The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management

The Control group will receive routine care

Chemotherapy Effect

Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management

Multimedia education, booklet Providence and tele-nursing follow-up

Indus Children Cancer Hospital Karachi

Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy

Depression (D) and anxiety (A) and stress(S) will be outcome variable. They will be identified by using DASS-21 Scale. The use of DASS-21 Scale is evident in Pakistan . There are 21 questions in this scale equally divided in to three parts having seven questions for Depression, Anxiety and stress respectively. Each question have four level of measurement 0,1, 2 and 3, represent past week experiences. 0 means not applicable to person, 1 means applicable to some degree or sometime, 2 means applicable to considerable degree or good part of time, 3 means applicable to person very much or most of the time. Each question is separate for Stress(s), Anxiety (a) and Depression (d).

Nomi Waqas Gul

Principal Investigator

Indus Hospital

The sample size calculated was 30 samples per group. After adjusting error in non-response of data collection 50 samples will be drown from each group. Total 100 caregivers along with their children will be selected.

10 children with neuroblastoma. Inclusion after verification of diagnosis and informed consent.
Sampling of fecal microbiome (Initial microbiome, microbiome under chemotherapy, final microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds, fecal volatile organic compounds under chemotherapy and final fecal volatile organic compounds) and breath organic volatile compounds (initial breath organic compounds, breath volatile organic compounds under chemotherapy and final breath volatile organic compounds).
Samples will be taken after verifying diagnosis before initiation of chemotherapy, 1 week after completion of each cycle and 3 weeks after the end of chemotherapy.

10 children without gastro-intestinal or pulmonary disease as age and sex matched controls to the neuroblastoma group. Patients will be recruited from paediatric surgery. Inclusion after informed consent.
Sampling of fecal microbiome (initial fecal microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds) and breath organic volatile compounds (initial breath volatile organic compounds).
Samples will be taken as age and sex matched controls for the neuroblastoma group. Sampling will be done once after obtaining informed consent.

Microbial Colonization

Neuroblastoma

Children, Only

Stool sampling for fecal microbiome analysis by 16S rDNA pyrosequencing. Neuroblastoma group and Control group.

Initial fecal microbiome

Volatile organic compound analysis of stool samples by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.

Initial fecal volatile organic compounds

Breath sampling for organic compound analysis by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.

Initial breath volatile organic compounds

Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to Société Internationale d´Onclogie Pediatrique Neuroblastoma Group (SIOPEN) guidelines

Microbiome under chemotherapy

Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.
Neuroblastoma group

Fecal volatile organic compounds under chemotherapy

Breath sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.
Neuroblastoma group

Breath volatile organic compounds under chemotherapy

Stool sampling 3 weeks after completion of chemotherapy Neuroblastoma group

Final microbiome

Final fecal volatile organic compounds

Breath sampling 3 weeks after completion of chemotherapy Neuroblastoma group

Final breath volatile organic compounds

Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria

Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma

Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma - a Pilot Study

Alpha and beta diversity, relative bacterial abundance at different levels in percent.

Body weight (in kg) and height (in m) will be determined to calculate the body mass index (BMI in kg/m^2).

Body weight (in kg) and height (in m) will be determined to calculate the Body mass index (BMI in kg/m^2).

Assessment of the mucositis score according to the WHO criteria (WHO handbook for reporting results of cancer Treatment; WHO Offset publication no 48) The score contains 5 subitems which are evaluated separately. At the end a total score is derived by adding the results of all items.
Subitem 1: oral mucosa; range 0 (best) to 4 (worst) Subitem 2: nausea and vomiting; range from 0 (best) to 4 (worst) Subitem 3: diarrhea; range from 0 (best) to 4 (worst) Subitem 4: constipation; range from 0 (best) to 4 (worst) Subitem 5: abdominal pain; range from 0 (best) to 4 (worst)

Volatile organic compounds in ppb in the exhaled breath.

Volatile organic compounds in ppb in stool samples.

Medical University of Graz

Neuroblastoma group: Children with neuroblastoma enrolled after verification of diagnosis. Sampling before initiation of chemotherapy and under chemotherapy.
Control group: healthy children without gastro-intestinal or pulmonary disease recruited from paediatric surgery.

The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.

The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.

The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42.

15 mCi/kg of 131I-MIBG

The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.
Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42.

18 mCi/kg of 131I-MIBG

Total

Sex: Female, Male

Region of Enrollment

To determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are tolerable when given with irinotecan/vincristine on a 5-day schedule to children and young adults with high-risk refractory/relapsed neuroblastoma.

Number of Participants With Dose-limiting Toxicity as a Measure of Tolerability

Therapeutic response rate to regimen according to the NANT modified-version of the International Neuroblastoma Response Criteria.

Therapeutic Response Rate

Rate of protocol associated diarrhea according to UGT1A1 genotype.

Wildtype population, no UGT1A1 polymorphisms

Homozygous Wildtype

Population Heterozygous for UGT1A1*28 polymorphisms

Heterozygous UGT1A1*28 Genotype

Population homozygous UGT1A1*28 genotype polymorphisms

Homozygous UGT1A1*28 Genotype

Changes in Diarrhea

To describe changes in standardized uptake values (SUVs) obtained by 18FDG-PET scan at study entry and in response to one cycle of protocol therapy.

Changes in Standardized Uptake Values on FDG-PET Scans

Overall Study

Steven DuBois, MD

Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42.

neuroblastoma/ripuli

Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy

Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma

High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed Neuroblastoma

N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

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