Completed

Oxytocin Nasal Spray for Hypothalamic Obesity Weight Loss in Brain Tumor Patients

Study Aim

This study aims to evaluate if an 8-week treatment with Oxytocin Nasal Spray, compared to a placebo, can promote weight loss in individuals aged 10 to 35 years with brain tumors and hypothalamic obesity syndrome.

What is being tested

Syntocinon

+ Placebo (for Syntocinon)

Drug

Who is being recruted

Congenital Abnormalities+16

+ Urogenital Diseases

+ Craniopharyngioma

From 10 to 35 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: October 2016

See protocol details

Summary

Principal SponsorShana McCormack, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2016

Actual date on which the first participant was enrolled.

This study focuses on children, adolescents, and adults who have brain tumors and a condition called Hypothalamic Obesity. The main goal is to test if a hormone called oxytocin, given through a nasal spray, can help with weight loss compared to a placebo, a substance that has no therapeutic effect. This research is important as it aims to find a new treatment approach for weight loss in individuals with this specific condition, potentially improving their quality of life and addressing an unmet need. The study consists of two parts. In the first part, participants will receive either oxytocin or a placebo. In the second part, participants will switch to receive the other treatment. During the study visits, participants will undergo blood tests, physical exams, metabolic testing, an MRI scan, and will complete some surveys and questionnaires. The primary outcome measured is weight loss, specifically the difference in weight after treatment between the oxytocin and placebo periods.

Official TitleIntranasal Oxytocin to Promote Weight Loss in Children, Adolescents, and Adults With Brain Tumors and Hypothalamic Obesity Syndrome

NCT02849743

Principal SponsorShana McCormack, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesCraniopharyngiomaEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersGonadal DysgenesisHypogonadismCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueDisorders of Sex DevelopmentUrogenital AbnormalitiesNeuroectodermal TumorsSexual InfantilismFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

10 inclusion criteria required to participate

Proficient in English.

Males or females age 10 to 35 years, inclusive.

Weight ≥ 51 kg.

Girls must have a negative urine/serum pregnancy test and post-menarchal girls must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.

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18 exclusion criteria prevent from participating

Diabetes insipidus without intact thirst mechanism (i.e., history that participant is not thirsty when hypernatremic and/or continues to be thirsty when hyponatremic, by participant/family and/or practitioner report and medical records) and/or "brittle" diabetes insipidus, defined as requiring >1 admission in the past year and/or any admission within the previous 3 months.

Diabetes mellitus requiring insulin or insulin secretagogue. Laboratory values: HgbA1c ≥8%

Cardiovascular condition, as defined as any of the following: i) abnormal blood pressure, defined as <3%ile or >97%ile for age, sex and height; ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and/or cardiomyopathy; iv) prolonged QTc interval (QTc > 460 msec), and/or long QT syndrome phenotype and/or positive genotype for long QT syndrome pathogenic mutations.

Concurrent use of medications known to prolong QTc interval and pose high risk for Torsades de Pointes (TdP) according to the current information available (www.crediblemeds.org). Concomitant medications will be assessed by IDS pharmacist, in collaboration with study cardiologist, if additional clarification is needed. In addition, we require that potential participants be on a stable dose for at least 2 months of any medication with the potential to alter cardiac rhythm to ensure the screening ECG reflects steady-state physiology.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Week 0 to Week 7: Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) Week 8 to Week 11: Washout Week 12 to Week 20: Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)

Group II

Experimental

Week 0 to Week 7: Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) Week 8 to Week 11: Washout Week 12 to Week 20: Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) \*Dose Escalation, as appropriate, at 2 Weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Children's Hospital of Philadelphia

Philadelphia, United StatesOpen Children's Hospital of Philadelphia in Google Maps

CompletedOne Study Center