Could a plant extract make rectal cancer treatment easier to tolerate?
NCT ID NCT05856305
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding chlorophyllin, a natural plant extract, to standard chemoradiation can reduce side effects like diarrhea, bladder irritation, and low blood counts in people with locally advanced rectal cancer. About 76 adults will receive either chlorophyllin or a placebo alongside their cancer therapy. The goal is to see if chlorophyllin helps patients feel better and increases the chance of avoiding surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chlorophyllin (a natural plant extract)
- What this could lead to
- If it works, this could offer a simple way to reduce painful side effects from cancer treatment and help more patients avoid surgery.
- What could go wrong
- This is a small, early-phase trial with only 76 participants. The benefit may be small or not seen at all, and chlorophyllin might not reduce side effects significantly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
76 people
The number who actually took part.
- Started
-
Jul 2023
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \> 18 years. * Histologically confirmed diagnosis of adenocarcinoma of the rectum. * Clinical Stage II/III (T2-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0-2) based on MRI. * Non-circumferential tumours with craniocaudal length \<7 cm * The tumours of the lower rectum, or starting up to 7 cm from the anal verge. * No evidence of distant metastases on CT Chest and Abdomen. * No prior pelvic radiation therapy * No prior chemotherapy or surgery for rectal cancer * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 * Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. * Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team. * Absolute neutrophil count (ANC) \> 1.5 cells/mm3, hemoglobin (HGB) \> 8.0 gm/dl, platelet (PLT) \> 150,000/mm3. * Total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), aspartate aminotransferase (AST) ≤ 3 x ULN, alanine transaminase (ALT) ≤ 3 x ULN. Exclusion Criteria: * Signet or mucinous histology cancer of rectum * Recurrent rectal cancer or previous pelvic radiotherapy * Primary unresectable rectal cancer. * Creatinine level greater than 1.5 times the upper limit of normal. * Patients who are unable to undergo an MRI. * Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA. * Ulcerative colitis or any other histologically confirmed inflammatory bowel disease. * Patients with a history of venous thrombotic episodes such as deep venous thrombosis, and pulmonary embolism occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for a trial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy. * Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study. * Poor reliability for follow up. * Ineligible as per eligibility criteria
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
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