effects of FSS on a woman's life, and can help healthcare providers make informed decisions about the best treatment options for their patients.

This is a prospective cohort study that aims to evaluate the infertility and pregnancy outcomes, as well as the quality of life of women who underwent fertility-sparing surgery for gynecological malignancies. The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods. Participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022. Women who have undergone total hysterectomy, bilateral salpingo-oophorectomy, or adjuvant oncological treatment were excluded from the study. Participants were contacted by phone and asked to complete questionnaires to assess their quality of life using the WHOQoL-BREF and FertiQoL scales.

The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods.

Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

The Evaluation of Infertility and Pregnancy Outcomes, as Well as the Assessment of Quality of Life Using WHOQoL and FertiQoL, in Cases of Gynecological Malignancies That Have Undergone Fertility-sparing Surgery(FSS)

Incidence and rate of patients getting pregnant after FSS

Rate of patients referring to IVF clinic after FSS

% of patients' satisfaction via Quality of life after the surgery, and decision-regret analysis regarding to fertility sparing by the validated questionnaires

Acibadem University

PGY-4 Ob/Gyn resident, MD

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Respiratory Aspiration

Pain

Mindful Movement and Breathing program implemented in a hospital room or clinic room three times by a yoga instructor: prior to surgery, one day and two days after surgery.

Participate Mindful Movement and Breathing program with an experienced yoga instructor. All movements can be done while in a bed (e.g. turning head, shrugging shoulders, bending knees, etc). Each session lasts approximately 15 minutes.

Mindful Movement and Breathing program

Collected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery).

Questionnaire administration

Conducted by nurse and study coordinator prior to surgery and two days after surgery to assess mobility. Will ask patient to turn, sit, stand and walk as they are able.

The Observer Mobility Scale

Conducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used.

Volumetric Incentive Spirometry

Suzanne Danhauer, PhD

The purpose of this clinical trial is to understand if women undergoing surgery for a suspected gynecologic malignancy are interested in participating in a Mindful Movement and Breathing program and what the effects of this program are on women and the surgery-related symptoms they experience. Mindful Movement and Breathing programs may be effective for easing distress, post-surgical pain, and other symptoms of surgical procedures.

Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

The proportion of participants who participated in all YST sessions and those who completed all assessments will be computed and compared to those with incomplete data by demographic characteristics. We will model the relationship between adherence and baseline scores of the measures, as well as change in scores. We will also calculate the proportions and 95% confidence intervals of the items that measure program evaluation and intervention to the Clinical Studies Coordinator, nurses and yoga instructor.

Measured using Immediate Effect Visual Analog Scales (VAS) of pain and distress and percent change in inspiratory capacity as assessed with a Volumetric Incentive Spirometer. Assessed for each measure by day using a paired t-test and overall using a mixed effects model on the pre-post change in the measure over time.

means and standard deviations of the measures will be calculated to inform sample size calculations for a future study, and to provide descriptive statistics of the sample population.

Wake Forest University Health Sciences

Digestive System Diseases

Urinary Incontinence

Fecal Incontinence

Enuresis

Lower Urinary Tract Symptoms

Urological Manifestations

Karen L Noblett, M.D.

This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.

Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, is directly affected by gynecologic malignancies and the surgical and medical management of those malignancies. Increased risk of injury to the urinary tract is a recognized complication of surgical and medical therapy of gynecologic malignancies. To date, only a few studies have looked at the incidence of lower urinary tract symptoms at the time of diagnosis of gynecologic malignancy and prior to treatment, and there have been no published studies describing the incidence of sexual dysfunction at the time of diagnosis and prior to therapy of gynecologic malignancies. However, sexual dysfunction has been described in patients with urinary incontinence and pelvic organ prolapse and following surgery for incontinence and pelvic organ prolapse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies	NCT06376604	Cancer, Ovarian Chemotherapy Ef... Calorie Deficie... Fasting, Interm...	Fasting Mimicki... Chemotherapy	35 Years - 70 Years	L-Nutra Inc
Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers	NCT02003430	Non-ovarian Gyn...		18 Years -	UNC Lineberger Comprehensive Cancer Center
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin	NCT00038012	Neoplasms, Gyne...	Thrombopoietin Platelet-pheres... Carboplatin	15 Years -	M.D. Anderson Cancer Center
Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients	NCT05823194	Fertility Disor... Gynecologic Can...	Fertility spari...	20 Years - 49 Years	Acibadem University
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies	NCT06376604	Cancer, Ovarian Chemotherapy Ef... Calorie Deficie... Fasting, Interm...	Fasting Mimicki... Chemotherapy	35 Years - 70 Years	L-Nutra Inc
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery	NCT01593657	Gynecologic Mal... Abdominal Surge... Pain Psychological D... Lung Function Surgical Compli...	Mindful Movemen... Questionnaire a... The Observer Mo... Volumetric Ince...	18 Years -	Wake Forest University Health Sciences
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery	NCT01593657	Gynecologic Mal... Abdominal Surge... Pain Psychological D... Lung Function Surgical Compli...	Mindful Movemen... Questionnaire a... The Observer Mo... Volumetric Ince...	18 Years -	Wake Forest University Health Sciences
Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers	NCT02003430	Non-ovarian Gyn...		18 Years -	UNC Lineberger Comprehensive Cancer Center
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies	NCT06376604	Cancer, Ovarian Chemotherapy Ef... Calorie Deficie... Fasting, Interm...	Fasting Mimicki... Chemotherapy	35 Years - 70 Years	L-Nutra Inc
Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management	NCT00580697	Lower Urinary T... Gynecologic Mal...		18 Years -	University of California, Irvine

Spots Global Cancer Trial Database for gynecologic malignancy