Symptoms and General Pathology

All Conditions

Neoplasms

Fatigue

Head and Neck Neoplasms

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

The proposed study is a within-subject, cross-over, randomized and double-blinded pilot trial, designed to evaluate the efficacy and feasibility of sustained-release, long-acting methylphenidate via transdermal patch compared to placebo in fatigued patients with Head and Neck malignancies

The participants will start with a 10mg MPH patch on day -4, the 1st day of the titration period. This will be increased up to 20mg over 4-day titration period as needed and tolerated, and continued on the optimal dose. Subjects will be seen on day 1 of the double-blind part of the study at a patient education room or the Dr.'s office and receive 10 identical patches including 5 MPH and 5 placebo patches that will be randomly assigned over the 10-day course. The patch will be placed at 9am and removed at 4pm daily for 10 days. During the 10 days, each subject will be monitored for continuous 240 hours by actigraphy based activity monitors to follow activity levels and energy expenditure.

methylphenidate via transdermal patch compared to placebo

Natalie Moryl, MD

The purpose of this study is to compare the effects, good and/or bad, of the Methylphenidate patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue caused by cancer or by cancer treatment. The Methylphenidate patch contains a medication that is known to increase alertness and wakefulness. Oral methylphenidate has been used in the past to treat cancer related fatigue and is often used to treat unusual sleepiness. But this is the first time that the patch form is offered to try treating cancer fatigue in patients who cannot always swallow tablets.

Transdermal Methylphenidate for Cancer-Related Fatigue

Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue

In reducing fatigue, increasing activity levels, and sustaining steady wakefulness throughout the day. The outcome measure will be BFI and ESS based self-reporting of the reduction of numeric rating scale on fatigue level and sleepiness, combined with objective measurement of increased activity intensity scores monitored by actigraphy.

In adult head and neck cancer patients with fatigue.

To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure, will be evaluated by examining the patients' rating of their comfort while wearing the actigraphy device and of how willing they would be to wear the device for a future study.

Memorial Sloan Kettering Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Vaginal Neoplasms

Nausea

Vomiting

Uterine Cervical Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Vaginal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Vaginal Cancer

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

Antineoplastic Agents

Emetics

Ondansetron

Cisplatin

Granisetron

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Group A: 34.3 mg of granisetron formulated in transdermal patch replaced every 7 days. Transdermal patch placed/replaced prior to the intravenous (IV) infusion of cisplatin. At cycle 1, participants receive IV granisetron prior to IV cisplatin and prior to administration of transdermal patch.

Group B: 8 mg of ondansetron orally thrice daily starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.

34.3 mg of granisetron formulated in a transdermal patch replaced every 7 days. At cycle 1, participants receive granisetron by vein prior to IV cisplatin and prior to administration of transdermal patch.

8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.

Completion of 3 questionnaires at study visits taking about 5 minutes each time.

Questionnaires

Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.

Study Drug Diary

Michael M. Frumovitz, MD, MPH

The goal of this clinical research study is to compare granisetron (when given through a patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with cervical, endometrial, or vaginal cancer having chemoradiation.

Granisetron and ondansetron are designed to help reduce nausea and vomiting.

Study Groups:

If you agree to take part in this study, and you are among the first 40 participants, you will have an equal chance of being in either group. If you enroll after that, you will have a higher chance (51%-100%) of being assigned to the group that had better results.

* If you are in Group 1, you will receive granisetron by patch.
* If you are in Group 2, you will receive ondansetron by mouth.

Study Drug Administration:

If you are in Group 1, you will receive ondansetron by vein at your first visit only, which is standard of care. Then, you will receive cisplatin by vein over about 1 hour as part of the chemoradiation. A granisetron patch will then be placed on your skin before the chemotherapy . The patch will be replaced every 7 days before the chemotherapy.

If you are in Group 2, you will receive ondansetron by vein before cisplatin. Then, you will receive cisplatin by vein over about 1 hour. Then you will take ondansetron by mouth with a cup of water (8 ounces) 3 times a day for 3 days. Ondansetron is a tablet that you can take with or without food and is best taken at least 30 minutes before eating.

Both groups will be given a study drug diary to record the times that you take the study drugs. You will also record any nausea or vomiting that you may have. You should bring the diary to each study visit. You should also bring your study drug bottles/packages to each study visit.

Study Visits:

The visits for this study will be at the same time as your chemoradiation therapy visits over 5 weeks.

You will complete 3 questionnaires at your study visits and then again 1 week after the last chemotherapy. The last questionnaires will be completed by phone. The questionnaires ask about how easy or difficult it is to use your assigned study drug, your level of nausea and vomiting, and your quality of life. It should take about 5 minutes to complete these questionnaires each time.

Length of Treatment:

You may continue using the study drug up to 5 weeks during your chemoradiation treatment. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over when you have completed 5 weeks of chemoradiation treatments.

This is an investigational study. Both granisetron and ondansetron are FDA approved and commercially available for the treatment of nausea and vomiting. It is investigational to compare these drugs administered in different ways.

Up to 150 patients will take part in this study. Up to 120 participants will take part at MD Anderson. Up to 30 will be enrolled at the Harris Health System.

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

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.

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.

Sancuso

M.D. Anderson Cancer Center

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 1: Transdermal Granisetron

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transdermal Methylphenidate for Cancer-Related Fatigue	NCT01124500	Head and Neck C...	methylphenidate...	21 Years -	Memorial Sloan Kettering Cancer Center
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation	NCT01536392	Cancer of the C...	Granisetron Ondansetron Questionnaires Study Drug Diar...	18 Years -	M.D. Anderson Cancer Center
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation	NCT01536392	Cancer of the C...	Granisetron Ondansetron Questionnaires Study Drug Diar...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for transdermal patch