MethylphenIdate for Fatigue in Haematological Cancer

NCT03218254 | Unknown Phase 3

• 1 other identifier: EUDRACT 2017-001844-36
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer related fatigue (CRF) is the most debilitating problem for patients with haematological cancer. CRF severely reduces quality of life (QoL), functional capacity, impacts health behavior, recovery and furthermore no approved treatment exists. In solid cancer methylphenidat (MTP) has been suggested to improve CRF, however patients with haematological cancer has not been studied. The current randomized placebo controlled study includes a variety of severely fatigued haematological cancer patients from seven Danish departments. It aims at revealing whether MTP can improve CRF, functional capacity and QoL thereby hopefully providing improvement and treatment options in this field where improvements are requested the most by patients. Patients are randomized to treatment with MTP or placebo week 1-6 followed by "wash-out" and cross-over - placebo to MTP or vice versa - during week 8-13. End-points will be patient reported fatigue, as well as improvements in active hours, functional capacity, and QoL.

Conditions

Hematological Cancer

Keywords

hematological cancer, fatigue, quality of life

Outcome Measures

Primary Outcomes (1)

• Fatigue score

  end of 6th or 13th week

Study Arms (2)

Methylphenidate - Placebo

OTHER

Methylphenidate before placebo

Drug: Methylphenidate; Drug: Placebo

Placebo - Methylphenidate

OTHER

Methylphenidate after placebo

Drug: Methylphenidate; Drug: Placebo

Interventions

Methylphenidate DRUG

Titration of MTP for treatment of fatigue

Methylphenidate - Placebo; Placebo - Methylphenidate

Placebo DRUG

Placebo

Methylphenidate - Placebo; Placebo - Methylphenidate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malignant haematological disease such as
• Myeloproliferative neoplasm
• Myelodysplasia / Acute Myeloid Leukemia / Chronic Myelomonocytic leukemia
• Acute lymphoblastic leukemia
• Malignant lymphoma
• Chronic lymphocytic leukemia
• Multiple myeloma
• Patient reported fatigue equals to a VAS score of 4 or more on a scale of 0 to 10 on (0 = no fatigue to 10 = worst possible fatigue). Score must be the patients retrospective estimate of usual fatigue during the past two weeks
• Hb ≥ 5 mmol/l on the past three hb measurements
• Age ≥ 18 years
• Ability to read and understand Danish language
• Safe contraception for fertile women

You may not qualify if:

• Chemotherapy within last 8 weeks. Patients on a stable dose previous 4 weeks of the following, may be included:
• Kinase inhibitors (such as Imatinib, Dasatininb, Nilotinib, Ruxulitinib, Bosutinib and others)
• Hydroxyurea
• Chlorambucil
• Busulfan
• Melphalan
• alfa-interferon
• IMIDs (such Thalidomide, Lenalidomide, Pomalidomide and others)
• monoclonal anti-bodies
• azacytidin
• Combinations of above mentioned drugs and with corticosteroids (CS) are allowed as long as CS dose restrictions are followed.
• Glucocorticoid treatment exceeding the equal of prednisolone 10mg / day or equivalent average dose / week and dosage must have remained stable during the past 4 weeks.
• Current infection
• Previous or current diagnosis made by a psychiatrist of psychosis, mania, or Tourette
• Known previous suicidal attempts

Sponsors & Collaborators

• Henrik Frederiksen: lead

Study Sites (1)

Odense University Hospital

Odense, Danmark, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Henrik Frederiksen, MD. PhD

CONTACT

+4521849307; henrik.frederiksen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical placebo tablets are produced. Study pharmacy produces study medication containers and randomizes patients, and keeps track of unique study IDs. Unblinding is only done after completion or in emergency situations
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PHD

Model Details: Methylphenidate or Placebo titrated according to effect and toxicity week 1-6 followed by 1 week of washout and then crossover followed by repeated procedures with the other treatment for week 8-13.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 14, 2017
• Study Start: June 8, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

DK (1)