Neoplasms

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Adrenal Insufficiency

Neoplastic Processes

Adrenal Gland Diseases

Endocrine System Diseases

Secondary Adrenal Insufficiency

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Glucocorticoids

Racepinephrine

Epinephryl borate

education of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule

education and drug adjustement

Intermittent Ramadan fasting was associated with a risk of complications in patients with adrenal insufficiency. A risk stratification with recommendations (lifestyle and drug adjustment) for fasting in these patients has been recently published. So, this prospective interventional study was carried out to evaluated these recommendations. Patients with secondary adrenal insufficiency and willing to fast Ramadan were included. Before Ramadan, patients underwent a clinical examination and were educated for lifestyle measures and the schedule of glucocorticoid replacement therapy was adjusted. The occurrence of complications and the number of fasted days during the month of Ramadan 2023 were reported and compared with those of Ramadan 2022.

Intermittent fasting during the month of Ramadan is one of the five pillars of Islam and a sacred ritual for Muslims. Patients with chronic diseases seek advice from their physician and insist on fasting. A former study showed that 76.7% of adrenal insufficiency patients were exempted from fasting and 50.5% of them fasted against the advice of their physician. Few studies have assessed the risk of complications in adrenal insufficiency patients. The most frequently reported complications were asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%). Hypoglycaemia was detected by 24 hour-continuous glucose monitoring in 10% of fasting patients with secondary adrenal insufficiency (SAI). These complications were more frequent in patients with insufficient knowledge of the disease. A literature review was published 2021 and a risk stratification of patients with adrenal insufficiency and recommendations for patient education and therapeutic adjustment were proposed. However, no study has evaluated the effect of these measures on Ramadan fasting in SAI.

The objectives were to:

1. compare the number of fasted days and the prevalence of complications during Ramadan fasting before (2022) and after therapeutic education and treatment adjustment (2023) in patients with SAI.
2. determine the factors associated with complications during Ramadan fasting in SAI.

Methods:

Before the month of Ramadan 2023, patients meeting the inclusion criteria were enrolled. All patients signed a written informed consent.

During the first visit, the following data were recorded:

* gender, age, medical and surgical history, current treatments, medication schedule, the 2022 fast (number of fasted days, complications (type, days, time, break of the fast for a complication)).
* weight, height, lying and standing blood pressure.
* Some data were taken from the medical file: other affected pituitary axes, etiology of the SAI, results of the insulin hypoglycaemia test if performed (baseline cortisol, peak level, peak time, area under the curve), plasma creatinine.

Subsequently, patient education (the particularities of the disease, the risks and lifestyle measures) and therapeutic adjustments were performed according to the recommendations published by Chihaoui et al in Endocrine, 2021.

Throughout the month of Ramadan 2023, patients filled in forms indicating for the fasted days: dinner time, shour time, sleep time, unusual physical activity, treatment schedule, occurrence of complications: type, time, break of the fast for a complication.

Throughout the study, regular telephone contact with one of the investigators was performed for any additional information, advice or therapeutic adjustment.

before and after education and drug adjustement

Ramadan Fasting in Secondary Adrenal Insufficiency Patients

Data can be shared on reasonable request.

Hopital La Rabta

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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

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

Fatigue

Herbal and Botanical

Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.

Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

12 weeks of time-restricted eating (10-hour window)

Time-restricted eating

Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks

Healthy lifestyle education

Amber Kleckner, PhD

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism.

The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial

To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.

FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long, and a higher score indicates less fatigue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ramadan Fasting in Secondary Adrenal Insufficiency Patients	NCT05827965	Secondary Adren... Fasting, Interm...	education and d...	18 Years -	Hopital La Rabta
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
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
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
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue	NCT05256888	Neoplasms Therapy Fatigue Diet Therapy Time Survivorship Fasting, Interm...	Time-restricted... Healthy lifesty...	18 Years -	University of Maryland, Baltimore

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