Return to List

Study Summary
No. ID00-372:.......Breast; Gastrointestinal; Lung; Lymphoma; Myeloma......Carmen Escalante......General Internal Medicine/Ambulatory Treatment & Emergency Care
.
Study Summary Title
Study Summary
Number:
ID00-372
Study Title:A randomized, double blind, two period, placebo-controlled crossover trial of a sustained release methylphenidate in the treatment of fatigue in cancer patients
.
Physician New Patient Referral
Name:Carmen EscalantePatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:General Internal Medicine/Ambulatory Treatment & Emergency CareReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4516
Contact us about clinical trials
.
General Information
Disease Group:Breast
Gastrointestinal
Lung
Lymphoma
Myeloma
Supported By:N/A
Phase of Study:Phase IIIReturn
Visit:
5
Treatment
Agents:
OROSŪ MethylphenidateHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to see if the drug OROS
Methylphenidate HCl (Concerta) can help to control fatigue in patients with
breast, gastrointestinal, lymphoma, myeloma or lung cancer who are going
through chemotherapy or hormonal treatment. The safety of this drug will also
be studied. Another goal of the study is to see how certain cytokines change
while patients undergo chemotherapy or hormonal treatment.
.
Study Objectives / Outcomes
To assess the efficacy of OROS Methylphenidate as compared to placebo for improvement of fatigue in patients with breast, gastrointestinal, lymphoma, myeloma or lung cancer who are undergoing chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months.

To examine cytokine levels and their correlation with fatigue and cognitive function.
.
Study Status Information
Study Activation / Registration Date:08/30/2004
IRB Review and Approval Date:12/20/2000
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancer undergoing chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months

2) Patient is > or = 18 years of age

3) Patient has Brief Fatigue Inventory "fatigue worst" score of > or = 4 at baseline

4) Patient has an ECOG performance status of < or = 2 at baseline

5) Patient has a life expectancy > or = 6 months from the start of the study

6) Patient is using acceptable birth control methods. Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Medically acceptable methods of contraception include abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization

7) Patient must speak and understand English

8) Patient has provided written informed consent to participate in the study prior to enrollment to the study

Exclusion Criteria:1) History of hypersensitivity reaction to methylphenidate

2) History of or current seizure disorder, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, tension or agitation

3) History of clinically significant cardiac disease (see protocol for criteria)

4) Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently (defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg

5) History of fibromyalgia

6) Use of alcohol while participating in the study

7) Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential (see protocol for criteria)

8) Moderate to severe depression (> or = 20 on Beck Depression Index II)

9) If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days

10) Currently taking psychostimulants (including appetite suppressants), MAO inhibitors, anticoagulant or anticonvulsant therapy

11) Current use of corticosteroids, medications, or stimulants (i.e., vivarin) used to improve fatigue symptoms

12) Use of an investigational medication within the past month

13) Current use of the following herbals or supplements for fatigue relief (DHEA, SAME, ginkgo, ginseng, St. John's Wort (including DHEA, SAME, ginkgo, ginseng, St. John's Wort, metabolite, effedrine, basil, citronella, fennel, horseradish roots, lavender flowers, lemon verbena, marjoram, mint, nettle, pine needles, rosemary, sage, savory, thyme, bay, cayenne pepper, cinnamon, eucalyptus, hyssop, myrrh, oregano, peppermint, ginseng, green, black or Chinese tea, ephedra (aka - ma-huang), popotillo, and Mormon tea)

14) Any coexisting medical condition or are taking any concomitant medication that is likely to interfere with the safe administration of methylphenidate

15) Patients who start epoetin within 30 days prior to enrollment

16) Patients who start taking epoetin during the first week of the study

17) Hemoglobin < 8.0 gm/dl

18) Patients with a TSH value > or = 1.5 times the upper limit of normal (ULN)

19) Albumin value 50% lower than the lower limit of normal

20) Evidence of hepatic impairment [total bilirubin > or = 2.5 times ULN (normal range of 0 – 1.0 mg/dl, SGPT > or = 2.5 times ULN)]

21) Evidence of renal impairment (serum creatinine > 2.5 times ULN, normal range of 0.8 – 1.5 mg/dl)

22) A severe narrowing (pathological or iatrongenic), obstruction of the gastrointestinal tract, or gastrointestinal malabsorption

23) If taking anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days

24) Patients with nausea, vomiting, or diarrhea of CTCAE grade III or higher

25) If taking anticonvulsants for sensory neuropathy (Gabapentin or Pregabalin), no changes in dose and/or no start of new course of treatment in the last 30 days

26) History of severe headaches within 30 days prior to enrollment

.
Links
Registration Number: NCT00516269
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center