Page last updated: 2024-11-05

thiotepa and Postpartum Amenorrhea

thiotepa has been researched along with Postpartum Amenorrhea in 2 studies

Thiotepa: A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed).

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19901 (50.00)18.7374
1990's1 (50.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Del Mastro, L1
Venturini, M1
Sertoli, MR1
Rosso, R1
Lacher, MJ1
Toner, K1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Comparison of Hypnotherapy Versus Gabapentin in the Treatment of Hot Flashes in Breast Cancer Survivors or Women at Risk of Developing Breast Cancer.[NCT00711529]Phase 327 participants (Actual)Interventional2008-07-31Completed
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study[NCT00888082]Phase 3102 participants (Anticipated)InterventionalWithdrawn
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Hot Flash Related Daily Interference Score (HFRDIS)

The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks. (NCT00711529)
Timeframe: Week 8

Interventionunits on a scale (HFRDIS) (Median)
Hypnotherapy26
Gabapentin22

Hot Flash Related Daily Interference Score (HFRDIS)

The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point. (NCT00711529)
Timeframe: Week 4

Interventionunits on a scale (HFRDIS) (Median)
Hypnotherapy25.5
Gabapentin21.5

Hot Flash Related Daily Interference Score (HFRDIS)

The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization). (NCT00711529)
Timeframe: Baseline

Interventionunits on a scale (HFRDIS) (Median)
Hypnotherapy58
Gabapentin45.5

Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Baseline

Interventionunits on a scale (severity score) (Median)
Hypnotherapy10
Gabapentin7.5

Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Week 4

Interventionunits on a scale (severity score) (Median)
Hypnotherapy6.5
Gabapentin4

Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Week 8

Interventionunits on a scale (severity score) (Median)
Hypnotherapy1.5
Gabapentin5

Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark." (NCT00711529)
Timeframe: Week 4

Interventiondaily hot flashes (Median)
Hypnotherapy4
Gabapentin4

Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries." (NCT00711529)
Timeframe: Baseline

Interventiondaily hot flashes (Median)
Hypnotherapy5
Gabapentin4.5

Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark." (NCT00711529)
Timeframe: Week 8

Interventiondaily hot flashes (Median)
Hypnotherapy1
Gabapentin3

Reviews

1 review available for thiotepa and Postpartum Amenorrhea

ArticleYear
Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications.
    Breast cancer research and treatment, 1997, Volume: 43, Issue:2

    Topics: Amenorrhea; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy Protocols; Breas

1997
Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications.
    Breast cancer research and treatment, 1997, Volume: 43, Issue:2

    Topics: Amenorrhea; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy Protocols; Breas

1997
Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications.
    Breast cancer research and treatment, 1997, Volume: 43, Issue:2

    Topics: Amenorrhea; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy Protocols; Breas

1997
Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications.
    Breast cancer research and treatment, 1997, Volume: 43, Issue:2

    Topics: Amenorrhea; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy Protocols; Breas

1997

Other Studies

1 other study available for thiotepa and Postpartum Amenorrhea

ArticleYear
Pregnancies and menstrual function before and after combined radiation (RT) and chemotherapy (TVPP) for Hodgkin's disease.
    Cancer investigation, 1986, Volume: 4, Issue:2

    Topics: Adolescent; Adult; Age Factors; Amenorrhea; Antineoplastic Combined Chemotherapy Protocols; Combined

1986