Patients will be asked to provide stool and urine samples and complete symptom assessment questionnaires at 6 time points: baseline (before treatment), 2 and 6 weeks after starting radiotherapy, 6 months after completion of radiotherapy and 12 and 24 months after completion of treatment. In addition, patients will be asked to provide a rectal swab and a saliva sample, which will be stored and potentially used at a later stage to characterize any differences in the microbial populations present. (Funding will be sought elsewhere to analyse these samples).

Cancer

Toxicity

Malignancy

Study participation will be offered to women, newly diagnosed with a gynecological malignancy who are due to be treated with pelvic radiotherapy.

Cohort Observation

The Royal Marsden NHS Foundation Trust

Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy

A 6 point difference in the olfactory signatures in different samples (rectal swab, stool sample,urine, sample saliva sample) between patients who develop severe toxicity* and those with no or minimal toxicity.

The Bristol stool chart categorizes the types of stool a person passes into 7 categories. It is a helpful tool to assess stool consistency in combination with other tools assessing GI symptoms, however it does not describe the severity of toxicity so no cut off values.

For IBDQ a higher score will indicate a better Quality of Life (QoL). A change in IBDQ will indicate the level of patients QoL over the study period.

Royal Marsden NHS Foundation Trust

University of Warwick

whole blood, serum, white cells, red blood cells, urine, breast milk, meconium

Exposure to Environmental Pollution

Rambam Medical Center

Lis Medical Center

Assaf Harofeh Medical Center

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

assessment of BFRs and phthalates body burdens through measurement of these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and neonatal meconium among several representative sub-populations

To examine associations between exposure to PBDEs and phthalates and (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted for gestational age, ponderal index, head circumference adjusted for gestational age), and (c) cryptorchidism incidence, (d) maternal and infant thyroid function

To establish a bio repository of these media for future studies and to establish follow up methods for this cohort to later assess development and growth in the infants, toddlers and children

Assaf-Harofeh Medical Center

Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.

Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.
Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.
Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.
Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2

Sodium Thiosulfate (STS) Ear & Placebo Ear

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Region of Enrollment

To assess the efficacy of intratympanic sodium thiosulfate (STS) on reducing the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy using puretone and speech audiometry, and distortion product otoacoustic emissions (DPOAE).
Pure tone and speech audiometry: hearing will be assessed prior to any initiation of cisplatin therapy, again at three weeks, 6 weeks, 12 weeks, and every 6 months thereafter for up to one year.

Efficacy of Intratympanic Sodium Thiosulfate (STS)

Overall Study

David Cognetti, MD

If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.

Insertion of Pressure Equalization (PE) Tubes

Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.

Sodium Thiosulfate (STS)

Drops of balanced saline solution will be added to the placebo comparator ear prior to initial cisplatin infusion.

Saline (Placebo)

Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2

Cisplatin

Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

Thomas Jefferson University

The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy

A Pilot, Randomized, Self-controlled Study of the Effects of Intratympanic Sodium Thiosulfate on the Degree of Hearing Loss in Patients Receiving Cisplatin Therapy

cyanide/rak

Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy

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