Trial Outcomes & Findings for Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation (NCT NCT01536392)

Last Updated: 2021-06-11

Results Overview

Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

76 participants

Primary outcome timeframe

Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks

Results posted on

2021-06-11

Participant Flow

Recruitment period: March 2012 until June 2016. All the recruitment was done in a medical clinic setting.

76 participants signed consent, 1 participant did not receive treatment due to the study closure.

Participant milestones

Participant milestones
Measure	Arm 1: Transdermal Granisetron 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.	Arm 2: Oral Ondansetron 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
Overall Study STARTED	41	34
Overall Study COMPLETED	28	19
Overall Study NOT COMPLETED	13	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Transdermal Granisetron 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.	Arm 2: Oral Ondansetron 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
Overall Study Adverse Event	2	2
Overall Study Physician Decision	2	3
Overall Study Withdrawal by Subject	3	6
Overall Study Non Compliance	3	4
Overall Study Completed therapy early	3	0

Baseline Characteristics

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Transdermal Granisetron n=41 Participants 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.	Arm 2: Oral Ondansetron n=34 Participants 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	45 Years n=5 Participants	51 Years n=7 Participants	49 Years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	34 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	34 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks

Outcome measures

Outcome measures
Measure	Arm 1: Transdermal Granisetron n=41 Participants 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.	Arm 2: Oral Ondansetron n=34 Participants 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle	49.8 percentage of participants Interval 35.2 to 64.3	39.7 percentage of participants Interval 24.4 to 56.1

SECONDARY outcome

Timeframe: Baseline, up to 24 hours post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks

The response rates to anti-emetic therapy (no emetic or retching episodes and no rescue medication use) in the acute (0-24 hours) phase. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence.

Outcome measures

Outcome measures
Measure	Arm 1: Transdermal Granisetron n=41 Participants 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.	Arm 2: Oral Ondansetron n=34 Participants 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
Percentage of Participants With Response Rate to Anti Emetic Therapy 0-24 Hours Each Chemotherapy Cycle	49.8 percentage of participants Interval 35.2 to 64.3	39.7 percentage of participants Interval 24.4 to 56.1

Adverse Events

Arm 1: Transdermal Granisetron

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm 2: Oral Ondansetron

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1: Transdermal Granisetron n=41 participants at risk 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.	Arm 2: Oral Ondansetron n=34 participants at risk 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
Gastrointestinal disorders Constipation	19.5% 8/41 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks	17.6% 6/34 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks
Gastrointestinal disorders Diarrhea	22.0% 9/41 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks	8.8% 3/34 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks
Gastrointestinal disorders Nausea	36.6% 15/41 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks	35.3% 12/34 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks
General disorders Fatigue	17.1% 7/41 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks	29.4% 10/34 • Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks

Additional Information

Michael Frumovitz, Professor, Gyn Onc & Reproductive Med

UT MD Anderson Cancer Center

Phone: (713) 792-9599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place