JPRN-jRCT1031200069RecruitingPhase 2
Efficacy of exercise intervention for fatigue of gynecologic cancer patients receiving chemotherapy (multicenter randomized controlled trial)
Miyagi Etsuko0 sites110 target enrollmentStarted: July 16, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to < 80age old (—)
- Sex
- Female
Inclusion Criteria
- •(1) Patients aged 20 to 80 at the time of registration
- •(2) Patients who are diagnosed with gynecologic cancer (cervical cancer, endometrial cancer, ovarian cancer) and who meet the following requirements.
- •*Peritoneal cancer and fallopian tube cancer are included in ovarian cancer
- •*Double cancer among the above gynecologic cancers are allowed.
- •(3) Patients who will be received tri-weekly TC therapy for the first time as the primary or recurrent treatment. Preoperative chemotherapy is not included. Postoperative adjuvant chemotherapy, remission induction therapy, and recurrent treatment are targeted. Bevacizumab combination with TC therapy is allowed in the ovarian cancer and cervical cancer.
- •(4) ECOG Performance Status (PS) is 0-2.
- •(5) Patients who can answer questionnaire surveys
- •(6) Patients who have signed an approved informed consent to participate in this study
Exclusion Criteria
- •(1) Patients who clearly need rehabilitation before the start of treatment due to other diseases or poor general condition
- •(2) Patients who are considered to be unable to undergo at least two cycles of chemotherapy at least due to complications (intestinal obstruction, thrombosis, etc.) or the progression of the cancer
- •(3) Patients with other malignant tumors requiring for treatment at the same time (Patients who have a history and are currently in remission are tolerated)
- •(4) Patients with depression currently under treatment and sleep disorders requiring sleeping pills
- •(5) Patients with serious heart disease
- •I) exertional angina ii) severe arrhythmia iii) resting chest pain
- •Iv) Poor hemodynamics immediately after myocardial infarction
- •(6) Patients with palpitations or shortness of breath of NYHA III degree or above and chest pain before rehabilitation
- •(7) Patients who participated clinical trials or clinical trials of drugs or medical devices, etc. within 30 days before inclusion in this study or who may participated in the other clinical trial during this trial.
- •(8) Patients who are judged to be unsuitable as a subject by the doctor or researcher
Investigators
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