PPALM-Palm Oil and Pentoxifylline Against Late Morbidity
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 12/31/2018 |
Pirmasis pateikimas: | 08/28/2014 |
Numatytas registravimas pateiktas: | 09/01/2014 |
Pirmas paskelbtas: | 09/02/2014 |
Paskutinis atnaujinimas pateiktas: | 12/19/2019 |
Paskutinis atnaujinimas paskelbtas: | 12/22/2019 |
Faktinė studijų pradžios data: | 11/24/2014 |
Numatoma pirminio užbaigimo data: | 12/19/2019 |
Numatoma studijų užbaigimo data: | 12/19/2019 |
Būklė ar liga
Intervencija / gydymas
Drug: Tocovid SupraBio plus pentoxifylline (PTX)
Drug: Matching placebos
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: Tocovid SupraBio plus pentoxifylline (PTX) Tocovid SupraBio* 200mg po bd plus pentoxifylline (PTX) 400mg po bd for 12 months. | Drug: Tocovid SupraBio plus pentoxifylline (PTX) |
Placebo Comparator: Matching placebos Matching placebos bd for 12 months. | Drug: Matching placebos |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria - - Age over 18 years. - Past history of a malignant pelvic neoplasm (T1-4 N0-2 M0) of the rectum, prostate, testis, bladder, uterine cervix, uterus, vagina, vulva, anal canal or ovary. - A minimum 12 months follow-up post-radiotherapy (24 months for patients with past history of stage T4 and/or N2 disease). - A maximum 7 years post-radiotherapy - No evidence of cancer recurrence. - Gastrointestinal symptoms attributable to prior radiotherapy: grade 2 or higher in any CTCAE Version 4 category, or grade 1 with difficult intermittent symptoms. - Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period. - Physical and psychological fitness for Tocovid SupraBio+PTX therapy. - Written informed consent and availability for follow up. - Willingness to keep to a specified level of dietary fat intake during the study. Exclusion Criteria - - Surgery for rectal cancer. - Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy. - Dietary supplementation containing alpha-tocopherol above a daily dose of 30mg at any time during the last three months. - Medication with pentoxifylline at any time since radiotherapy. - Pregnancy or breast feeding. - Ischaemic heart disease, uncontrolled hypertension, hypotension, acute myocardial infarction, cerebral haemorrhage, retinal haemorrhage, renal failure, liver failure and medication with insulin, ketorolac or vitamin K. - Allergy to soya. - Known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients', as per SmPC for pentoxifylline. |
Rezultatas
Pirminės rezultatų priemonės
1. Change at 12 months in the bowel disease subset of the Modified IBDQ Quality of Life questionnaire. [Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.]
Antrinės rezultatų priemonės
1. Change at 12 months in rectal IBDQ bleeding score between the two groups in those patients presenting with grade 2, 3 or 4 bleeding. [Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.]
2. Change at 12 months in IBDQ faecal incontinence score between the two groups in those patients presenting with grade 1 or greater incontinence. [Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.]
3. Proportion of items graded as marked or severe (grade 3 or 4). [Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.]
4. Physician assessment of rectal dysfunction based on the modified CTCAE Version 4 grading. [Endpoint will be assessed pre-treatment and 6, 12 & 24 months post-treatment.]
5. Patient self-assessments: QLQ-C30 and CR29 and the Gastrointestinal Symptom Rating Scale. [Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.]
6. Photographic assessment of rectal mucosa. [Endpoint will be assessed pre-treatment and 12 & 24 months post-treatment]
7. Serum fibrosis marker levels. [Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.]
Kitos rezultato priemonės
1. Translational endpoint: Rectal biopsies (optional) [Endpoint will be assessed pre-treatment and 12 & 24 months post-treatment.]
2. Translational endpoint: Blood samples [Endpoint will be assessed pre-treatment and 12 & 24 months post-treatment.]